Rhythmic Auditory Stimulation & Gait Training

Study Overview
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Brief Summary
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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 provides rhythmic auditory cues (like a beat) to help improve a patient's movements, especially when walking. Participants will be asked to participate in a walking program (WP) with Rhythmic Auditory Stimulation (RAS), or a WP without RAS.

Detailed Description
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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 delivered at a fixed tempo or interactive tempo. The device used in this study will deliver an interactive tempo. The equipment will include a mobile device app and sensors that are attached to the participant's shoes. Headphones and smartphones will be required to use the device and will be provided to the study team and kept at the center for this study. The device is designed to use audio cues to facilitate improvements in the participant's walking speed while listening to music. The overall purpose of this study is to assess the safety and acceptability of interactive RAS music combined with gait training in individuals with MS and walking impairment, and to gather preliminary efficacy data for future studies.

Official Title
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A Pilot Single-blind Randomized Controlled Trial to Evaluate the Safety and Feasibility of Rhythmic Auditory Stimulation for Gait Training in Persons With Multiple Sclerosis

Conditions
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Multiple Sclerosis, Gait Disorders, Neurologic

Intervention / Treatment
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* Other: Rhythmic auditory stimulation
* Other: Gait Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a single blind parallel-group pilot randomized controlled trial comparing rhythmic auditory stimulation (RAS) with gait training to gait training without RAS.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gait Training (GT) with Rhythmic Auditory Stimulation (RAS)<br>Participants in this arm will complete 16 supervised gait training sessions consisting of continuous overground walking on a track for 30 minutes,with RAS | Other: Rhythmic auditory stimulation<br>* RAS, a Neurologic Music Therapy technique developed to utilize rhythm and timing cues to assist in improving the basic, intrinsic rhythmic movements of gait.<br>* Other names: RAS;|
| Other: Gait training (GT) without Rhythmic Auditory Stimulation (RAS)<br>Participants in this arm will complete 16 supervised gait training sessions consisting of continuous overground walking on a track for 30 minutes without RAS | Other: Gait Training<br>* Continuous overground walking on a track for 30 minutes. Gait training will primarily consist of walking exercise under the supervision of an exercise physiologist.<br>* Other names: GT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events | Adverse events will be collected throughout the study period to assess treatment safety. | through study completion, up to 16 weeks | 
| Percentage of training sessions missed. | Training session attendance will be tracked as an indicator of feasibility throughout the treatment period. | through end of treatment, up to 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed 25 Foot Walk | Participants are instructed to walk as fast as possible but safely on a 25-foot straight course. | Week 0, Week 9 and week 16 | 
| 6-Minute Walk | Participants are instructed to walk for 6 minutes. | Week 0, Week 9 and week 16 | 
| Spatiotemporal gait parameters | Gait parameters at self-selected pace will be collected on an electronic walkway. | Week 0, Week 9 and week 16 | 
| MS Walking Scale - 12 | The MSWS-12 consists of 12 items inquiring about the impact of MS on various aspects of walking. Score range is from 0 to 100, with higher scores indicating a worse outcome. | Week 0, Week 9 and week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gait analysis, Music therapy, Multiple sclerosis