Trials / Completed
CompletedNCT00156676
Restoration of Walking in Multiple Sclerosis Using Treadmill Training.
Pilot Study on Gait & Motor Function in MS Using BWS Treadmill Training
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- US Department of Veterans Affairs · Federal
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Body-weight supported treadmill | |
| DEVICE | Lokomat | |
| DEVICE | Body-weight supported treadmill | |
| DEVICE | Lokomat |
Timeline
- Start date
- 2004-09-01
- Primary completion
- 2007-09-01
- Completion
- 2007-09-01
- First posted
- 2005-09-12
- Last updated
- 2013-09-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00156676. Inclusion in this directory is not an endorsement.