Restoration of Walking in Multiple Sclerosis Using Treadmill Training.

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Device: Body-weight supported treadmill; Device: Lokomat

• Registration Number: NCT00156676
• Lead Sponsor: US Department of Veterans Affairs

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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-18
• Last Update Posted: 2013-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Body-weight supported treadmill	Cross over from body-weight support treadmill to Lokomat
Arm 1	Lokomat	Cross over from body-weight support treadmill to Lokomat
Arm 2	Body-weight supported treadmill	Cross over from Lokomat to body-weight support treadmill
Arm 2	Lokomat	Cross over from Lokomat to body-weight support treadmill

Primary Outcome Measures

Name	Time	Method
Mean changes and variances in ambulation, motor, fatigue and quality of life	Baseline, cross-over, study endpoint	Timed 25 foot walk

Trial Locations

Locations (1)

Providence VA Medical Center; 🇺🇸 Providence, Rhode Island, United States