Rhythmic Auditory Stimulation & Gait Training

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Gait Disorders, Neurologic
• Intervention / Treatment: Other: Gait Training; Other: Rhythmic auditory stimulation

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 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
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susan Linder, DPT; Phone Number: 216-445-9815; Email: linders@ccf.org
• Study Contact Backup: Name: Angela Miniard, MEd,LPC; Phone Number: 216-386-1153; Email: miniara@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Gait Training (GT) with Rhythmic Auditory Stimulation (RAS); 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; RAS, a Neurologic Music Therapy technique developed to utilize rhythm and timing cues to assist in improving the basic, intrinsic rhythmic movements of gait.; Other Names: RAS
OTHER: Gait training (GT) without Rhythmic Auditory Stimulation (RAS); 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; Continuous overground walking on a track for 30 minutes. Gait training will primarily consist of walking exercise under the supervision of an exercise physiologist.; Other Names: GT

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Consortium of Multiple Sclerosis Centers; MedRhythms, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 8, 2020
• Primary Completion (ACTUAL): November 7, 2022
• Study Completion (ACTUAL): November 7, 2022

Study Registration Dates

• First Submitted: March 11, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (ACTUAL): March 18, 2020

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Multiple sclerosis; Gait analysis; Music therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neurologic Manifestations; Multiple Sclerosis; Sclerosis; Nervous System Diseases; Gait Disorders, Neurologic
• Other Study ID Numbers: #19-1590

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No