Restoration of Walking in Multiple Sclerosis Using Treadmill Training.

Multiple Sclerosis Clinical Trial

Official title:

Pilot Study on Gait & Motor Function in MS Using BWS Treadmill Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00156676
• Other study ID #: B4031-I
• Status: Completed
• Phase: N/A
• First received: September 8, 2005
• Last updated: September 18, 2013
• Start date: September 2004
• Est. completion date: September 2007

Study information

• Verified date: September 2013
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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

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

Other known NCT identifiers

• NCT00127426

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• Body-weight supported treadmill

• Lokomat

• Body-weight supported treadmill

• Lokomat

Locations

Country	Name	City	State
United States	Providence VA Medical Center	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lo AC, Triche EW. Improving gait in multiple sclerosis using robot-assisted, body weight supported treadmill training. Neurorehabil Neural Repair. 2008 Nov-Dec;22(6):661-71. doi: 10.1177/1545968308318473. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean changes and variances in ambulation, motor, fatigue and quality of life	Timed 25 foot walk	Baseline, cross-over, study endpoint	No