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

Primary Purpose

Gait Disturbance in Multiple Sclerosis Patients

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rhythmic auditory stimulation
Walking exercise
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gait Disturbance in Multiple Sclerosis Patients focused on measuring Multiple Sclerosis, gait

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

RAS walking

RAS no walking

Walking no RAS

Arm Description

Subjects will walk while listening to music 20 minutes per day every day during the study period.

Subjects will be listening to music but not performing walking exercise, for 20 minutes per day every day during the study period.

Subjects will be walking without listening to music for 20 minutes per day every day during the study period

Outcomes

Primary Outcome Measures

Stride Length

Secondary Outcome Measures

25 foot walk time

Full Information

First Posted
January 29, 2010
Last Updated
June 24, 2022
Sponsor
The Cleveland Clinic
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01086371
Brief Title
Rhythmic Auditory Stimulation and Walking Performance in Multiple Sclerosis (MS) Patients
Official Title
Rhythmic Auditory Stimulation and Walking Performance in MS Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study being redesigned in anticipation of new study protocol.
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait Disturbance in Multiple Sclerosis Patients
Keywords
Multiple Sclerosis, gait

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois A Bethoux, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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

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