Rhythmic Auditory Stimulation & Gait Training

Sponsor

The Cleveland Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT04314076

Collaborator

Consortium of Multiple Sclerosis Centers (Other), MedRhythms, Inc. (Industry)

Enrollment

Location

Arms

30.8

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis Gait Disorders, Neurologic	Other: Rythmic auditory stimulation Other: Gait Training	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

a single blind parallel-group pilot randomized controlled trial comparing rhythmic auditory stimulation (RAS) with gait training to gait training without RAS.a single blind parallel-group pilot randomized controlled trial comparing rhythmic auditory stimulation (RAS) with gait training to gait training without RAS.

Masking:

Single (Outcomes Assessor)

Masking Description:

A blinded examiner will be used to perform the gait analysis, 6 minute walk , and timed 25 foot walk

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jun 8, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Gait Training (GT) with Rythmic 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: Rythmic 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 Rythmic 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

Arm

Intervention/Treatment

Active Comparator: Gait Training (GT) with Rythmic 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: Rythmic 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 Rythmic 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:

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Timed 25 Foot Walk [Week 0, Week 9 and week 16]
Participants are instructed to walk as fast as possible but safely on a 25-foot straight course.
6-Minute Walk [Week 0, Week 9 and week 16]
Participants are instructed to walk for 6 minutes.
Spatiotemporal gait parameters [Week 0, Week 9 and week 16]
Gait parameters at self-selected pace will be collected on an electronic walkway.
MS Walking Scale - 12 [Week 0, Week 9 and week 16]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.