Robotically Assisted Treadmill Training in Spinal Cord Injury (SCI)

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00385918
• Collaborator: University of Maryland (Other), Kernan Orthopaedics and Rehabilitation Hospital (Other)
• Enrollment: 18
• Locations: 2
• Arms: 2
• Duration (Months): 56
• Patients Per Site: 9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This proposal investigates the hypothesis that progressive aerobic exercise with Lokomat is feasible in people with motor incomplete spinal cord injury, and three months of training will improve cardiovascular fitness and gait functionality when compared to physical therapy controls

Condition or Disease	Intervention/Treatment	Phase
Paraplegia; Quadriplegia; Spinal Cord Injury; Tetraplegia	Device: Lokomat Training; Other: Home stretching then Lokomat training	N/A

Detailed Description

Little information is available about the cardiovascular effects of robotically assisted partial weight support treadmill training devices such as Lokomat in chronic incomplete spinal cord injured subjects. Task-oriented aerobic exercise has the potential to improve both neuromuscular function and cardiovascular metabolic fitness in neurological populations. Since spinal cord injured individuals are at an increased risk of developing premature cardiovascular disease, the investigation of robotic-assisted interventions in spinal cord injury (SCI) such as the Lokomat may have important health benefits in both cardiovascular fitness as well as functional mobility.

This proposal investigates the hypothesis that progressive aerobic exercise with Lokomat is feasible in motor incomplete SCI, and three months of training will improve cardiovascular fitness and gait functionality when compared to physical therapy controls. We propose a two-phase study to examine the feasibility, reliability and utility of aerobic exercise metabolic testing and training during robotically assisted partial weight support treadmill walking in individuals with chronic motor incomplete spinal cord injury (CMISCI). During the first phase of the study we will manipulate Lokomat training parameters of treadmill speed and percent of partial weight support to assess the effect of these changes on heart rate, perceived exertion, and oxygen consumption in untrained chronic motor incomplete spinal cord injured subjects. Subjects will be asked to maintain cardiovascular or muscular effort during testing and will be monitored in this regard by the force biofeedback system built into the Lokomat. After determining threshold levels for initial cardiovascular response, submaximal and then peak exercise testing will be attempted. These studies will be repeated on a separate day to determine the reliability of the testing results. Thirty-six subjects with varying levels of injury between C4 and L2 and ASIA (American Spinal Injury) Impairment Scales of C and D will be recruited. We anticipate that subjects with greater ASIA motor scores will require either a faster initial treadmill speed or less partial weight support to produce an initial cardiovascular response. It is also anticipated that peak exercise testing using open circuit spirometry with subjects on the Lokomat will be a feasible, reliable and valid measurement. This phase of the study will be aimed at establishing guidelines for determining initial training parameters for use in an aerobic exercise protocol using the Lokomat.

The second phase of this pilot study will be a controlled trial of three-month progressive aerobic Lokomat exercise in chronic incomplete spinal cord injured subjects. The aim of this trial will be to determine whether progressive Lokomat training will improve cardiovascular fitness and ambulatory function when compared to matched impairment severity CMISCI subjects receiving the same duration of usual physical therapy care. Thirty-six subjects will be recruited into this phase of the study. Open spirometric evaluation of cardiovascular parameters as outlined in phase one of the proposal will be measured at baseline, 1 months, and 3 months. Initial, six-week and post-study ambulatory function evaluations including the WISCI (Walking Index for Spinal Cord Injury), a timed 10 meter walk, a measured walk over 6 minutes, and a gait analysis will also be determined. It is hypothesized that aerobic Lokomat exercise will improve cardiovascular fitness as determined by an increase in VO2 (oxygen consumption) peak and improve function as determined by timed walks and gait parameters in these subjects. The results of this pilot and development study will provide the necessary information to design larger randomized clinical trials.

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cardiovascular Parameters for Lokomat Training in Chronic Incomplete SCI
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lokomat training Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.	Device: Lokomat Training; The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.
Active Comparator: Home stretching then Lokomat training Patients will participate in a home stretching program for 3 months. They will then be crossed over to an active Lokomat treatment for a subsequent 3 months.	Other: Home stretching then Lokomat training; Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm. After 3 months the patients will be crossed over to Lokomat training for an additional 3 months. This training will be the same as given to the individuals originally randomized to the Lokomat treatment intervention.

Outcome Measures

Primary Outcome Measures

1. Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments [0, 1.5 and 3, 4.5, and 6 months]

   Peak V02 measurements taken during Lokomat exercise in order to measure cardiovascular fitness. Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.

2. Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments. [0, 1.5 and 3, 4.5, and 6 months]

   Peak oxygen consumption during arm cycle ergometry as a measure of cardiovascular fitness. Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.

Secondary Outcome Measures

1. Body Mass [Measured at Baseline (Time point 0), 3, and 6 months]

   DXA assessment of total body mass. Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.

2. Percent Body Fat [Measured at Baseline (Time point 0), 3, and 6 months]

   An assessment of percent body fat as determined by DXA analysis. Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.

3. Lean Muscle Mass [Measured at Baseline (Time point 0) and 3 months]

   DXA measurement of total lean muscle mass. Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.

4. Bone Mineral Content [Measured at Baseline (Time point 0), 3, and 6 months]

   DXA assessment of bone mineral content. Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.

5. Six Minute Walk [Measured Baseline (Time point 0) and 3 months]

   A functional capacity test to evaluate walking distance during a 6-minute time frame. This measure was only done on those participants that were able to walk for 6 minutes, which represented 9 in the Lokomat training group out of the 12 total randomized to Lokomat training, and 5 out of the 6 randomized to the home stretching group. Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.

6. 10-meter Walk [Measured at Baseline (Time point 0) and 3 months]

   A functional capacity test to measure speed. This measure was only done on those participants that were able to walk, which represented 9 in the Lokomat training group out of the 12 total randomized to Lokomat training, and 5 out of the 6 who were randomized to home stretching. Note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.

7. Step Activity Monitor [Measured at Baseline (Time point 0) and 3 months]

   The step activity monitor measures the total steps taken by an individual over a 48 hour time frame in the home environment. This measure was only done on those participants that were able to walk in the community and did not use a wheelchair for community mobility, which represented 7 in the Lokomat training group out of the 12 total randomized to Lokomat training and 5 out of 6 of the people randomized to home stretching. Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Acute onset Spinal Cord Injury or Disease at least 12 months prior to enrollment

• Age 18 to 80

• Level of injury from C4 to L2

• ASIA impairment scale either C or D

• Able to tolerate standing frame for at least 30 minutes

Exclusion Criteria:

• History of unstable angina, recent MI (myocardial infarction), CHF (congestive heart failure) or clinically significant valvular dysfunction

• History of recent hospitalization (<3 months) for a major medical problem

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Maryland Health Care System, Baltimore	Baltimore	Maryland	United States	21201
2	University of Maryland Rehabilitation and Orthopaedic Institute	Baltimore	Maryland	United States	21207

Sponsors and Collaborators

• US Department of Veterans Affairs
• University of Maryland
• Kernan Orthopaedics and Rehabilitation Hospital

Investigators

• Principal Investigator: Peter Gorman, MD MS, VA Maryland Health Care System, Baltimore

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Website of the manufacturer of the Lokomat

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00385918
• Other Study ID Numbers: B4027; B40271; HP-00042597
• First Posted: Oct 11, 2006
• Last Update Posted: May 14, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by US Department of Veterans Affairs: Cardiovascular Fitness; Exercise; Gait; Spinal Cord Injury; Treadmill Training
• Additional relevant MeSH terms: Spinal Cord Injuries; Paraplegia; Quadriplegia

Study Results

Participant Flow

Recruitment Details	Dates of recruitment: April 2007 through 2010. Location of recruitment: Kernan Hospital Spinal Cord Injury Clinic and Baltimore VAMC Spinal Cord Support Clinic.
Pre-assignment Detail	Participants all underwent baseline and feasibility testing prior to randomization in either of the two arms.

Arm/Group Title	Lokomat Training	Home Stretching Then Lokomat Training	Baseline and Feasibility Testing
Arm/Group Description	Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes. Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.	Patients will participate in a home stretching program for 3 months. Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm. After 3 months the participants will be switched to a 3 month period of Lokomat training the same as that offered to the patients randomized to the "Lokomat Training" arm of the study.	All subjects were screened and underwent baseline testing prior to randomization into either the Lokomat training or the Home stretching then Lokomat training group.
Period Title: Feasibility & Baseline Measurement Phase
STARTED	0	0	35
Number Eligible	0	0	27
Completed Baseline Tests	0	0	21
COMPLETED	0	0	21
NOT COMPLETED	0	0	14
Period Title: Feasibility & Baseline Measurement Phase
STARTED	15	6	0
COMPLETED	12	6	0
NOT COMPLETED	3	0	0

Baseline Characteristics

Arm/Group Title	Lokomat Exercise	Home Stretching Then Lokomat Exercise	Total
Arm/Group Description	Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes. Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.	Patients will participate in a home stretching program for 3 months. They will then be crossed over to Lokomat treatment for an additional 3 months. Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.	Total of all reporting groups
Overall Participants	12	6	18
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.5 (12.7)	52.0 (15.4)	51.7 (13.2)
Sex: Female, Male (Count of Participants)
Female	1 8.3%	0 0%	1 5.6%
Male	11 91.7%	6 100%	17 94.4%
Lower Extremity Motor Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	34.2 (11.5)	36.2 (8.4)	34.8 (10.3)
Body Mass (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	80.8 (14.6)	94.3 (25.0)	85.3 (19.1)
ASIA Impairment Scale (participants) [Number]
ASIA impairment C	2 16.7%	0 0%	2 11.1%
ASIA impairment D	10 83.3%	6 100%	16 88.9%
Impairment Function (participants) [Number]
Tetraplegia	8 66.7%	6 100%	14 77.8%
Paraplegia	4 33.3%	0 0%	4 22.2%

Outcome Measures

1. Primary Outcome

Title	Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments
Description	Peak V02 measurements taken during Lokomat exercise in order to measure cardiovascular fitness. Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.
Time Frame	0, 1.5 and 3, 4.5, and 6 months

Outcome Measure Data

Analysis Population Description

A single outlier point in the baseline data in one control subject was noted. Laboratory journal notes for this subject indicated that this individual had far more episodes of robotic treadmill stops during his baseline testing due to a high degree of spasticity. Given this, we felt justified in excluding this outlier from further data analysis.

Arm/Group Title	Lokomat Training	Home Stretching Then Lokomat Training
Arm/Group Description	Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes. Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.	Patients will participate in a home stretching program for 3 months. Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm. The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.
Measure Participants	12	6
Pre (time frame 0) VO2 peak	20.2 (7.4)	12.9 (4.4)
Midpoint (1.5 months) VO2 peak	22.5 (7.9)	11.6 (5.1)
Post_VO2 peak (3 months)	22.7 (7.5)	13.4 (3.9)
Home stretch group at 3 months pre Lokomat (n=6)	NA (NA)	18.7 (8.6)
Home stretch group VO2 peak midpoint (4.5 months)	NA (NA)	19.3 (8.4)
Home stretch group VO2 peak post (6 months)	NA (NA)	18.7 (7.0)

2. Secondary Outcome

Title	Body Mass
Description	DXA assessment of total body mass. Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.
Time Frame	Measured at Baseline (Time point 0), 3, and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lokomat Training	Home Stretching Then Lokomat Training
Arm/Group Description	Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes. Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.	Patients will participate in a home stretching program for 3 months. Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm. The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.
Measure Participants	12	6
Body Mass_Baseline	80.8 (14.6)	94.3 (25.0)
Body Mass_Post (3 months)	79.8 (15.0)	92.3 (23.3)
Home stretch group pre (3 months) Body mass	NA (NA)	93.4 (22.8)
Home stretch group post Body mass (6 months)	NA (NA)	94.8 (22.1)

3. Secondary Outcome

Title	Percent Body Fat
Description	An assessment of percent body fat as determined by DXA analysis. Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.
Time Frame	Measured at Baseline (Time point 0), 3, and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lokomat Training	Home Stretching Then Lokomat Training
Arm/Group Description	Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes. Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.	Patients will participate in a home stretching program for 3 months. Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm. The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.
Measure Participants	12	6
Percent Body Fat_Baseline (time 0)	33.6 (7.9)	34.2 (6.9)
Percent Body Fat_Post (3 months)	32.4 (7.7)	33.3 (7.4)
Home stretch group pre %Body fat (3 months)	NA (NA)	33.3 (7.2)
Home stretch group post %Body fat (6 months)	NA (NA)	33.7 (6.4)

4. Primary Outcome

Title	Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments.
Description	Peak oxygen consumption during arm cycle ergometry as a measure of cardiovascular fitness. Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.
Time Frame	0, 1.5 and 3, 4.5, and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lokomat Treatment	Home Stretching Then Lokomat Training
Arm/Group Description	Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes. Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.	Patients will participate in a home stretching program for 3 months. Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm. The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.
Measure Participants	12	6
Pre (time frame 0) VO2 peak arm ergometry	20.0 (6.5)	13.5 (3.3)
Midpoint (1.5 months) VO2 peak arm ergometry	19.8 (5.4)	11.1 (2.1)
Post (3 months) VO2 peak arm ergometry	21.7 (7.5)	13.7 (2.5)
Home stretch group (3 months) pre Lokomat training	NA (NA)	13.2 (2.9)
Home stretch group midpoint (4.5 m) Lokomat	NA (NA)	12.3 (5.0)
Home stretch group post Lokomat (6 mod)	NA (NA)	13.0 (4.1)

5. Secondary Outcome

Title	Lean Muscle Mass
Description	DXA measurement of total lean muscle mass. Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.
Time Frame	Measured at Baseline (Time point 0) and 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lokomat Training	Home Stretching Then Lokomat Training
Arm/Group Description	Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes. Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.	Patients will participate in a home stretching program for 3 months. Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm. The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.
Measure Participants	12	6
Lean Muscle Mass_Baseline (0 months)	51.2 (8.5)	58.9 (11.3)
Lean Muscle Mass_Post (3 months)	51.4 (8.0)	58.3 (9.6)
Home stretch Group Pre Lean Muscle Mass (3 months)	NA (NA)	59.0 (9.5)
Home muscle Group Post Lean Muscle Mass (6 months)	NA (NA)	59.9 (10.2)

6. Secondary Outcome

Title	Bone Mineral Content
Description	DXA assessment of bone mineral content. Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.
Time Frame	Measured at Baseline (Time point 0), 3, and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lokomat Training	Home Stretching Then Lokomat Training
Arm/Group Description	Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes. Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.	Patients will participate in a home stretching program for 3 months. Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm. The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.
Measure Participants	12	6
Bone Mineral Content_Baseline (0 months)	3.04 (0.46)	3.18 (0.46)
Bone Mineral Content_Post (3 months)	3.02 (0.44)	3.16 (0.55)
Home stretch Pre Bone Mineral Content (3 months)	NA (NA)	3.17 (0.56)
Home stretch Post Bone Mineral Content (6 months)	NA (NA)	3.15 (0.50)

7. Secondary Outcome

Title	Six Minute Walk
Description	A functional capacity test to evaluate walking distance during a 6-minute time frame. This measure was only done on those participants that were able to walk for 6 minutes, which represented 9 in the Lokomat training group out of the 12 total randomized to Lokomat training, and 5 out of the 6 randomized to the home stretching group. Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.
Time Frame	Measured Baseline (Time point 0) and 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lokomat Training	Home Stretching Then Lokomat Training
Arm/Group Description	Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes. Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.	Patients will participate in a home stretching program for 3 months. Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm. The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.
Measure Participants	9	5
Six-minute Walk_Baseline (0 months)	179.5 (76.4)	203.0 (108.3)
Six-minute Walk_Post (3 months)	201.6 (94.6)	250.8 (136.3)

8. Secondary Outcome

Title	10-meter Walk
Description	A functional capacity test to measure speed. This measure was only done on those participants that were able to walk, which represented 9 in the Lokomat training group out of the 12 total randomized to Lokomat training, and 5 out of the 6 who were randomized to home stretching. Note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.
Time Frame	Measured at Baseline (Time point 0) and 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lokomat Training	Home Stretching Then Lokomat Training
Arm/Group Description	Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes. Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.	Patients will participate in a home stretching program for 3 months. Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm. The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.
Measure Participants	9	5
10-meter walk_Baseline (0 months)	23.0 (17.5)	16.5 (7.6)
10-meter walk_post (3 months)	21.3 (17.8)	14.6 (7.1)

9. Secondary Outcome

Title	Step Activity Monitor
Description	The step activity monitor measures the total steps taken by an individual over a 48 hour time frame in the home environment. This measure was only done on those participants that were able to walk in the community and did not use a wheelchair for community mobility, which represented 7 in the Lokomat training group out of the 12 total randomized to Lokomat training and 5 out of 6 of the people randomized to home stretching. Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.
Time Frame	Measured at Baseline (Time point 0) and 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lokomat Training	Home Stretching Then Lokomat Training
Arm/Group Description	Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes. Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.	Patients will participate in a home stretching program for 3 months. Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm. The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.
Measure Participants	7	5
Average 24-hour step total_Baseline (0 months)	1674.8 (1129.1)	1531.3 (1576.2)
Average 24-hour step total_Post (3 months)	1579.9 (1078.4)	1652.4 (1707.1)

Adverse Events

Arm/Group Title	Lokomat Training		Home Stretching Then Lokomat Training
Arm/Group Description	Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes. Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.		Patients will participate in a home stretching program for 3 months. Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.This group will switch to the 3-month robotic intervention after completing the home-based training program.
All Cause Mortality
	Lokomat Training		Home Stretching Then Lokomat Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lokomat Training		Home Stretching Then Lokomat Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/15 (6.7%)		0/6 (0%)
Cardiac disorders
Chest and Abdominal Pain	1/15 (6.7%)	1	0/6 (0%)	0
Other (Not Including Serious) Adverse Events
	Lokomat Training		Home Stretching Then Lokomat Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/15 (33.3%)		3/6 (50%)
General disorders
General pain and lethargy	1/15 (6.7%)	1	1/6 (16.7%)	1
Hypotensive response	1/15 (6.7%)	1	0/6 (0%)	0
Significant Weight Loss	0/15 (0%)	0	1/6 (16.7%)	1
Musculoskeletal and connective tissue disorders
Bruise	1/15 (6.7%)	2	0/6 (0%)	0
Ankle Swelling	1/15 (6.7%)	1	0/6 (0%)	0
Renal and urinary disorders
Urinary Tract Infection (UTI)	0/15 (0%)	0	1/6 (16.7%)	2
Blood in urine	1/15 (6.7%)	1	0/6 (0%)	0
Skin and subcutaneous tissue disorders
Skin abrasion	2/15 (13.3%)	3	0/6 (0%)	0

Limitations/Caveats

Skin irritation caused missed sessions. Attendance rates were lower than desired given medical and transportation factors. No clearly defined exclusion criteria for bone density in individuals with SCI using this type intervention.

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.