Restoration of Walking in Multiple Sclerosis Using Treadmill Training.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00156676
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : September 20, 2013
Information provided by (Responsible Party):
VA Office of Research and Development

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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: Body-weight supported treadmill Device: Lokomat Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study on Gait & Motor Function in MS Using BWS Treadmill Training
Study Start Date : September 2004
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1
Cross over from body-weight support treadmill to Lokomat
Device: Body-weight supported treadmill Device: Lokomat
Experimental: Arm 2
Cross over from Lokomat to body-weight support treadmill
Device: Body-weight supported treadmill Device: Lokomat

Primary Outcome Measures :
  1. Mean changes and variances in ambulation, motor, fatigue and quality of life [ Time Frame: Baseline, cross-over, study endpoint ]
    Timed 25 foot walk

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).
  • Symptomatic fall in blood pressure (>30mm Hg), when upright in the body support apparatus, despite medical therapy.
  • Circulatory problems, history of vascular claudication or pitting edema.
  • Cognitive impairment MMSE < 21.
  • Body weight over 150 kg (structural limits of the Lokomat).
  • Lower extremity injuries that limit range of motion or function.
  • Joint problems (hip or leg) that limit range of motion or cause pain with movement despite treatment.
  • Unstable fractures.
  • Pressure sores with any skin breakdown in areas in contact with the body harness or DGO apparatus.
  • Chronic and ongoing alcohol or drug abuse.
  • Pre-morbid, ongoing depression or psychosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00156676

United States, Rhode Island
Providence VA Medical Center
Providence, Rhode Island, United States, 02908-4799
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Albert Lo, MD PhD Providence VA Medical Center

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: VA Office of Research and Development Identifier: NCT00156676     History of Changes
Obsolete Identifiers: NCT00127426
Other Study ID Numbers: B4031-I
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: September 2013

Keywords provided by VA Office of Research and Development:
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases