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

Not Applicable

Completed

• Conditions: Multiple Sclerosis; Ambulation Difficulty
• Interventions: Other: Rhythmic Auditory Stimulation (RAS)

• Registration Number: NCT02065284
• Lead Sponsor: The Cleveland Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-13
• Study First Submitted QC: 2014-02-13
• Study First Posted: 2014-02-19
• Primary Completion: 2015-09
• Study Completion: 2015-11
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-15
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Walking-Rhythmic Auditory Stimulation	Rhythmic Auditory Stimulation (RAS)	Walking daily with Rhythmic Auditory Stimulation (RAS) based music for 4 weeks
Walking- only	Rhythmic Auditory Stimulation (RAS)	Walking daily with no Rhythmic Auditory Stimulation (RAS) based music for 4 weeks
Rhythmic Auditory Stimulation (RAS)only	Rhythmic Auditory Stimulation (RAS)	Listening to based music only daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
Improved gait pattern on gait analysis	8 weeks	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

Name	Time	Method
Improved walk time on the timed 25 foot walk test	8 weeks	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	8 weeks	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.

Trial Locations

Locations (1)

Cleveland Clinic Neurological Institute Mellen Center; 🇺🇸 Cleveland, Ohio, United States