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

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ClinicalTrials.gov Identifier: NCT01086371
Recruitment Status : Withdrawn (Study being redesigned in anticipation of new study protocol.)
First Posted : March 15, 2010
Last Update Posted : January 19, 2012
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
The Cleveland Clinic

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.


Condition or disease Intervention/treatment Phase
Gait Disturbance in Multiple Sclerosis Patients Other: Rhythmic auditory stimulation Other: Walking exercise Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rhythmic Auditory Stimulation and Walking Performance in MS Patients
Study Start Date : January 2012
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: Walking




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086371


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Francois A Bethoux, MD The Cleveland Clinic
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Responsible Party: Francois Bethoux MD, Clevland Clinic
ClinicalTrials.gov Identifier: NCT01086371    
Other Study ID Numbers: RAS Gait MS
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: January 2012
Keywords provided by The Cleveland Clinic:
Multiple Sclerosis
gait
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases