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| Descriptive Information Fields | |||||
| Brief Title † | Restoration of Walking in Multiple Sclerosis Using Treadmill Training. | ||||
| Official Title † | Pilot Study on Gait & Motor Function in MS Using BWS Treadmill Training | ||||
| Brief Summary | The primary purpose of this study is to collect preliminary and pilot data to begin to determine whether the use of body weight support treadmill therapy (BWSTT) with and without driven-gait-orthotics (DGO), results in improved motor recovery and ambulation MS patients with gait impairment |
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| Detailed Description | Gait impairment is a major cause of ongoing disability in patients with multiple sclerosis (MS). New treadmills that provide body weight support and even robotic assistance to the lower limbs have recently been developed and are now commercially available. These treadmills allow the subject to execute the integrated process of walking in a task-specific manner that is repetitively reinforced in a normal pattern. Data from studies using these body-weight supported treadmills (BWSTT) in spinal cord injury and stroke patients suggest that intensive task-specific gait rehabilitative training may help to restore a normative gait pattern, improve overground walking and enhance quality of life in multiple sclerosis patients with neurological gait impairment. In this study, we propose a series of prospective longitudinal clinical studies to collect pilot data on the use of task-specific BWSTT +/- Lokomat on improving ambulation, motor function and quality of life for MS patients with mild to moderate gait difficulty. Pilot data will also be collected for the effect conventional rehabilitation has on ambulation and motor outcomes as well as how these outcomes change during usual care. Our clinical research goals are to capture the initial pilot data (mean changes and variances in ambulation, motor, fatigue and quality of life outcomes) to facilitate the design of a larger clinical trial to test efficacy if these preliminary data are promising. The planned studies will study the effect of two forms of task specific training (BWSTT alone and BWSTT combined with Lokomat) compared to conventional gait rehabilitative methods and usual care |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | Mean changes and variances in ambulation, motor, fatigue and quality of life [ Time Frame: Baseline, cross-over, study endpoint ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Multiple Sclerosis | ||||
| Intervention † | Device: Body-weight supported treadmill Device: Lokomat |
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| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 30 | ||||
| Start Date † | September 2004 | ||||
| Completion Date | September 2007 | ||||
| Eligibility Criteria † | Inclusion Criteria: Clinical diagnosis of MS by McDonald criteria. EDSS level between 4-6.5. Exclusion Criteria:
d)Cognitive impairment MMSE < 21.e)Body weight over 150 kg (structural limits of the Lokomat). f)Lower extremity injuries that limit range of motion or function. g)Joint problems (hip or leg) that limit range of motion or cause pain with movement despite treatment. h)Unstable fractures. i)Pressure sores with any skin breakdown in areas in contact with the body harness or DGO apparatus. j)Chronic and ongoing alcohol or drug abuse. k)Pre-morbid, ongoing depression or psychosis. Exclusion Criteria: |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00156676 | ||||
| Organization ID | B4031I | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Department of Veterans Affairs | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | June 2008 | ||||
| First Received Date † | September 8, 2005 | ||||
| Last Updated Date | June 3, 2008 | ||||