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Effects of a Home Based Walking Program Using Rhythmic Auditory Stimulation in Patients With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis, Ambulation Difficulty

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rhythmic Auditory Stimulation (RAS)
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring MS, Ambulation

Eligibility Criteria

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

Inclusion Criteria:

  1. age 18 years or older
  2. diagnosis of MS per Mc Donald criteria
  3. Ambulation Index score from 2 to 6 inclusive (clinically observable gait disturbance, whether the subject walks with no, unilateral, or bilateral support)
  4. spastic paresis is the main neurologic impairment causing the gait disturbance, per investigator's judgment.

Exclusion Criteria:

  1. neurologic impairments other than spastic paresis (e.g. cerebellar ataxia or sensory ataxia), or non-neurologic impairments (e.g. musculoskeletal problems) play a major role in the subject's gait disturbance, per investigator's judgment;
  2. treatment for an MS exacerbation in the past 30 days;
  3. severe co morbidity precluding participation in the study per investigator's judgment (e.g. severe cardiac or respiratory failure);
  4. severe cognitive deficits precluding informed consent or preventing the subject from following study procedures safely
  5. contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips etc.
  6. pregnancy.

Sites / Locations

  • Cleveland Clinic Neurological Institute Mellen Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Walking-Rhythmic Auditory Stimulation

Walking- only

Rhythmic Auditory Stimulation (RAS)only

Arm Description

Walking daily with Rhythmic Auditory Stimulation (RAS) based music for 4 weeks

Walking daily with no Rhythmic Auditory Stimulation (RAS) based music for 4 weeks

Listening to based music only daily for 4 weeks

Outcomes

Primary Outcome Measures

Improved gait pattern on gait analysis
To compare the effect on gait pattern of a walking program with Rhythmic Auditory Stimulation, to that of a walking program without Rhythmic Auditory Stimulation, or Rhythmic Auditory Stimulation without walking exercise.

Secondary Outcome Measures

Improved walk time on the timed 25 foot walk test
To compare the effect on walking performance of a walking program with Rhythmic Auditory Stimulation, to that of a walking program without Rhythmic Auditory Stimulation, or Rhythmic Auditory Stimulation without walking exercise.
Improved distance on the 2 minute walk test
To compare the effect on walking performance of a walking program with Rhythmic Auditory Stimulation, to that of a walking program without Rhythmic Auditory Stimulation, or Rhythmic Auditory Stimulation without walking exercise.

Full Information

First Posted
February 13, 2014
Last Updated
June 15, 2022
Sponsor
The Cleveland Clinic
Collaborators
The Kelvin and Eleanor Smith Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02065284
Brief Title
Effects of a Home Based Walking Program Using Rhythmic Auditory Stimulation in Patients With Multiple Sclerosis
Official Title
Effects of a Home Based Walking Program Using Rhythmic Auditory Stimulation on Walking and Cortical Activation in Patients With Multiple Sclerosis.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
Collaborators
The Kelvin and Eleanor Smith Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Rhythmic Auditory Stimulation (RAS) is a music therapy technique that provides rhythmic auditory cues (like a beat) to help improve patients' movements, especially when walking. The purpose of this study is to compare the effect on walking performance of a home based walking program (HBWP) with Rhythmic Auditory Stimulation (RAS), to that of a HBWP without RAS, or to RAS without walking exercise. A second part of this study will assess the effects of Rhythmic Auditory Stimulation (RAS) on brain activity in patients with Multiple Sclerosis while performing mental imagery of walking.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Ambulation Difficulty
Keywords
MS, Ambulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Walking-Rhythmic Auditory Stimulation
Arm Type
Active Comparator
Arm Description
Walking daily with Rhythmic Auditory Stimulation (RAS) based music for 4 weeks
Arm Title
Walking- only
Arm Type
Active Comparator
Arm Description
Walking daily with no Rhythmic Auditory Stimulation (RAS) based music for 4 weeks
Arm Title
Rhythmic Auditory Stimulation (RAS)only
Arm Type
Active Comparator
Arm Description
Listening to based music only daily for 4 weeks
Intervention Type
Other
Intervention Name(s)
Rhythmic Auditory Stimulation (RAS)
Other Intervention Name(s)
RAS
Intervention Description
Rhythmic Auditory Stimulation (RAS) is a music therapy technique that provides rhythmic auditory cues (like a beat) to help improve patients' movements, especially when walking.
Primary Outcome Measure Information:
Title
Improved gait pattern on gait analysis
Description
To compare the effect on gait pattern of a walking program with Rhythmic Auditory Stimulation, to that of a walking program without Rhythmic Auditory Stimulation, or Rhythmic Auditory Stimulation without walking exercise.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Improved walk time on the timed 25 foot walk test
Description
To compare the effect on walking performance of a walking program with Rhythmic Auditory Stimulation, to that of a walking program without Rhythmic Auditory Stimulation, or Rhythmic Auditory Stimulation without walking exercise.
Time Frame
8 weeks
Title
Improved distance on the 2 minute walk test
Description
To compare the effect on walking performance of a walking program with Rhythmic Auditory Stimulation, to that of a walking program without Rhythmic Auditory Stimulation, or Rhythmic Auditory Stimulation without walking exercise.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
To assess changes in cortical activation induced by Rhythmic Auditory Stimulation in Multiple Sclerosis patients performing mental imagery of walking.
Description
Collect functional MRI images while performing guided imagery.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18 years or older diagnosis of MS per Mc Donald criteria Ambulation Index score from 2 to 6 inclusive (clinically observable gait disturbance, whether the subject walks with no, unilateral, or bilateral support) spastic paresis is the main neurologic impairment causing the gait disturbance, per investigator's judgment. Exclusion Criteria: neurologic impairments other than spastic paresis (e.g. cerebellar ataxia or sensory ataxia), or non-neurologic impairments (e.g. musculoskeletal problems) play a major role in the subject's gait disturbance, per investigator's judgment; 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 safely contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips etc. pregnancy.
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 Neurological Institute Mellen Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20643882
Citation
Conklyn D, Stough D, Novak E, Paczak S, Chemali K, Bethoux F. A home-based walking program using rhythmic auditory stimulation improves gait performance in patients with multiple sclerosis: a pilot study. Neurorehabil Neural Repair. 2010 Nov-Dec;24(9):835-42. doi: 10.1177/1545968310372139. Epub 2010 Jul 19.
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Effects of a Home Based Walking Program Using Rhythmic Auditory Stimulation in Patients With Multiple Sclerosis

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