Ambulation Difficulty, Multiple Sclerosis
Conditions
Keywords
MS, Ambulation
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.
Interventions
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.
Sponsors
The Kelvin and Eleanor Smith Foundation
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| To assess changes in cortical activation induced by Rhythmic Auditory Stimulation in Multiple Sclerosis patients performing mental imagery of walking. | 8 weeks | Collect functional MRI images while performing guided imagery. |
Countries
United States
Outcome results
None listed