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Restoration of Walking in Multiple Sclerosis Using Treadmill Training.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00156676
First received: September 8, 2005
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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 Intervention
Multiple Sclerosis
Device: Body-weight supported treadmill
Device: Lokomat

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study on Gait & Motor Function in MS Using BWS Treadmill Training

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 30
Study Start Date: September 2004
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156676

Locations
United States, Rhode Island
Providence VA Medical Center
Providence, Rhode Island, United States, 02908-4799
Sponsors and Collaborators
Investigators
Principal Investigator: Albert Lo, MD PhD Providence VA Medical Center
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00156676     History of Changes
Obsolete Identifiers: NCT00127426
Other Study ID Numbers: B4031-I
Study First Received: September 8, 2005
Last Updated: September 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Disability
Gait
Multiple Sclerosis
Rehabilitation
Robot

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

ClinicalTrials.gov processed this record on November 20, 2014