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

Study Overview
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Brief Summary
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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.

Official Title
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Effects of a Home Based Walking Program Using Rhythmic Auditory Stimulation on Walking and Cortical Activation in Patients With Multiple Sclerosis.

Conditions
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Multiple Sclerosis, Ambulation Difficulty

Intervention / Treatment
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* Other: Rhythmic Auditory Stimulation (RAS)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Walking-Rhythmic Auditory Stimulation<br>Walking daily with Rhythmic Auditory Stimulation (RAS) based music for 4 weeks | Other: Rhythmic Auditory Stimulation (RAS)<br>* 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.<br>* Other names: RAS;|
| Active Comparator: Walking- only<br>Walking daily with no Rhythmic Auditory Stimulation (RAS) based music for 4 weeks | Other: Rhythmic Auditory Stimulation (RAS)<br>* 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.<br>* Other names: RAS;|
| Active Comparator: Rhythmic Auditory Stimulation (RAS)only<br>Listening to based music only daily for 4 weeks | Other: Rhythmic Auditory Stimulation (RAS)<br>* 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.<br>* Other names: RAS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks | 
| 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. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MS, Ambulation