G-EO Gait Rehabilitation Training in Progressive Multiple Sclerosis
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 |
---|---|---|
|
N/A |
Study Design
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:
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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
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.- 1701909134
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
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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
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 |
paltenbu@iu.edu |
- 1701909134