Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156676
Status:
COMPLETED
Last Update Posted:
2013-09-20
First Post:
2005-09-08
Brief Title:
Restoration of Walking in Multiple Sclerosis Using Treadmill Training
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Pilot Study on Gait Motor Function in MS Using BWS Treadmill Training
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None