search
Back to results

Restoration of Walking in Multiple Sclerosis Using Treadmill Training.

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Body-weight supported treadmill
Lokomat
Body-weight supported treadmill
Lokomat
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Disability, Gait, Multiple Sclerosis, Rehabilitation, Robot

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Providence VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

Cross over from body-weight support treadmill to Lokomat

Cross over from Lokomat to body-weight support treadmill

Outcomes

Primary Outcome Measures

Mean changes and variances in ambulation, motor, fatigue and quality of life
Timed 25 foot walk

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
September 18, 2013
Sponsor
US Department of Veterans Affairs
search

1. Study Identification

Unique Protocol Identification Number
NCT00156676
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Disability, Gait, Multiple Sclerosis, Rehabilitation, Robot

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Cross over from body-weight support treadmill to Lokomat
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Cross over from Lokomat to body-weight support treadmill
Intervention Type
Device
Intervention Name(s)
Body-weight supported treadmill
Intervention Type
Device
Intervention Name(s)
Lokomat
Intervention Type
Device
Intervention Name(s)
Body-weight supported treadmill
Intervention Type
Device
Intervention Name(s)
Lokomat
Primary Outcome Measure Information:
Title
Mean changes and variances in ambulation, motor, fatigue and quality of life
Description
Timed 25 foot walk
Time Frame
Baseline, cross-over, study endpoint

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Lo, MD PhD
Organizational Affiliation
Providence VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence VA Medical Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908-4799
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18971381
Citation
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.
Results Reference
result
PubMed Identifier
21674396
Citation
Wier LM, Hatcher MS, Triche EW, Lo AC. Effect of robot-assisted versus conventional body-weight-supported treadmill training on quality of life for people with multiple sclerosis. J Rehabil Res Dev. 2011;48(4):483-92. doi: 10.1682/jrrd.2010.03.0035.
Results Reference
derived

Learn more about this trial

Restoration of Walking in Multiple Sclerosis Using Treadmill Training.

We'll reach out to this number within 24 hrs