Spinal Cord Injury Clinical Trial
Official title:
Cardiovascular Parameters for Lokomat Training in Chronic Incomplete SCI
Verified date | April 2014 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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
Status | Completed |
Enrollment | 18 |
Est. completion date | June 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland Rehabilitation and Orthopaedic Institute | Baltimore | Maryland |
United States | VA Maryland Health Care System, Baltimore | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | Kernan Orthopaedics and Rehabilitation Hospital, University of Maryland |
United States,
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 A — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. |
0, 1.5 and 3, 4.5, and 6 months | No |
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. |
0, 1.5 and 3, 4.5, and 6 months | No |
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. |
Measured at Baseline (Time point 0), 3, and 6 months | No |
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. |
Measured at Baseline (Time point 0), 3, and 6 months | No |
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. |
Measured at Baseline (Time point 0) and 3 months | No |
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. |
Measured at Baseline (Time point 0), 3, and 6 months | No |
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. |
Measured Baseline (Time point 0) and 3 months | No |
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. |
Measured at Baseline (Time point 0) and 3 months | No |
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. |
Measured at Baseline (Time point 0) and 3 months | No |
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