Rhythmic Auditory Stimulation & Gait Training

NCT04314076 | Completed

• 1 other identifier: #19-1590
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Gait Disorders, Neurologic

Keywords

Gait analysis; Music therapy; Multiple sclerosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Timed 25 Foot Walk

  Week 0, Week 9 and week 16

• 6-Minute Walk

  Week 0, Week 9 and week 16

• Spatiotemporal gait parameters

  Week 0, Week 9 and week 16

• MS Walking Scale - 12

  Week 0, Week 9 and week 16

Study Arms (2)

Gait Training (GT) with Rhythmic Auditory Stimulation (RAS)

ACTIVE COMPARATOR

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

Gait training (GT) without Rhythmic Auditory Stimulation (RAS)

OTHER

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

Interventions

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.

Also known as: RAS

Gait Training (GT) with Rhythmic Auditory Stimulation (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.

Also known as: GT

Gait training (GT) without Rhythmic Auditory Stimulation (RAS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Consortium of Multiple Sclerosis Centers: collaborator
• MedRhythms, Inc.: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Francois Bethoux, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A blinded examiner will be used to perform the gait analysis, 6 minute walk , and timed 25 foot walk
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of PM&R,

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

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 18, 2020
• Study Start: June 8, 2020
• Primary Completion: November 7, 2022
• Study Completion: November 7, 2022
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)