MedTrace Logo

Rhythmic Auditory Stimulation and Walking Performance in Multiple Sclerosis (MS) Patients

NCT01086371 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-06-27

No results posted yet for this study

Summary

The study is being conducted to determine if a home-based walking program that uses RAS (Rhythmic Auditory Stimulation)is a viable and effective treatment of gait instability for people with MS.We hypothesize that an RAS-based home walking program will demonstrate significant improvements over both regular exercise and no exercise. To test this hypothesis we will compare between group differences from baseline and three weeks of intervention on 3 quantitative gait measures and 1 standardized MS measurement from the following 3 groups: RAS walking, RAS no walking Other: Walking exercise The secondary goal of the study will be to determine any carry-over effects of RAS on gait parameters in ambulatory patients with MS. We hypothesize that RAS will produce sustained changes in gait pattern due to entrainment processes. To test this hypothesis, we will compare gait parameters two weeks following the cessation of the intervention with baseline and with the last week of intervention.

The third goal of this study is to determine if RAS-enhanced exercise has any transfer to improve other areas such as upper extremity function and/or cognitive function. We hypothesize that those participating in an RAS-based home walking program will demonstrate improvements in other domain areas, such as cognitive and upper body functioning. To test this hypothesis we will compare results from the Multiple Sclerosis Functional Composite(MSFC) taken at baseline and again at the end of the treatment phase for all three groups.

Conditions

  • Gait Disturbance in Multiple Sclerosis Patients

Interventions

OTHER

Rhythmic auditory stimulation

Recorded music with embedded beat set 10% above the subject's baseline walking cadence.

OTHER

Walking exercise

Subjects will be walking daily for a total of 20 minutes (may be broken down to smaller time periods.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Francois A Bethoux, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01086371 on ClinicalTrials.gov