Paraplegia, Quadriplegia, Spinal Cord Injury, Tetraplegia
Conditions
Keywords
Cardiovascular Fitness, Exercise, Gait, Spinal Cord Injury, Treadmill Training
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
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.
Interventions
DEVICELokomat 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.
OTHERHome 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.
Sponsors
University of Maryland
Kernan Orthopaedics and Rehabilitation Hospital
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
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 details
Participants all underwent baseline and feasibility testing prior to randomization in either of the two arms.
Participants by arm
| Arm | Count |
|---|---|
| Lokomat Exercise 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. | 12 |
| Home Stretching Then Lokomat Exercise 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. | 6 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Feasibility & Baseline Measurement Phase | outside of inclusion criteria | 0 | 0 | 8 |
| Feasibility & Baseline Measurement Phase | Physician Decision | 0 | 0 | 1 |
| Feasibility & Baseline Measurement Phase | Withdrawal by Subject | 0 | 0 | 5 |
| Intervention Phase After Randomization | Lost to Follow-up | 1 | 0 | 0 |
| Intervention Phase After Randomization | Physician Decision | 1 | 0 | 0 |
| Intervention Phase After Randomization | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Lokomat Exercise | Home Stretching Then Lokomat Exercise | Total |
|---|---|---|---|
| Age, Continuous | 51.5 years STANDARD_DEVIATION 12.7 | 52.0 years STANDARD_DEVIATION 15.4 | 51.7 years STANDARD_DEVIATION 13.2 |
| ASIA Impairment Scale ASIA impairment C | 2 participants | 0 participants | 2 participants |
| ASIA Impairment Scale ASIA impairment D | 10 participants | 6 participants | 16 participants |
| Body Mass | 80.8 kg STANDARD_DEVIATION 14.6 | 94.3 kg STANDARD_DEVIATION 25 | 85.3 kg STANDARD_DEVIATION 19.1 |
| Impairment Function Paraplegia | 4 participants | 0 participants | 4 participants |
| Impairment Function Tetraplegia | 8 participants | 6 participants | 14 participants |
| Lower Extremity Motor Score | 34.2 units on a scale STANDARD_DEVIATION 11.5 | 36.2 units on a scale STANDARD_DEVIATION 8.4 | 34.8 units on a scale STANDARD_DEVIATION 10.3 |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 11 Participants | 6 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 15 | 3 / 6 |
| serious Total, serious adverse events | 1 / 15 | 0 / 6 |
Outcome results
Primary
Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments.
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lokomat Training | 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 |
| Lokomat Training | 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 |
| Lokomat Training | 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 |
| Lokomat Training | Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments. | Home stretch group (3 months) pre Lokomat training | NA ml/kg/min | — |
| Lokomat Training | Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments. | Home stretch group midpoint (4.5 m) Lokomat | NA ml/kg/min | — |
| Lokomat Training | Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments. | Home stretch group post Lokomat (6 mod) | NA ml/kg/min | — |
| Home Stretching Then Lokomat Training | Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments. | Home stretch group midpoint (4.5 m) Lokomat | 12.3 ml/kg/min | Standard Deviation 5 |
| Home Stretching Then Lokomat Training | Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments. | Pre (time frame 0) VO2 peak arm ergometry | 13.5 ml/kg/min | Standard Deviation 3.3 |
| Home Stretching Then Lokomat Training | Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments. | Home stretch group (3 months) pre Lokomat training | 13.2 ml/kg/min | Standard Deviation 2.9 |
| Home Stretching Then Lokomat Training | Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments. | Midpoint (1.5 months) VO2 peak arm ergometry | 11.1 ml/kg/min | Standard Deviation 2.1 |
| Home Stretching Then Lokomat Training | Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments. | Home stretch group post Lokomat (6 mod) | 13.0 ml/kg/min | Standard Deviation 4.1 |
| Home Stretching Then Lokomat Training | Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments. | Post (3 months) VO2 peak arm ergometry | 13.7 ml/kg/min | Standard Deviation 2.5 |
Primary
Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lokomat Training | Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments | Pre (time frame 0) VO2 peak | 20.2 ml/kg/min | Standard Deviation 7.4 |
| Lokomat Training | Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments | Midpoint (1.5 months) VO2 peak | 22.5 ml/kg/min | Standard Deviation 7.9 |
| Lokomat Training | Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments | Post_VO2 peak (3 months) | 22.7 ml/kg/min | Standard Deviation 7.5 |
| Lokomat Training | Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments | Home stretch group at 3 months pre Lokomat (n=6) | NA ml/kg/min | — |
| Lokomat Training | Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments | Home stretch group VO2 peak midpoint (4.5 months) | NA ml/kg/min | — |
| Lokomat Training | Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments | Home stretch group VO2 peak post (6 months) | NA ml/kg/min | — |
| Home Stretching Then Lokomat Training | Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments | Home stretch group VO2 peak midpoint (4.5 months) | 19.3 ml/kg/min | Standard Deviation 8.4 |
| Home Stretching Then Lokomat Training | Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments | Pre (time frame 0) VO2 peak | 12.9 ml/kg/min | Standard Deviation 4.4 |
| Home Stretching Then Lokomat Training | Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments | Home stretch group at 3 months pre Lokomat (n=6) | 18.7 ml/kg/min | Standard Deviation 8.6 |
| Home Stretching Then Lokomat Training | Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments | Midpoint (1.5 months) VO2 peak | 11.6 ml/kg/min | Standard Deviation 5.1 |
| Home Stretching Then Lokomat Training | Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments | Home stretch group VO2 peak post (6 months) | 18.7 ml/kg/min | Standard Deviation 7 |
| Home Stretching Then Lokomat Training | Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments | Post_VO2 peak (3 months) | 13.4 ml/kg/min | Standard Deviation 3.9 |
Secondary
10-meter Walk
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lokomat Training | 10-meter Walk | 10-meter walk_Baseline (0 months) | 23.0 seconds | Standard Deviation 17.5 |
| Lokomat Training | 10-meter Walk | 10-meter walk_post (3 months) | 21.3 seconds | Standard Deviation 17.8 |
| Home Stretching Then Lokomat Training | 10-meter Walk | 10-meter walk_Baseline (0 months) | 16.5 seconds | Standard Deviation 7.6 |
| Home Stretching Then Lokomat Training | 10-meter Walk | 10-meter walk_post (3 months) | 14.6 seconds | Standard Deviation 7.1 |
Secondary
Body Mass
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lokomat Training | Body Mass | Body Mass_Baseline | 80.8 kg | Standard Deviation 14.6 |
| Lokomat Training | Body Mass | Body Mass_Post (3 months) | 79.8 kg | Standard Deviation 15 |
| Lokomat Training | Body Mass | Home stretch group pre (3 months) Body mass | NA kg | — |
| Lokomat Training | Body Mass | Home stretch group post Body mass (6 months) | NA kg | — |
| Home Stretching Then Lokomat Training | Body Mass | Home stretch group post Body mass (6 months) | 94.8 kg | Standard Deviation 22.1 |
| Home Stretching Then Lokomat Training | Body Mass | Body Mass_Baseline | 94.3 kg | Standard Deviation 25 |
| Home Stretching Then Lokomat Training | Body Mass | Home stretch group pre (3 months) Body mass | 93.4 kg | Standard Deviation 22.8 |
| Home Stretching Then Lokomat Training | Body Mass | Body Mass_Post (3 months) | 92.3 kg | Standard Deviation 23.3 |
Secondary
Bone Mineral Content
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lokomat Training | Bone Mineral Content | Bone Mineral Content_Baseline (0 months) | 3.04 kg | Standard Deviation 0.46 |
| Lokomat Training | Bone Mineral Content | Bone Mineral Content_Post (3 months) | 3.02 kg | Standard Deviation 0.44 |
| Lokomat Training | Bone Mineral Content | Home stretch Pre Bone Mineral Content (3 months) | NA kg | — |
| Lokomat Training | Bone Mineral Content | Home stretch Post Bone Mineral Content (6 months) | NA kg | — |
| Home Stretching Then Lokomat Training | Bone Mineral Content | Home stretch Post Bone Mineral Content (6 months) | 3.15 kg | Standard Deviation 0.5 |
| Home Stretching Then Lokomat Training | Bone Mineral Content | Bone Mineral Content_Baseline (0 months) | 3.18 kg | Standard Deviation 0.46 |
| Home Stretching Then Lokomat Training | Bone Mineral Content | Home stretch Pre Bone Mineral Content (3 months) | 3.17 kg | Standard Deviation 0.56 |
| Home Stretching Then Lokomat Training | Bone Mineral Content | Bone Mineral Content_Post (3 months) | 3.16 kg | Standard Deviation 0.55 |
Secondary
Lean Muscle Mass
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lokomat Training | Lean Muscle Mass | Home stretch Group Pre Lean Muscle Mass (3 months) | NA kg | — |
| Lokomat Training | Lean Muscle Mass | Lean Muscle Mass_Baseline (0 months) | 51.2 kg | Standard Deviation 8.5 |
| Lokomat Training | Lean Muscle Mass | Home muscle Group Post Lean Muscle Mass (6 months) | NA kg | — |
| Lokomat Training | Lean Muscle Mass | Lean Muscle Mass_Post (3 months) | 51.4 kg | Standard Deviation 8 |
| Home Stretching Then Lokomat Training | Lean Muscle Mass | Home muscle Group Post Lean Muscle Mass (6 months) | 59.9 kg | Standard Deviation 10.2 |
| Home Stretching Then Lokomat Training | Lean Muscle Mass | Lean Muscle Mass_Baseline (0 months) | 58.9 kg | Standard Deviation 11.3 |
| Home Stretching Then Lokomat Training | Lean Muscle Mass | Home stretch Group Pre Lean Muscle Mass (3 months) | 59.0 kg | Standard Deviation 9.5 |
| Home Stretching Then Lokomat Training | Lean Muscle Mass | Lean Muscle Mass_Post (3 months) | 58.3 kg | Standard Deviation 9.6 |
Secondary
Percent Body Fat
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lokomat Training | Percent Body Fat | Percent Body Fat_Baseline (time 0) | 33.6 percent of total mass | Standard Deviation 7.9 |
| Lokomat Training | Percent Body Fat | Percent Body Fat_Post (3 months) | 32.4 percent of total mass | Standard Deviation 7.7 |
| Lokomat Training | Percent Body Fat | Home stretch group pre %Body fat (3 months) | NA percent of total mass | — |
| Lokomat Training | Percent Body Fat | Home stretch group post %Body fat (6 months) | NA percent of total mass | — |
| Home Stretching Then Lokomat Training | Percent Body Fat | Home stretch group post %Body fat (6 months) | 33.7 percent of total mass | Standard Deviation 6.4 |
| Home Stretching Then Lokomat Training | Percent Body Fat | Percent Body Fat_Baseline (time 0) | 34.2 percent of total mass | Standard Deviation 6.9 |
| Home Stretching Then Lokomat Training | Percent Body Fat | Home stretch group pre %Body fat (3 months) | 33.3 percent of total mass | Standard Deviation 7.2 |
| Home Stretching Then Lokomat Training | Percent Body Fat | Percent Body Fat_Post (3 months) | 33.3 percent of total mass | Standard Deviation 7.4 |
Secondary
Six Minute Walk
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lokomat Training | Six Minute Walk | Six-minute Walk_Baseline (0 months) | 179.5 meters | Standard Deviation 76.4 |
| Lokomat Training | Six Minute Walk | Six-minute Walk_Post (3 months) | 201.6 meters | Standard Deviation 94.6 |
| Home Stretching Then Lokomat Training | Six Minute Walk | Six-minute Walk_Baseline (0 months) | 203.0 meters | Standard Deviation 108.3 |
| Home Stretching Then Lokomat Training | Six Minute Walk | Six-minute Walk_Post (3 months) | 250.8 meters | Standard Deviation 136.3 |
Secondary
Step Activity Monitor
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lokomat Training | Step Activity Monitor | Average 24-hour step total_Post (3 months) | 1579.9 steps | Standard Deviation 1078.4 |
| Lokomat Training | Step Activity Monitor | Average 24-hour step total_Baseline (0 months) | 1674.8 steps | Standard Deviation 1129.1 |
| Home Stretching Then Lokomat Training | Step Activity Monitor | Average 24-hour step total_Post (3 months) | 1652.4 steps | Standard Deviation 1707.1 |
| Home Stretching Then Lokomat Training | Step Activity Monitor | Average 24-hour step total_Baseline (0 months) | 1531.3 steps | Standard Deviation 1576.2 |