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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065284
• Other study ID #: HBWP and RAS
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: November 2015

Study information

• Verified date: June 2022
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ambulation Difficulty
• Mobility Limitation
• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Neurological Institute Mellen Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	The Kelvin and Eleanor Smith Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To assess changes in cortical activation induced by Rhythmic Auditory Stimulation in Multiple Sclerosis patients performing mental imagery of walking.	Collect functional MRI images while performing guided imagery.	8 weeks
Primary	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	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
Secondary	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