Rhythmic Auditory Stimulation & Gait Training

The Cleveland Clinic24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Multiple Sclerosis Gait Disorders, Neurologic

Interventions

Rhythmic auditory stimulationOTHER

RAS, a Neurologic Music Therapy technique developed to utilize rhythm and timing cues to assist in improving the basic, intrinsic rhythmic movements of gait.

Gait TrainingOTHER

Continuous overground walking on a track for 30 minutes. Gait training will primarily consist of walking exercise under the supervision of an exercise physiologist.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Number of patients with adverse events

Adverse events will be collected throughout the study period to assess treatment safety.

Time frame: 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.

Time frame: through end of treatment, up to 9 weeks

Secondary Outcomes

Timed 25 Foot Walk

Participants are instructed to walk as fast as possible but safely on a 25-foot straight course.

Time frame: Week 0, Week 9 and week 16

6-Minute Walk

Participants are instructed to walk for 6 minutes.

Time frame: Week 0, Week 9 and week 16

Spatiotemporal gait parameters

Gait parameters at self-selected pace will be collected on an electronic walkway.

Time frame: 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.

Time frame: Week 0, Week 9 and week 16

Data from ClinicalTrials.gov

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