Trial Outcomes & Findings for Robotically Assisted Treadmill Training in Spinal Cord Injury (SCI) (NCT NCT00385918)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

0, 1.5 and 3, 4.5, and 6 months

Results posted on

2014-05-14

Participant Flow

Dates of recruitment: April 2007 through 2010. Location of recruitment: Kernan Hospital Spinal Cord Injury Clinic and Baltimore VAMC Spinal Cord Support Clinic.

Participants all underwent baseline and feasibility testing prior to randomization in either of the two arms.

Participant milestones

Participant milestones
Measure	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. 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.	Home Stretching Then Lokomat Training 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.	Baseline and Feasibility Testing All subjects were screened and underwent baseline testing prior to randomization into either the Lokomat training or the Home stretching then Lokomat training group.
Feasibility & Baseline Measurement Phase STARTED	0	0	35
Feasibility & Baseline Measurement Phase Number Eligible	0	0	27
Feasibility & Baseline Measurement Phase Completed Baseline Tests	0	0	21
Feasibility & Baseline Measurement Phase COMPLETED	0	0	21
Feasibility & Baseline Measurement Phase NOT COMPLETED	0	0	14
Intervention Phase After Randomization STARTED	15	6	0
Intervention Phase After Randomization COMPLETED	12	6	0
Intervention Phase After Randomization NOT COMPLETED	3	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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.	Baseline and Feasibility Testing All subjects were screened and underwent baseline testing prior to randomization into either the Lokomat training or the Home stretching then Lokomat training group.
Feasibility & Baseline Measurement Phase outside of inclusion criteria	0	8
Feasibility & Baseline Measurement Phase Withdrawal by Subject	0	5
Feasibility & Baseline Measurement Phase Physician Decision	0	1
Intervention Phase After Randomization Withdrawal by Subject	1	0
Intervention Phase After Randomization Physician Decision	1	0
Intervention Phase After Randomization Lost to Follow-up	1	0

Baseline Characteristics

Robotically Assisted Treadmill Training in Spinal Cord Injury (SCI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lokomat Exercise n=12 Participants 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.	Home Stretching Then Lokomat Exercise n=6 Participants 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 n=18 Participants Total of all reporting groups
Age, Continuous	51.5 years STANDARD_DEVIATION 12.7 • n=5 Participants	52.0 years STANDARD_DEVIATION 15.4 • n=7 Participants	51.7 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Lower Extremity Motor Score	34.2 units on a scale STANDARD_DEVIATION 11.5 • n=5 Participants	36.2 units on a scale STANDARD_DEVIATION 8.4 • n=7 Participants	34.8 units on a scale STANDARD_DEVIATION 10.3 • n=5 Participants
Body Mass	80.8 kg STANDARD_DEVIATION 14.6 • n=5 Participants	94.3 kg STANDARD_DEVIATION 25.0 • n=7 Participants	85.3 kg STANDARD_DEVIATION 19.1 • n=5 Participants
ASIA Impairment Scale ASIA impairment C	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
ASIA Impairment Scale ASIA impairment D	10 participants n=5 Participants	6 participants n=7 Participants	16 participants n=5 Participants
Impairment Function Tetraplegia	8 participants n=5 Participants	6 participants n=7 Participants	14 participants n=5 Participants
Impairment Function Paraplegia	4 participants n=5 Participants	0 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 0, 1.5 and 3, 4.5, and 6 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Lokomat Training n=12 Participants 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.	Home Stretching Then Lokomat Training n=6 Participants 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.
Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments Pre (time frame 0) VO2 peak	20.2 ml/kg/min Standard Deviation 7.4	12.9 ml/kg/min Standard Deviation 4.4
Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments Midpoint (1.5 months) VO2 peak	22.5 ml/kg/min Standard Deviation 7.9	11.6 ml/kg/min Standard Deviation 5.1
Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments Post_VO2 peak (3 months)	22.7 ml/kg/min Standard Deviation 7.5	13.4 ml/kg/min Standard Deviation 3.9
Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments Home stretch group at 3 months pre Lokomat (n=6)	NA ml/kg/min Standard Deviation NA Treatment completed	18.7 ml/kg/min Standard Deviation 8.6
Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments Home stretch group VO2 peak midpoint (4.5 months)	NA ml/kg/min Standard Deviation NA Treatment completed	19.3 ml/kg/min Standard Deviation 8.4
Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments Home stretch group VO2 peak post (6 months)	NA ml/kg/min Standard Deviation NA Treatment completed	18.7 ml/kg/min Standard Deviation 7.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lokomat Training n=12 Participants 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.	Home Stretching Then Lokomat Training n=6 Participants 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.
Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments. Pre (time frame 0) VO2 peak arm ergometry	20.0 ml/kg/min Standard Deviation 6.5	13.5 ml/kg/min Standard Deviation 3.3
Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments. Midpoint (1.5 months) VO2 peak arm ergometry	19.8 ml/kg/min Standard Deviation 5.4	11.1 ml/kg/min Standard Deviation 2.1
Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments. Post (3 months) VO2 peak arm ergometry	21.7 ml/kg/min Standard Deviation 7.5	13.7 ml/kg/min Standard Deviation 2.5
Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments. Home stretch group (3 months) pre Lokomat training	NA ml/kg/min Standard Deviation NA Treatment completed	13.2 ml/kg/min Standard Deviation 2.9
Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments. Home stretch group midpoint (4.5 m) Lokomat	NA ml/kg/min Standard Deviation NA Treatment completed	12.3 ml/kg/min Standard Deviation 5.0
Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments. Home stretch group post Lokomat (6 mod)	NA ml/kg/min Standard Deviation NA treatment completed	13.0 ml/kg/min Standard Deviation 4.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lokomat Training n=12 Participants 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.	Home Stretching Then Lokomat Training n=6 Participants 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.
Body Mass Body Mass_Baseline	80.8 kg Standard Deviation 14.6	94.3 kg Standard Deviation 25.0
Body Mass Body Mass_Post (3 months)	79.8 kg Standard Deviation 15.0	92.3 kg Standard Deviation 23.3
Body Mass Home stretch group pre (3 months) Body mass	NA kg Standard Deviation NA Treatment completed	93.4 kg Standard Deviation 22.8
Body Mass Home stretch group post Body mass (6 months)	NA kg Standard Deviation NA Treatment completed	94.8 kg Standard Deviation 22.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lokomat Training n=12 Participants 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.	Home Stretching Then Lokomat Training n=6 Participants 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.
Percent Body Fat Home stretch group post %Body fat (6 months)	NA percent of total mass Standard Deviation NA Treatment completed	33.7 percent of total mass Standard Deviation 6.4
Percent Body Fat Percent Body Fat_Baseline (time 0)	33.6 percent of total mass Standard Deviation 7.9	34.2 percent of total mass Standard Deviation 6.9
Percent Body Fat Percent Body Fat_Post (3 months)	32.4 percent of total mass Standard Deviation 7.7	33.3 percent of total mass Standard Deviation 7.4
Percent Body Fat Home stretch group pre %Body fat (3 months)	NA percent of total mass Standard Deviation NA Treatment completed	33.3 percent of total mass Standard Deviation 7.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lokomat Training n=12 Participants 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.	Home Stretching Then Lokomat Training n=6 Participants 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.
Lean Muscle Mass Lean Muscle Mass_Baseline (0 months)	51.2 kg Standard Deviation 8.5	58.9 kg Standard Deviation 11.3
Lean Muscle Mass Lean Muscle Mass_Post (3 months)	51.4 kg Standard Deviation 8.0	58.3 kg Standard Deviation 9.6
Lean Muscle Mass Home stretch Group Pre Lean Muscle Mass (3 months)	NA kg Standard Deviation NA Treatment completed	59.0 kg Standard Deviation 9.5
Lean Muscle Mass Home muscle Group Post Lean Muscle Mass (6 months)	NA kg Standard Deviation NA Treatment completed	59.9 kg Standard Deviation 10.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lokomat Training n=12 Participants 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.	Home Stretching Then Lokomat Training n=6 Participants 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.
Bone Mineral Content Bone Mineral Content_Baseline (0 months)	3.04 kg Standard Deviation 0.46	3.18 kg Standard Deviation 0.46
Bone Mineral Content Bone Mineral Content_Post (3 months)	3.02 kg Standard Deviation 0.44	3.16 kg Standard Deviation 0.55
Bone Mineral Content Home stretch Pre Bone Mineral Content (3 months)	NA kg Standard Deviation NA Treatment completed	3.17 kg Standard Deviation 0.56
Bone Mineral Content Home stretch Post Bone Mineral Content (6 months)	NA kg Standard Deviation NA Treatment completed	3.15 kg Standard Deviation 0.50

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lokomat Training n=9 Participants 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.	Home Stretching Then Lokomat Training n=5 Participants 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.
Six Minute Walk Six-minute Walk_Baseline (0 months)	179.5 meters Standard Deviation 76.4	203.0 meters Standard Deviation 108.3
Six Minute Walk Six-minute Walk_Post (3 months)	201.6 meters Standard Deviation 94.6	250.8 meters Standard Deviation 136.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lokomat Training n=9 Participants 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.	Home Stretching Then Lokomat Training n=5 Participants 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.
10-meter Walk 10-meter walk_Baseline (0 months)	23.0 seconds Standard Deviation 17.5	16.5 seconds Standard Deviation 7.6
10-meter Walk 10-meter walk_post (3 months)	21.3 seconds Standard Deviation 17.8	14.6 seconds Standard Deviation 7.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lokomat Training n=7 Participants 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.	Home Stretching Then Lokomat Training n=5 Participants 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.
Step Activity Monitor Average 24-hour step total_Baseline (0 months)	1674.8 steps Standard Deviation 1129.1	1531.3 steps Standard Deviation 1576.2
Step Activity Monitor Average 24-hour step total_Post (3 months)	1579.9 steps Standard Deviation 1078.4	1652.4 steps Standard Deviation 1707.1

Adverse Events

Lokomat Training

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Home Stretching Then Lokomat Training

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lokomat Training n=15 participants at risk 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.	Home Stretching Then Lokomat Training n=6 participants at risk 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.
Cardiac disorders Chest and Abdominal Pain	6.7% 1/15 • Number of events 1	0.00% 0/6

Other adverse events

Other adverse events
Measure	Lokomat Training n=15 participants at risk 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.	Home Stretching Then Lokomat Training n=6 participants at risk 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.
Skin and subcutaneous tissue disorders Skin abrasion	13.3% 2/15 • Number of events 3	0.00% 0/6
Renal and urinary disorders Urinary Tract Infection (UTI)	0.00% 0/15	16.7% 1/6 • Number of events 2
Musculoskeletal and connective tissue disorders Bruise	6.7% 1/15 • Number of events 2	0.00% 0/6
General disorders General pain and lethargy	6.7% 1/15 • Number of events 1	16.7% 1/6 • Number of events 1
Renal and urinary disorders Blood in urine	6.7% 1/15 • Number of events 1	0.00% 0/6
General disorders Hypotensive response	6.7% 1/15 • Number of events 1	0.00% 0/6
General disorders Significant Weight Loss	0.00% 0/15	16.7% 1/6 • Number of events 1
Musculoskeletal and connective tissue disorders Ankle Swelling	6.7% 1/15 • Number of events 1	0.00% 0/6

Additional Information

Peter H. Gorman, MD Chief Division of Rehabilitation Medicine

University of Maryland Rehabiitation and Orthopaedic Institute

Phone: 410-448-6261

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place