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

June 24, 2022 updated by: Francois Bethoux, MD, The Cleveland Clinic

Rhythmic Auditory Stimulation and Walking Performance in MS Patients

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Thirty three patients will be recruited for the study.There will be three study groups 1)the walking and music group,2)music only no walking group 3)walking only no music group The subjects in the walking + music group and the music - no walking group will be provided a list of songs to choose from. MP3 players will be provided that contain the chosen music, which has been altered electronically with an embedded beat and set to their baseline walking cadence +10%. The subjects in the walking + music group will be instructed to walk while listening to the music for 20 minutes per day every day. The subjects in the music - no walking group will be instructed to sit in a chair and listen to the music for 20 minutes per day every day. The subjects in the walking -no music group will be instructed to walk for 20 minutes per day every day. The total duration of the interventions will be 3 weeks.

Study schedule Visit 1 (baseline): informed consent will be obtained. Subjects will be screened for inclusion/exclusion criteria.Subjects qualified for the study will be randomized to the treatment (MT) or control (C) group. Baseline assessments will be performed on all subjects.Subjects in the walking+music group and the music- no walking group will be given mp3 players with music.

Visit 2 (week 3): assessments will be performed on all subjects.All subjects will be instructed to discontinue walking and music regimens.

Visit 3 (week 5): All subjects will return for final assessments.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 years or older
  • Diagnosis of multiple sclerosis documented in medical records
  • Able to walk at least 100 feet without physical assistance (use of assistive devices such as cane, crutch, or walker is allowed.

Exclusion Criteria:

  • Treatment for an MS exacerbation in the past 30 days
  • Severe co morbidity precluding participation in the study per investigator's judgment (e.g. severe cardiac or respiratory failure)
  • Severe cognitive deficits precluding informed consent or preventing the subject from following study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RAS walking
Subjects will walk while listening to music 20 minutes per day every day during the study period.
Other: Rhythmic auditory stimulation
Recorded music with embedded beat set 10% above the subject's baseline walking cadence.
Other Names:
  • Rythmic Auditory Stimulation, RAS, Music
Other: Walking exercise
Subjects will be walking daily for a total of 20 minutes (may be broken down to smaller time periods.
Other Names:
  • Walking
Active Comparator: RAS no walking
Subjects will be listening to music but not performing walking exercise, for 20 minutes per day every day during the study period.
Other: Rhythmic auditory stimulation
Recorded music with embedded beat set 10% above the subject's baseline walking cadence.
Other Names:
  • Rythmic Auditory Stimulation, RAS, Music
Active Comparator: Walking no RAS
Subjects will be walking without listening to music for 20 minutes per day every day during the study period
Other: Walking exercise
Subjects will be walking daily for a total of 20 minutes (may be broken down to smaller time periods.
Other Names:
  • Walking

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stride Length
Time Frame: each study visit: baseline, week 3, and week 5 a total of 3 visits over a 5 week period of time
each study visit: baseline, week 3, and week 5 a total of 3 visits over a 5 week period of time

Secondary Outcome Measures

Outcome Measure
Time Frame
25 foot walk time
Time Frame: each study visit: baseline, week 3, and week 5 a total of 3 visits over a 5 week period
each study visit: baseline, week 3, and week 5 a total of 3 visits over a 5 week period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Francois A Bethoux, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

January 29, 2010

First Submitted That Met QC Criteria

March 11, 2010

First Posted (Estimate)

March 15, 2010

Study Record Updates

Last Update Posted (Actual)

June 27, 2022

Last Update Submitted That Met QC Criteria

June 24, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAS Gait MS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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