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Restoration of Walking in Multiple Sclerosis Using Treadmill Training.

NCT ID: NCT00156676

Last Updated: 2013-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2007-09-30

Brief Summary

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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

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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

Conditions

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Multiple Sclerosis

Keywords

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Disability Gait Multiple Sclerosis Rehabilitation Robot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Cross over from body-weight support treadmill to Lokomat

Group Type EXPERIMENTAL

Body-weight supported treadmill

Intervention Type DEVICE

Lokomat

Intervention Type DEVICE

Arm 2

Cross over from Lokomat to body-weight support treadmill

Group Type EXPERIMENTAL

Body-weight supported treadmill

Intervention Type DEVICE

Lokomat

Intervention Type DEVICE

Interventions

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Body-weight supported treadmill

Intervention Type DEVICE

Lokomat

Intervention Type DEVICE

Body-weight supported treadmill

Intervention Type DEVICE

Lokomat

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Albert Lo, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Providence VA Medical Center

Locations

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Providence VA Medical Center

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 18971381 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21674396 (View on PubMed)

Other Identifiers

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B4031-I

Identifier Type: -

Identifier Source: org_study_id

NCT00127426

Identifier Type: -

Identifier Source: nct_alias