Baltimore, MD 21207
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Research and Technology
Clinical Trials
Cardiovascular Fitness for Robotically Assisted Treadmill Training in Persons With Chronic Incomplete Spinal Cord Injury
Overview
This proposal investigates the hypothesis that progressive aerobic exercise with Lokomat is feasible in people with motor incomplete spinal cord injury, theorizing that three months of training will improve cardiovascular fitness and gait functionality when compared to other physical therapy controls.
| Condition | Intervention |
|---|---|
Paraplegia |
Device: Lokomat Training |
MedlinePlus related topics:
| Study Type: | Interventional |
|---|---|
| Study Design: | Active Control, Crossover Assignment, Efficacy Study, Open Label, Randomized, Treatment |
| Official Title: | Cardiovascular Parameters for Lokomat Training in Chronic Incomplete SCI |
Further study details as provided by Department of Veterans Affairs:
Primary Outcome Measures:
- Cardiovascular fitness as determined by VO2 peak measurements [Time Frame: Measurements taken at 1-1/2 and 3 months] [Designated as safety issue: No]
Secondary Outcome Measures:
- Functional improvement as determined by timed walks and gait parameters [Time Frame: Measured at 1-1/2 and 3 months] [Designated as safety issue: No]
| Estimated Enrollment: | 36 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: 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. |
Device: Lokomat Training The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis. |
| 2: Active Comparator Patients will participate in a home stretching program for 3 months. |
Other: 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 monitered via telephone by the study coordinator. This will be an active control arm. |
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, theorizing that three months of training will improve cardiovascular fitness and gait functionality when compared to other 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 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, 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 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.
Eligibility
Ages eligible for study: 18 to 80 years of age.
Genders eligible for study: Both
Accepts healthy volunteers: No
Criteria
Inclusion Criteria:
- Acute onset Spinal Cord Injury or Disease at least 12 months prior to enrollment
- Age 21 to 65
- 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, CHF or valvular dysfunction
- History of recent hospitalization (< 3 months) for a major medical problem
- Functional improvement as determined by timed walks and gait parameters
For More Information
The principal investigator at Kernan Hospital for the Lokomat trial is Peter Gorman, MD. He may be contacted directly at 410-448-6265 or via e-mail at pgorman@kernan.umm.edu.