ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Restoration of Walking in Multiple Sclerosis Using Treadmill Training.

This study has been completed.
Study NCT00156676.   Last updated on June 3, 2008.   Information provided by Department of Veterans Affairs

This Tabular View shows the required WHO registration data elements as marked by

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

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 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
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:

  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:

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 
Principal Investigator:     Albert Lo, MD     Program to Integrate Psychosocial and Health Services in Chronic Diseases and Disability    
Information Provided By Department of Veterans Affairs
Verification Date June 2008
First Received Date  September 8, 2005
Last Updated Date June 3, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers