Status:
COMPLETED
Rhythmic Auditory Stimulation & Gait Training
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Consortium of Multiple Sclerosis Centers
MedRhythms, Inc.
Conditions:
Multiple Sclerosis
Gait Disorders, Neurologic
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study will enroll patients with Multiple Sclerosis and some difficulty with walking. The purpose of this study is to use Rhythmic Auditory Stimulation (RAS) a music therapy technique that provide...
Detailed Description
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 RAS can be deliver...
Eligibility Criteria
Inclusion
- Diagnosis of MS based on 2017 revised McDonald criteria (relapsing or progressive course)
- Performs the T25FW in 8 to 30 seconds (cane(s), walking stick(s), crutch(es), or wheeled walker allowed)
Exclusion
- Physical therapy in the past 3 months or immediate need for PT due to safety concerns (e.g. falls)
- Requires at least one seated rest during the 6 MW test
- Treatment with high-dose corticosteroids in the past 2 months or planned during the study period
- Lower extremity botulinum toxin (BT) injections for spasticity in the past 3 months, or planned during the study period
- Initiation of an oral symptomatic therapy which could affect walking in the past 4 weeks (particularly dalfampridine and medications for spasticity)
- Initiation of a new disease-modifying therapy for MS in the past 3 months
- Comorbidity compromising safe participation or affecting walking (e.g. uncontrolled cardiac or respiratory illness, musculoskeletal disorder)
- Severe hearing impairment with or without the use of hearing aids, such that the participant cannot hear the rhythmic music stimulus consistently.
- Inability to walk safely to the rhythmic music stimulus during the baseline visit.
Key Trial Info
Start Date :
June 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04314076
Start Date
June 8 2020
End Date
November 7 2022
Last Update
February 9 2023
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195