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Clinical Trials/NCT02065284
NCT02065284
Completed
N/A

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

The Cleveland Clinic1 site in 1 country32 target enrollmentFebruary 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
The Cleveland Clinic
Enrollment
32
Locations
1
Primary Endpoint
Improved gait pattern on gait analysis
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
November 2015
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Improved gait pattern on gait analysis

Time Frame: 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 Outcomes

  • Improved walk time on the timed 25 foot walk test(8 weeks)
  • Improved distance on the 2 minute walk test(8 weeks)

Study Sites (1)

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