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

This study has been completed.
Sponsor:
Collaborator:
The Kelvin and Eleanor Smith Foundation
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT02065284
First received: February 13, 2014
Last updated: November 6, 2015
Last verified: November 2015
  Purpose

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.


Condition Intervention
Multiple Sclerosis
Ambulation Difficulty
Other: Rhythmic Auditory Stimulation (RAS)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Home Based Walking Program Using Rhythmic Auditory Stimulation on Walking and Cortical Activation in Patients With Multiple Sclerosis.

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Improved gait pattern on gait analysis [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • To assess changes in cortical activation induced by Rhythmic Auditory Stimulation in Multiple Sclerosis patients performing mental imagery of walking. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Collect functional MRI images while performing guided imagery.


Enrollment: 32
Study Start Date: February 2014
Study Completion Date: November 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Walking-Rhythmic Auditory Stimulation
Walking daily with Rhythmic Auditory Stimulation (RAS) based music for 4 weeks
Other: Rhythmic Auditory Stimulation (RAS)
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.
Other Name: RAS
Active Comparator: Walking- only
Walking daily with no Rhythmic Auditory Stimulation (RAS) based music for 4 weeks
Other: Rhythmic Auditory Stimulation (RAS)
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.
Other Name: RAS
Active Comparator: Rhythmic Auditory Stimulation (RAS)only
Listening to based music only daily for 4 weeks
Other: Rhythmic Auditory Stimulation (RAS)
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.
Other Name: RAS

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02065284

Locations
United States, Ohio
Cleveland Clinic Neurological Institute Mellen Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
The Kelvin and Eleanor Smith Foundation
Investigators
Principal Investigator: Francois A Bethoux, MD The Cleveland Clinic
  More Information

Publications:
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02065284     History of Changes
Other Study ID Numbers: HBWP and RAS 
Study First Received: February 13, 2014
Last Updated: November 6, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
MS
Ambulation

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Mobility Limitation
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 30, 2016