NCT04314076

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Multiple Sclerosis
• Gait Disorders, Neurologic

Interventions

Type	Name	Description
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	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.

Timeline

• Start date: 2020-06-08
• Primary completion: 2022-11-07
• Completion: 2022-11-07
• First posted: 2020-03-18
• Last updated: 2023-02-09

Locations

1 site across 1 country: United States