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Completed

NCT Number: NCT04314076

Rhythmic Auditory Stimulation & Gait Training

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Gait Disorders, Neurologic Immune System Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rhythmic Auditory Stimulation

Other

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

Gait Training

Other

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

Primary outcomes

  1. Number of patients with adverse events

    Time frame: through study completion, up to 16 weeks

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

  2. Percentage of training sessions missed.

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

    Training session attendance will be tracked as an indicator of feasibility throughout the treatment period.

Secondary outcomes

  1. Timed 25 Foot Walk

    Time frame: Week 0, Week 9 and week 16

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

  2. 6-Minute Walk

    Time frame: Week 0, Week 9 and week 16

    Participants are instructed to walk for 6 minutes.

  3. Spatiotemporal gait parameters

    Time frame: Week 0, Week 9 and week 16

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

  4. MS Walking Scale - 12

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Consortium of Multiple Sclerosis Centers
  • MedRhythms, Inc.

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 18, 2020
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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