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Restoration of Walking in Multiple Sclerosis Using Treadmill Training.
This study has been completed.
Study NCT00156676   Information provided by Department of Veterans Affairs
First Received: September 8, 2005   Last Updated: June 3, 2008   History of Changes

September 8, 2005
June 3, 2008
September 2004
September 2007   (final data collection date for 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 ]
Timed 25 foot walk
Complete list of historical versions of study NCT00156676 on ClinicalTrials.gov Archive Site
 
Distance in 6 minutes. Isometric strength. Quality of life
 
Restoration of Walking in Multiple Sclerosis Using Treadmill Training.
Pilot Study on Gait & Motor Function in MS Using BWS Treadmill Training

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

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

 
Interventional
Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Multiple Sclerosis
  • Device: Body-weight supported treadmill
  • Device: Lokomat
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
30
September 2007
September 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

Clinical diagnosis of MS by McDonald criteria. EDSS level between 4-6.5.

Exclusion Criteria:

  1. Cardiovascular: recent MI < 4 wk, uncontrolled HTN >190/110 mmHg, Uncontrolled diabetes (blood glucose 2X above the upper limit of normal or non-fasting blood drain).
  2. Symptomatic fall in blood pressure (>30mm Hg), when upright in the body support apparatus, despite medical therapy.c)Circulatory problems, history of vascular claudication or pitting edema.

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:

Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00156676
Lo, Albert - Principal Investigator, Department of Veterans Affairs
B4031I
Department of Veterans Affairs
 
Principal Investigator: Albert Lo, MD Program to Integrate Psychosocial and Health Services in Chronic Diseases and Disability
Department of Veterans Affairs
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP