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Sponsors and Collaborators: |
Department of Veterans Affairs University of Maryland |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00385918 |
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
Condition | Intervention |
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Paraplegia Quadriplegia Spinal Cord Injury Tetraplegia |
Device: Lokomat Training Other: Home stretching protocol |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Cardiovascular Parameters for Lokomat Training in Chronic Incomplete SCI |
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 |
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1: Experimental
Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approx 45 minutes.
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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.
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2: Active Comparator
Patients will participate in a home stretching program for 3 months.
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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.
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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 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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gertrude Morrison, RN | (410) 448-6831 | gmorrison@kernan.umm.edu |
Contact: William Scott | (410) 448-6433 | wscott@kernan.umm.edu |
United States, Maryland | |
VA Maryland Health Care System, Baltimore | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Peter Gorman, MD MS 410-605-7167 peter.gorman@va.gov | |
Contact: David G Johnson, MD (520) 626-6721 | |
Principal Investigator: Peter Gorman, MD MS |
Principal Investigator: | Peter Gorman, MD MS | VA Maryland Health Care System, Baltimore |
Responsible Party: | Department of Veterans Affairs ( Gorman, Peter - Principal Investigator ) |
Study ID Numbers: | B4027, B40271 |
Study First Received: | October 6, 2006 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00385918 |
Health Authority: | United States: Federal Government |
Cardiovascular Fitness Exercise Gait Spinal Cord Injury Treadmill Training |
Paralysis Signs and Symptoms Spinal Cord Injuries Spinal Cord Diseases Wounds and Injuries Paraplegia |
Disorders of Environmental Origin Central Nervous System Diseases Neurologic Manifestations Trauma, Nervous System Quadriplegia |
Nervous System Diseases |