Clinical trial NCT02065284: Effects of a Home Based Walking Program Using Rhythmic Auditory Stimulation in Patients With Multiple Sclerosis
Official title: Effects of a Home Based Walking Program Using Rhythmic Auditory Stimulation on Walking and Cortical Activation in Patients With Multiple Sclerosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Ambulation Difficulty
Keywords: MS
Ambulation
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: The Kelvin and Eleanor Smith Foundation
First posted: 2014-02-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Improved gait pattern on gait analysis
timeFrame: 8 weeks
Secondary outcomes:
measure: Improved walk time on the timed 25 foot walk test
timeFrame: 8 weeks
measure: Improved distance on the 2 minute walk test
timeFrame: 8 weeks
Other outcomes:
measure: To assess changes in cortical activation induced by Rhythmic Auditory Stimulation in Multiple Sclerosis patients performing mental imagery of walking.
timeFrame: 8 weeks
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Neurological Institute Mellen Center
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Francois A Bethoux, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.