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| ID | Type | Description | Link |
|---|---|---|---|
| B40271 | Other Identifier | UMB-IRB old BRAAN system | |
| HP-00042597 | Other Identifier | UMB-IRB |
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| Name | Class |
|---|---|
| University of Maryland | OTHER |
| Kernan Orthopaedics and Rehabilitation Hospital | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lokomat training | Experimental | Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes. |
|
| Home stretching then Lokomat training | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lokomat Training | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0, 1.5 and 3, 4.5, and 6 months |
| 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. | 0, 1.5 and 3, 4.5, and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Gorman, MD MS | VA Maryland Health Care System, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Maryland Health Care System, Baltimore | Baltimore | Maryland | 21201 | United States | ||
| University of Maryland Rehabilitation and Orthopaedic Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24534779 | Result | Gorman PH, Geigle PR, Chen K, York H, Scott W. Reliability and relatedness of peak VO2 assessments during body weight supported treadmill training and arm cycle ergometry in individuals with chronic motor incomplete spinal cord injury. Spinal Cord. 2014 Apr;52(4):287-91. doi: 10.1038/sc.2014.6. Epub 2014 Feb 18. | |
| 25520035 | Derived |
| Label | URL |
|---|---|
| Hospital where the research is being undertaken. | View source |
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Participants all underwent baseline and feasibility testing prior to randomization in either of the two arms.
Dates of recruitment: April 2007 through 2010. Location of recruitment: Kernan Hospital Spinal Cord Injury Clinic and Baltimore VAMC Spinal Cord Support Clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Feasibility & Baseline Measurement Phase |
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| Intervention Phase After Randomization |
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The baseline analysis includes data from individuals who have completed the 3-month robotic and home-base interventions
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | ml/kg/min | 0, 1.5 and 3, 4.5, and 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest and Abdominal Pain | Cardiac disorders | Systematic Assessment | EKG was not consistent with cardiac ischemia. The subject was excluded from further exercise until he was able to undergo a thallium stress test, which did not reveal any ischemic cardiovascular disease |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin abrasion | Skin and subcutaneous tissue disorders | Systematic Assessment | Participants experienced skin abrasions in several areas due to the parachute harness. The following areas were affected: scrotum, scapulae, leg, axilla, chest, shoulder, and groin |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter H. Gorman, MD Chief Division of Rehabilitation Medicine | University of Maryland Rehabiitation and Orthopaedic Institute | 410-448-6261 | pgorman@umm.edu |
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| ID | Term |
|---|---|
| D010264 | Paraplegia |
| D011782 | Quadriplegia |
| D013119 | Spinal Cord Injuries |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| Home stretching then Lokomat training | Other | 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. |
|
| Measured at Baseline (Time point 0), 3, and 6 months |
| 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. | Measured at Baseline (Time point 0), 3, and 6 months |
| 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. | Measured at Baseline (Time point 0) and 3 months |
| 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. | Measured at Baseline (Time point 0), 3, and 6 months |
| 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. | Measured Baseline (Time point 0) and 3 months |
| 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. | Measured at Baseline (Time point 0) and 3 months |
| 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. | Measured at Baseline (Time point 0) and 3 months |
| Baltimore |
| Maryland |
| 21207 |
| United States |
| Gorman PH, Scott W, York H, Theyagaraj M, Price-Miller N, McQuaid J, Eyvazzadeh M, Ivey FM, Macko RF. Robotically assisted treadmill exercise training for improving peak fitness in chronic motor incomplete spinal cord injury: A randomized controlled trial. J Spinal Cord Med. 2016;39(1):32-44. doi: 10.1179/2045772314Y.0000000281. Epub 2014 Dec 18. |
| Physician Decision |
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| NOT COMPLETED |
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| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Lower Extremity Motor Score | The motor score assigned to the five key bi-lateral lower extremity muscle groups with values ranging from 0 (total paralysis) to 5 (normal) function for each muscle. Because 10 muscles are being tested (5 in each leg), the total possible motor score is 50. | Mean | Standard Deviation | units on a scale |
|
| Body Mass | Body mass was determined from a DXA (dual energy x-ray absorptiometry) assessment prior to the 3-month intervention. | Mean | Standard Deviation | kg |
|
| ASIA Impairment Scale | American Spinal Injury Association (ASIA) Impairment Scale is used to grade the degree of sensory & motor impairment. ASIA impairment scale C- motor function preserved below the neurological level with > half of the key muscles below the neurological level displaying a grade of less than 3 on a 5-pt scale. ASIA impairment scale D- motor function is preserved below the neurological level with at least half of the key muscles below the neurological level displaying a grade of 3 or more on the 5-pt scale. for neurological level see: http://asia-spinalinjury.org/elearning/ASIA\_ISCOS\_high.pdf | Number | participants |
|
| Impairment Function | Tetraplegia- refers to impairment or loss of function in the cervical region with an effect to the upper and lower extremity Paraplegia- impairment or loss of function to the thoracic, lumbar, or sacral regions with an effect to the lower extremity | Number | participants |
|
| 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. |
| OG001 | 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. 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. |
|
|
| 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. | Posted | Mean | Standard Deviation | kg | Measured at Baseline (Time point 0), 3, and 6 months |
|
|
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| 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. | Posted | Mean | Standard Deviation | percent of total mass | Measured at Baseline (Time point 0), 3, and 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | ml/kg/min | 0, 1.5 and 3, 4.5, and 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | kg | Measured at Baseline (Time point 0) and 3 months |
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|
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| 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. | Posted | Mean | Standard Deviation | kg | Measured at Baseline (Time point 0), 3, and 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | meters | Measured Baseline (Time point 0) and 3 months |
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| 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. | Posted | Mean | Standard Deviation | seconds | Measured at Baseline (Time point 0) and 3 months |
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| 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. | Posted | Mean | Standard Deviation | steps | Measured at Baseline (Time point 0) and 3 months |
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| 1 |
| 15 |
| 5 |
| 15 |
| EG001 | 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.This group will switch to the 3-month robotic intervention after completing the home-based training program. | 0 | 6 | 3 | 6 |
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| Urinary Tract Infection (UTI) | Renal and urinary disorders | Systematic Assessment | One participant experienced several urinary tract infections during the course of the study. |
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| Bruise | Musculoskeletal and connective tissue disorders | Systematic Assessment | The participant experienced a bruise to the sternum and groin regions on 2 separate visits |
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| General pain and lethargy | General disorders | Systematic Assessment | Several participants experienced general skeletal muscle, back and knee pain |
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| Blood in urine | Renal and urinary disorders | Systematic Assessment | The participant observed blood in his urine. The participant was referred to his urologist for evaluation. This incident did not affect the participant's involvement in the training intervention. |
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| Hypotensive response | General disorders | Systematic Assessment | The participant began to experience dizziness and light-headed symptoms prior to a training intervention. A low blood pressure response may have been factor for this event |
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| Significant Weight Loss | General disorders | Systematic Assessment | The participant reported a 20 pound with loss during a 3-4 month time frame. The participant was instructed to schedule an appointment with his primary care physician for a complete evaluation. |
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| Ankle Swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment | The participant reported ankle swelling following a 45-minute robotic training session. The research medical staff evaluated the problem and cleared the participant to continue training with minimal limitations to the exercise intensity and duration. |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001519 | Behavior |
| Home stretch group pre (3 months) Body mass |
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| Home stretch group post Body mass (6 months) |
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| Home stretch group pre %Body fat (3 months) |
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| Home stretch group post %Body fat (6 months) |
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| Post (3 months) VO2 peak arm ergometry |
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| Home stretch group (3 months) pre Lokomat training |
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| Home stretch group midpoint (4.5 m) Lokomat |
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| Home stretch group post Lokomat (6 mod) |
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| Home stretch Group Pre Lean Muscle Mass (3 months) |
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| Home muscle Group Post Lean Muscle Mass (6 months) |
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| Home stretch Pre Bone Mineral Content (3 months) |
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| Home stretch Post Bone Mineral Content (6 months) |
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