G-EO Gait Rehabilitation Training in Progressive Multiple Sclerosis

Sponsor
Indiana University (Other)
Overall Status
Completed
CT.gov ID
NCT03980145
Collaborator
University of Alabama at Birmingham (Other), University of Ottawa (Other)
15
1
2
34
0.4

Study Details

Study Description

Brief Summary

The logistic advantages and advanced training capabilities of the G-EO System, as well as the benefits reported in other populations, support this strategy as a potentially potent rehabilitation tool for restoring and maintaining function in progressive Multiple Sclerosis (MS). This approach represents a paradigm shifting opportunity for improving current clinical practices for patients with progressive MS. If successful, this project will provide initial evidence for increasing patient access to the G-EO System, and this could be accomplished through "regional technology centers" using a rural health-delivery approach.

There are several novel aspects of the proposed trial: (1) the examination of a novel gait rehabilitation stimulus (G-EO System) that could alter current clinical practices; (2) the focus on patients with progressive MS who have gait impairment (i.e., those who have received minimal research attention), which was recently described as the greatest therapeutic challenge facing the MS community; and (3) a study design that accounts for standard therapy.

Specific Aims: The investigators designed a single-blinded, randomized pilot trial of electromechanically-assisted gait training using the G-EO System in patients with progressive MS with gait disability (EDSS=4.0-7.5).

Specific Aim 1 will establish the safety and feasibility of gait training using the G-EO System.

Specific Aim 2 will determine the efficacy of gait training using the G-EO System for improving mobility, symptomatic, quality of life, and participatory outcomes.

Condition or Disease Intervention/Treatment Phase
  • Device: G-EO System (Reha Technology AG: Olten, Switzerland)
  • Other: Conventional Physical Therapy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
G-EO Gait Rehabilitation Training in Progressive Multiple Sclerosis
Actual Study Start Date :
May 2, 2017
Actual Primary Completion Date :
Mar 1, 2020
Actual Study Completion Date :
Mar 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Conventional Physical Therapy

Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.

Other: Conventional Physical Therapy
Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.

Experimental: End-Effector Robotic Training

G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern.

Device: G-EO System (Reha Technology AG: Olten, Switzerland)
Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases.13,14 The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence in stroke survivors. This system involves minimal therapist and patient burden (e.g., quick set-up, single operate usage), there is the unique capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
Other Names:
  • Electromechanically-assisted gait training
  • Robotic end-effector gait training system
  • Outcome Measures

    Primary Outcome Measures

    1. Comfortable Walking Speed [Gait speed for comfortable walking will be assessed prior to the start of the treatment (Pretest) and following study completion which occurred following 20 treatment visits (Posttest)]

      Comfortable Walking speed will be assessed using a Pressure Sensor Walkway. Participants will be asked to walk over a 14 foot pressure mat that will capture their walking speed. Scores range from 0 (no speed) to as fast as they are comfortable with the most common range being .1 to 1.5 meters per second.

    2. Two Minute Walk Test [Walking distance will be assessed prior to the start of the treatment (Pretest) and following study completion (Posttest). Pretest represents a time point prior to intervention training. Posttest represents the point following intervention completion.]

      A 2-minute walk (2MWT) test to determine walking endurance. Subjects will be asked to walk for 2 minutes along a 30m track. Subjects may stop and rest as often as needed. The outcome is the distance in meters traveled during the 2 minutes. Scores can range from 0 to 500 meters. An increase in distance following treatment when compared to pretest numbers would indicate improved muscular and cardiovascular endurance.

    3. Modified Fatigue Impact Scale [Subjects perception of the their fatigue will be assessed prior to the start of the treatment and following study completion (at 10 weeks)]

      Subjects will complete a questionnaire evaluating their level of perceived fatigue. The scores are divided into three different scales: physical, cognitive, and psychosocial. A total score is also calculated. Scale scores are represented by the following ranges: physical subscale ranges from 0 to 36; cognitive subscale from 0 to 40; and psychosocial subscale from 0 to 8. A total score has a range of 0 to 85. A higher score indicates greater fatigue. Decreases in scores over time indicate decreases in feelings of fatigue. Each scale including the total score is summed.

    4. Multiple Sclerosis Impact Scale-29 [Subjects perception of the their disability will be assessed prior to the start of the treatment and following study completion (at 10 weeks)]

      Subjects completed a 29 item questionnaire evaluating their level of health-related quality of life. The higher the score the greater the impact MS is having on their daily function. The 29 items are divided into a 20 item physical scale and 9 item psychological scale. Each item has four potential responses resulting in scores on the physical impact scale ranging from 20 to 80 and on the psychological impact scale ranging from 9 to 36. Final scores for each scale are achieved by summing the items for each of the two scales and then transforming them to a 100 point scale for easy comparison. On the 100 point scale, 0 would indicate no impact of the disease on daily function and 100 would indicate the greatest possible impact.

    5. Fast Walking Speed [Fast walking speed will be assessed prior to the start of the treatment (Pretest) and following study completion (Posttest). Pretest represents a time point prior to intervention training. Posttest represents the point following intervention completion.]

      Fast Walking speed will be assessed using a Pressure Sensor Walkway. Participants will be asked to walk over a 14 foot pressure mat that will capture their walking speed. Scores range from 0 (no speed) to as fast as they are able with the most common range being .5 to 2.0 meters per second.

    Secondary Outcome Measures

    1. Hospital Anxiety and Depression Scale (HADS) [Subjects perception of the their anxiety and depression will be assessed prior to the start of the treatment and following study completion (at 10 weeks)]

      Subjects completed a questionnaire evaluating their level of anxiety and depression. The questionnaire is comprised of two scales: a 7 item scale related to anxiety and 7 item scale related to depression. Each item within both scales is scored using a 0-3 scoring system depending upon the individual's answer. Both the anxiety scale and the depression scale can range in scores from 0 to 21. Although the 14 items were administered together, each set of seven questions was kept separate and scored separately to create a score for anxiety and one for depression. The scores for each scale were summed to provide a total score for anxiety and a separate score for depression. The higher the score the greater the severity. A score between 8-10 is consider mild, 11-14 is moderate, >14 is severe for both scales.

    2. Short Form McGill Pain Questionnaire [Subjects perception of the their pain will be assessed prior to the start of the treatment and following study completion (at 10 weeks)]

      Subjects completed a questionnaire evaluating their level of pain. There are 15 adjectives that describe the patient's pain. The patient ranks each of the words on a categoric scale of "none, mild, moderate, severe. Sensory and affective scores will be computed separately. Scores are created from a summary of the responses using an intensity scale of 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher the score the more severe the pain is for each of the subscales. For this study, sensory, affective, and total pain scores are reported. The minimum sensory, affective, and total score score would be zero. The maximum score for sensory is 33, affective is 12, and total is 45.

    3. Late-Life Disability Inventory (LLFDI) [Subjects perception of the their functional ability using the total score and dimensional scores will be assessed prior to the start of the treatment and following study completion (at 10 weeks)]

      Subjects will complete a questionnaire evaluating their perceived level of disability. This tool assesses and responds to meaningful change in a persons disability (Ability to participate in life's activities). There is a 16 item disability component that is scored across two dimensions: frequency and limitation. Total scores and dimensional scores are created by summation and conversion to a 100 point scaled score. The instrument provides a table for converting the raw score to a scaled score. The lowest possible scale score is 0 and the highest score is 100 for both frequency and limitation. A higher score indicates greater functional ability and less disability. Each dimension can be further assessed by analyzing domains. There are social and personal domains within the frequency dimension and instrumental and management domains within the limitations dimension. All domains are calculated as described before through summation and scale adjustment.

    4. Late-Life Function Inventory [Subjects perception of the their functional ability using all three domains will be assessed prior to the start of the treatment and following study completion (at 10 weeks)]

      Subjects will complete a questionnaire evaluating their perceived level of function. This tool assesses and responds to meaningful change in a persons function (ability to execute discrete tasks). There is a 32 item functional component is comprised of three domains Upper Extremity, Basic Lower Extremity, Advanced Lower Extremity. Total score and each domain will be scored by summing and then converting to a 100 point scaled score. The instrument provides a table for converting the raw score to a scaled score. A higher score indicates greater functional ability. The lowest score would be 0 and the highest scale score would be 100.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 18-64 years

    • Confirmed diagnosis of Primary or Secondary Progressive Multiple Sclerosis (this will be confirmed by the referring physician)

    • EDSS 4.0-7.522

    • Stable course of disease-modifying therapy over the past 6 months

    • Asymptomatic (i.e., no underlying cardiovascular disease)

    • Physician approval for exercise

    • Willingness to visit the IU Health Neurosciences Center for testing and training

    Exclusion Criteria:
    • Pregnancy

    • Current use of dalfampridine (Ampyra┬«)

    • Conventional physical therapy or G-EO training within the past 6 months

    • Height <1m or >2m

    • Body weight >150 kg

    • Contraindications to G-EO gait training (e.g., bone instability)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Neurorehabilitation and Robotics at IU Health Neuroscience Center Indianapolis Indiana United States 46202

    Sponsors and Collaborators

    • Indiana University
    • University of Alabama at Birmingham
    • University of Ottawa

    Investigators

    • Principal Investigator: Peter Altenburger, PhD, PT, Indiana University

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Peter Altenburger, Associate Professor, Health and Rehabilitation, Indiana University
    ClinicalTrials.gov Identifier:
    NCT03980145
    Other Study ID Numbers:
    • 1701909134
    First Posted:
    Jun 10, 2019
    Last Update Posted:
    Feb 14, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Peter Altenburger, Associate Professor, Health and Rehabilitation, Indiana University
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Conventional Physical Therapy End-Effector Robotic Training
    Arm/Group Description Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern. G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases.13,14 The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence. This system has a unique capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
    Period Title: Overall Study
    STARTED 7 8
    COMPLETED 7 8
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Conventional Physical Therapy End-Effector Robotic Training Total
    Arm/Group Description Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern. G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases. The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence. This system has the capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback. Total of all reporting groups
    Overall Participants 7 8 15
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    7
    100%
    8
    100%
    15
    100%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    56.0
    (11.58)
    49.4
    (14.46)
    52.5
    (13.18)
    Sex: Female, Male (Count of Participants)
    Female
    4
    57.1%
    7
    87.5%
    11
    73.3%
    Male
    3
    42.9%
    1
    12.5%
    4
    26.7%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    7
    100%
    8
    100%
    15
    100%
    Expanded Disability Status Scale (EDSS) (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    6.0
    (0.33)
    5.81
    (0.88)
    5.9
    (0.74)

    Outcome Measures

    1. Primary Outcome
    Title Comfortable Walking Speed
    Description Comfortable Walking speed will be assessed using a Pressure Sensor Walkway. Participants will be asked to walk over a 14 foot pressure mat that will capture their walking speed. Scores range from 0 (no speed) to as fast as they are comfortable with the most common range being .1 to 1.5 meters per second.
    Time Frame Gait speed for comfortable walking will be assessed prior to the start of the treatment (Pretest) and following study completion which occurred following 20 treatment visits (Posttest)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Conventional Physical Therapy End-Effector Robotic Training
    Arm/Group Description Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern. G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases. The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence. This system has the capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
    Measure Participants 7 8
    Pretest Assessment (Prior to starting intervention training)
    .45
    (.080)
    .60
    (.137)
    Posttest Assessment (After completing intervention training)
    .52
    (0.90)
    .67
    (.163)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Null hypothesis is no difference between the two groups
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .405
    Comments Statistical significance set at .05
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection End-Effector Robotic Training
    Comments Null hypothesis is no difference between pretest and posttest
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .133
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy
    Comments Evaluated the difference between the pretest and posttest within the conventional physical therapy group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .050
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Evaluating the impact of whether comfortable walking speed for both groups combined resulted in a significant improvement in walking speed
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .017
    Comments p value was adjusted for multiple comparisons using a Bonferroni correction
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value .070
    Confidence Interval (2-Sided) 95%
    .015 to .124
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Primary Outcome
    Title Two Minute Walk Test
    Description A 2-minute walk (2MWT) test to determine walking endurance. Subjects will be asked to walk for 2 minutes along a 30m track. Subjects may stop and rest as often as needed. The outcome is the distance in meters traveled during the 2 minutes. Scores can range from 0 to 500 meters. An increase in distance following treatment when compared to pretest numbers would indicate improved muscular and cardiovascular endurance.
    Time Frame Walking distance will be assessed prior to the start of the treatment (Pretest) and following study completion (Posttest). Pretest represents a time point prior to intervention training. Posttest represents the point following intervention completion.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Conventional Physical Therapy End-Effector Robotic Training
    Arm/Group Description Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases. The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence. This system has the capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
    Measure Participants 7 8
    Pretest Assessment (Prior to the start of intervention training)
    66.57
    (10.90)
    89.35
    (21.38)
    Posttest Assessment (Following completion of intervention training)
    72.62
    (14.23)
    93.21
    (19.14)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Comparison of the impact between the two arms looking an improved walking endurance
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .369
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection End-Effector Robotic Training
    Comments Evaluation of impact of end-effector robotic training alone
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .710
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy
    Comments Evaluating the impact of conventional therapy on walking endurance Null hypothesis is no difference between pretest and posttest
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .682
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Evaluating the impact of whether both groups combined resulted in a significant change in walking distance
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .568
    Comments p value adjusted for multiple comparisons - Bonferroni
    Method ANOVA
    Comments
    3. Primary Outcome
    Title Modified Fatigue Impact Scale
    Description Subjects will complete a questionnaire evaluating their level of perceived fatigue. The scores are divided into three different scales: physical, cognitive, and psychosocial. A total score is also calculated. Scale scores are represented by the following ranges: physical subscale ranges from 0 to 36; cognitive subscale from 0 to 40; and psychosocial subscale from 0 to 8. A total score has a range of 0 to 85. A higher score indicates greater fatigue. Decreases in scores over time indicate decreases in feelings of fatigue. Each scale including the total score is summed.
    Time Frame Subjects perception of the their fatigue will be assessed prior to the start of the treatment and following study completion (at 10 weeks)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Conventional Physical Therapy End-Effector Robotic Training
    Arm/Group Description Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases.13,14 The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence in stroke survivors. This system involves minimal therapist and patient burden (e.g., quick set-up, single operate usage), there is the unique capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
    Measure Participants 7 8
    Pretest Total Score
    50.14
    (4.93)
    43.75
    (4.61)
    Posttest Total Score
    40.71
    (5.20)
    34.25
    (4.87)
    Pretest Physical Domain
    23.71
    (3.74)
    25.88
    (1.74)
    Posttest Physical Domain
    24.57
    (1.55)
    19.50
    (2.33)
    Pretest Cognitive Domain
    20.43
    (1.78)
    14.37
    (4.04)
    Posttest Cognitive Domain
    12.14
    (2.86)
    11.88
    (3.54)
    Pretest Psychological Domain
    6.0
    (.436)
    3.50
    (.964)
    Posttest Psychological Domain
    4.0
    (.535)
    2.88
    (.766)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Evaluation of the physical domain
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .594
    Comments Outcome specific to the physical domain
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection End-Effector Robotic Training
    Comments Pretest- Posttest End Effector Robotic Training Comparison for the Physical Domain
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .061
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy
    Comments Pretest posttest comparison of conventional training group for physical domain
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .812
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Combined conventional and end-effector training for outcomes in the physical domain
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .235
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Between group assessment of changes in the MFIS Cognitive domain
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .465
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection End-Effector Robotic Training
    Comments Within group differences for the End Effector Robotic Training Group for the Cognitive Domain
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .165
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy
    Comments Within group assessment for the conventional group within the cognitive domain of the MFIS
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .682
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Combined group outcomes comparing pretest to posttest for the cognitive domain
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .017
    Comments p value adjusted using a Bonferroni correction
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.39
    Confidence Interval (2-Sided) 95%
    1.12 to 9.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Between group comparison for the MFIS Psychological Subscale
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .052
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection End-Effector Robotic Training
    Comments Within group comparison for the end-effector robotic training group for the MFIS Psychological subscale
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .483
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy
    Comments Within group assessment for the conventional physical therapy group for the MFIS Psychological subscale
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .056
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Change in MFIS for all subjects from pre to posttest for the psychological subscale
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .048
    Comments p value is adjusted for multiple comparisons using a Bonferroni correction
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.313
    Confidence Interval (2-Sided) 95%
    .016 to 2.619
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Between group assessment of differences in total score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .010
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection End-Effector Robotic Training
    Comments Within assessment of change in total fatigue score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .089
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy
    Comments Within group assessment of change in total score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .50
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Combined assessment of all subject improvement in total MFIS score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.10
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 9.464
    Confidence Interval (2-Sided) 95%
    2.678 to 16.251
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Primary Outcome
    Title Multiple Sclerosis Impact Scale-29
    Description Subjects completed a 29 item questionnaire evaluating their level of health-related quality of life. The higher the score the greater the impact MS is having on their daily function. The 29 items are divided into a 20 item physical scale and 9 item psychological scale. Each item has four potential responses resulting in scores on the physical impact scale ranging from 20 to 80 and on the psychological impact scale ranging from 9 to 36. Final scores for each scale are achieved by summing the items for each of the two scales and then transforming them to a 100 point scale for easy comparison. On the 100 point scale, 0 would indicate no impact of the disease on daily function and 100 would indicate the greatest possible impact.
    Time Frame Subjects perception of the their disability will be assessed prior to the start of the treatment and following study completion (at 10 weeks)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Conventional Physical Therapy End-Effector Robotic Training
    Arm/Group Description Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases.13,14 The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence in stroke survivors. This system involves minimal therapist and patient burden (e.g., quick set-up, single operate usage), there is the unique capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
    Measure Participants 7 8
    Pretest Physical Subscale
    65.89
    (4.26)
    47.97
    (7.97)
    Posttest Physical Subscale
    52.32
    (5.14)
    33.13
    (8.14)
    Pretest Psychological Subscale
    55.16
    (3.12)
    30.56
    (7.57)
    Posttest Psychological Subscale
    32.94
    (3.34)
    26.39
    (7.84)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Null hypothesis set for no difference between groups Assessment of between group differences for the physical subscale
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .071
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection End-Effector Robotic Training
    Comments With group assessment of change on the physical subscale of the MSIS
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .005
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 14.84
    Confidence Interval (2-Sided) 95%
    6.02 to 23.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy
    Comments With group assessment of change on the physical subscale of the MSIS
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .001
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 13.57
    Confidence Interval (2-Sided) 95%
    8.30 to 18.85
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Combined group assessment of change on the physical subscale of the MSIS
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .000026
    Comments p value adjusted for multiple comparisons using Bonferroni
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 14.21
    Confidence Interval (2-Sided) 95%
    9.367 to 19.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Between group comparison for the psychological subscale for the MSIS
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .084
    Comments Pretest measures were statistically different between the two groups
    Method ANOVA
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection End-Effector Robotic Training
    Comments Within group comparison for the psychological subscale for the MSIS
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .412
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy
    Comments Within group comparison for the psychological subscale for the MSIS
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .00018
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 22.22
    Confidence Interval (2-Sided) 95%
    15.59 to 28.85
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Combined group comparison for the psychological subscale for the MSIS
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .00049
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 13.19
    Confidence Interval (2-Sided) 95%
    7.013 to 19.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Primary Outcome
    Title Fast Walking Speed
    Description Fast Walking speed will be assessed using a Pressure Sensor Walkway. Participants will be asked to walk over a 14 foot pressure mat that will capture their walking speed. Scores range from 0 (no speed) to as fast as they are able with the most common range being .5 to 2.0 meters per second.
    Time Frame Fast walking speed will be assessed prior to the start of the treatment (Pretest) and following study completion (Posttest). Pretest represents a time point prior to intervention training. Posttest represents the point following intervention completion.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Conventional Physical Therapy End-Effector Robotic Training
    Arm/Group Description Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases.13,14 The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence in stroke survivors. This system involves minimal therapist and patient burden (e.g., quick set-up, single operate usage), there is the unique capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
    Measure Participants 7 8
    Pretest Assessment (Prior to intervention training)
    .55
    (.108)
    .81
    (.190)
    Posttest Assessment (following completion of intervention training)
    .63
    (.131)
    .84
    (.205)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Null hypothesis is no difference between the two groups
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .352
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy
    Comments Within group assessment
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .079
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection End-Effector Robotic Training
    Comments Within group assessment
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .393
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Evaluating the impact of whether fast walking speed for both groups combined resulted in a significant improvement in walking speed
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .048
    Comments
    Method ANOVA
    Comments Adjusted for multiple mean comparisons
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value .058
    Confidence Interval (2-Sided) 95%
    .001 to .116
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Hospital Anxiety and Depression Scale (HADS)
    Description Subjects completed a questionnaire evaluating their level of anxiety and depression. The questionnaire is comprised of two scales: a 7 item scale related to anxiety and 7 item scale related to depression. Each item within both scales is scored using a 0-3 scoring system depending upon the individual's answer. Both the anxiety scale and the depression scale can range in scores from 0 to 21. Although the 14 items were administered together, each set of seven questions was kept separate and scored separately to create a score for anxiety and one for depression. The scores for each scale were summed to provide a total score for anxiety and a separate score for depression. The higher the score the greater the severity. A score between 8-10 is consider mild, 11-14 is moderate, >14 is severe for both scales.
    Time Frame Subjects perception of the their anxiety and depression will be assessed prior to the start of the treatment and following study completion (at 10 weeks)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Conventional Physical Therapy End-Effector Robotic Training
    Arm/Group Description Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases.13,14 The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence in stroke survivors. This system involves minimal therapist and patient burden (e.g., quick set-up, single operate usage), there is the unique capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
    Measure Participants 7 8
    Pretest HADS Anxiety Score
    8.43
    (1.445)
    5.88
    (1.076)
    Posttest HADS Anxiety Score
    7.14
    (1.223)
    4.75
    (1.161)
    Pretest HADS Depression Score
    7.57
    (.869)
    4.75
    (1.187)
    Posttest HADS Depression Score
    7.00
    (.845)
    3.88
    (1.445)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Between group assessment for the HADS Anxiety Subscale
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .117
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection End-Effector Robotic Training
    Comments Within group assessment for HADS Anxiety Subscale
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .041
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.75
    Confidence Interval (2-Sided) 95%
    .093 to 3.407
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy
    Comments Within group assessment for HADS Anxiety Subscale
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .150
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Combined group assessment of HADS Anxiety Subscale
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .012
    Comments p value adjusted for multiple comparisons
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.518
    Confidence Interval (2-Sided) 95%
    .390 to 2.646
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    7. Secondary Outcome
    Title Short Form McGill Pain Questionnaire
    Description Subjects completed a questionnaire evaluating their level of pain. There are 15 adjectives that describe the patient's pain. The patient ranks each of the words on a categoric scale of "none, mild, moderate, severe. Sensory and affective scores will be computed separately. Scores are created from a summary of the responses using an intensity scale of 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher the score the more severe the pain is for each of the subscales. For this study, sensory, affective, and total pain scores are reported. The minimum sensory, affective, and total score score would be zero. The maximum score for sensory is 33, affective is 12, and total is 45.
    Time Frame Subjects perception of the their pain will be assessed prior to the start of the treatment and following study completion (at 10 weeks)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Conventional Physical Therapy End-Effector Robotic Training
    Arm/Group Description Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases.13,14 The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence in stroke survivors. This system involves minimal therapist and patient burden (e.g., quick set-up, single operate usage), there is the unique capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
    Measure Participants 7 8
    Pretest Sensory Pain
    10.14
    (2.80)
    5.00
    (2.62)
    Posttest Sensory Pain
    8.29
    (2.88)
    5.38
    (2.70)
    Pretest Affective Pain
    2.57
    (.80)
    1.63
    (.74)
    Posttest Affective Pain
    2.29
    (1.22)
    1.88
    (1.15)
    Pretest Total Pain
    12.71
    (4.057)
    6.63
    (2.890)
    Posttest Total Pain
    11.14
    (4.114)
    7.25
    (4.057)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .239
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Comparison between groups for differences in sensory pain score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .667
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Between group differences in affective pain
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .770
    Comments
    Method ANOVA
    Comments
    8. Secondary Outcome
    Title Late-Life Disability Inventory (LLFDI)
    Description Subjects will complete a questionnaire evaluating their perceived level of disability. This tool assesses and responds to meaningful change in a persons disability (Ability to participate in life's activities). There is a 16 item disability component that is scored across two dimensions: frequency and limitation. Total scores and dimensional scores are created by summation and conversion to a 100 point scaled score. The instrument provides a table for converting the raw score to a scaled score. The lowest possible scale score is 0 and the highest score is 100 for both frequency and limitation. A higher score indicates greater functional ability and less disability. Each dimension can be further assessed by analyzing domains. There are social and personal domains within the frequency dimension and instrumental and management domains within the limitations dimension. All domains are calculated as described before through summation and scale adjustment.
    Time Frame Subjects perception of the their functional ability using the total score and dimensional scores will be assessed prior to the start of the treatment and following study completion (at 10 weeks)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Conventional Physical Therapy End-Effector Robotic Training
    Arm/Group Description Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases.13,14 The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence in stroke survivors. This system involves minimal therapist and patient burden (e.g., quick set-up, single operate usage), there is the unique capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
    Measure Participants 7 8
    LLFDI Frequency Pretest
    50.10
    (2.13)
    55.21
    (2.38)
    LLFDI Frequency Posttest
    49.78
    (2.74)
    54.93
    (2.57)
    LLFDI Limitations Pretest
    52.72
    (1.79)
    60.27
    (2.73)
    LLFDI Limitations Posttest
    56.00
    (2.78)
    62.44
    (2.99)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Between group assessment of LLFDI Disability Frequency
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .136
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Combined group assessment of improvement in LLFDI Disability Frequency
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .833
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Between Group Assessment of improvement in LLFDI Disability Limitations
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .044
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.996
    Confidence Interval (2-Sided) 95%
    .212 to 13.781
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Combined group assessment of improvement in LLFDI Disability Limitations
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .212
    Comments
    Method ANOVA
    Comments
    9. Secondary Outcome
    Title Late-Life Function Inventory
    Description Subjects will complete a questionnaire evaluating their perceived level of function. This tool assesses and responds to meaningful change in a persons function (ability to execute discrete tasks). There is a 32 item functional component is comprised of three domains Upper Extremity, Basic Lower Extremity, Advanced Lower Extremity. Total score and each domain will be scored by summing and then converting to a 100 point scaled score. The instrument provides a table for converting the raw score to a scaled score. A higher score indicates greater functional ability. The lowest score would be 0 and the highest scale score would be 100.
    Time Frame Subjects perception of the their functional ability using all three domains will be assessed prior to the start of the treatment and following study completion (at 10 weeks)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Conventional Physical Therapy End-Effector Robotic Training
    Arm/Group Description Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases.13,14 The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence in stroke survivors. This system involves minimal therapist and patient burden (e.g., quick set-up, single operate usage), there is the unique capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
    Measure Participants 7 8
    LLDFI Function Pretest
    43.65
    (1.51)
    45.76
    (2.96)
    LLFDI Function Posttest
    48.13
    (2.70)
    53.27
    (3.24)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Between group comparison for the LLDFI Function
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .338
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection End-Effector Robotic Training
    Comments Within group assessment of LLFDI Function
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .007
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 7.508
    Confidence Interval (2-Sided) 95%
    2.73 to 12.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy
    Comments Within group assessment for changes in LLFDI Function
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .067
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Conventional Physical Therapy, End-Effector Robotic Training
    Comments Combined group improvement in LLFDI Function
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .001
    Comments p value adjusted for multiple comparisons
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.99
    Confidence Interval (2-Sided) 95%
    2.90 to 9.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame 10 weeks
    Adverse Event Reporting Description
    Arm/Group Title Conventional Physical Therapy End-Effector Robotic Training
    Arm/Group Description Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute). G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases. The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence. This system has the capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
    All Cause Mortality
    Conventional Physical Therapy End-Effector Robotic Training
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/7 (0%) 0/8 (0%)
    Serious Adverse Events
    Conventional Physical Therapy End-Effector Robotic Training
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/7 (0%) 0/8 (0%)
    Other (Not Including Serious) Adverse Events
    Conventional Physical Therapy End-Effector Robotic Training
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/7 (0%) 0/8 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Peter Altenburger
    Organization Indiana University
    Phone 3172780703
    Email paltenbu@iu.edu
    Responsible Party:
    Peter Altenburger, Associate Professor, Health and Rehabilitation, Indiana University
    ClinicalTrials.gov Identifier:
    NCT03980145
    Other Study ID Numbers:
    • 1701909134
    First Posted:
    Jun 10, 2019
    Last Update Posted:
    Feb 14, 2022
    Last Verified:
    Jan 1, 2022