Rhythmic Auditory Stimulation & Gait Training

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04314076
• Other study ID #: #19-1590
• Status: Completed
• Phase: N/A
• Start date: June 8, 2020
• Est. completion date: November 7, 2022

Study information

• Verified date: February 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 7, 2022
• Est. primary completion date: November 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Multiple Sclerosis
• Nervous System Diseases
• Sclerosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
The Cleveland Clinic	Consortium of Multiple Sclerosis Centers, MedRhythms, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	6-Minute Walk	Participants are instructed to walk for 6 minutes.	Week 0, Week 9 and week 16
Secondary	Spatiotemporal gait parameters	Gait parameters at self-selected pace will be collected on an electronic walkway.	Week 0, Week 9 and week 16
Secondary	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