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: Lokomat  Device: Body-weight supported treadmill

Further Study Details: 

Primary Outcomes: Timed 25 foot walk
Secondary Outcomes: Distance in 6 minutes. Isometric strength. Quality of life
Expected Total Enrollment:  30

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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00156676

Albert LO, MD, PhD, CPH      203-937-4724    albert.lo@va.gov

Connecticut
      VACT Healthcare System West Haven, West Haven,  Connecticut,  06516,  United States; Recruiting

Study chairs or principal investigators

Albert LO, MD, PhD, CPH,  Principal Investigator,  Staff Physician, Department of Neurology / Research Service, VACT HCS West Haven   

Study ID Numbers:  B4031I
Last Updated:  September 9, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00156676
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13