Music-Augmented Rhythmic Gait Training in Multiple Sclerosis

NCT07399262 | Recruiting

• 1 other identifier: Biruni.U
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to compare the effects of technology-based rhythmic gait training performed with and without music on walking performance and clinical outcomes in individuals with multiple sclerosis (MS). Thirty-two participants with mild to moderate disability will be randomly assigned to either a music-assisted rhythmic gait training group or a non-music control group, with both interventions delivered via telerehabilitation. Outcomes related to gait performance, balance, fatigue, and cognitive function will be assessed before and after a four-week intervention period.

Conditions

Multiple Sclerosis; Rehabilitation

Keywords

Multiple Sclerosis; Rhythmic Gait Training; Music-Based Exercise; Telerehabilitation; Gait Performance

Outcome Measures

Primary Outcomes (1)

• Gait Speed

  Walking speed is the primary outcome measure of the study and will be assessed using the Timed 25-Foot Walk Test (T25FW). In this test, participants are instructed to walk a distance of 7.62 m (25 feet) as quickly and safely as possible, without running. The completion time is recorded in seconds. Two trials are performed, and the average of the two trials is recorded as the T25FW score. The T25FW is one of the most well-established and widely used measures for assessing gait impairment and walking speed in individuals with multiple sclerosis

  Baseline and immediately after intervention

Secondary Outcomes (8)

• Two Minute Walk Test

  Baseline and immediately after intervention

• Timed Up and Go Test

  Baseline and immediately after intervention

• Step Length

  Baseline and immediately after intervention

• Stride Length

  Baseline and immediately after intervention

• Walking Speed

  Baseline and immediately after intervention

Study Arms (2)

Rhythmic GaitTraining Group with Music

EXPERIMENTAL

Participants in this group will perform technology-based rhythmic gait exercises accompanied by music. The intervention will be delivered via telerehabilitation under the supervision of a physiotherapist, four days per week for four weeks.

Other: Breathing and General Mobility Exercises; Other: Music-Assisted Rhythmic Gait Training

Rhythmic Gait Training Without Music

ACTIVE COMPARATOR

Participants in this group will perform the same technology-based rhythmic gait exercises without music. The intervention will be delivered via telerehabilitation under the supervision of a physiotherapist, four days per week for four weeks.

Other: Breathing and General Mobility Exercises; Other: Rhythmic Gait Training Without Music

Interventions

Breathing and General Mobility Exercises OTHER

rticipants will perform standardized breathing exercises and general mobility exercises. These exercises will be delivered in the same telerehabilitation format and supervised by a physiotherapist.

Rhythmic Gait Training Without Music; Rhythmic GaitTraining Group with Music

Music-Assisted Rhythmic Gait Training OTHER

Participants will perform rhythmic gait training accompanied by music. The training will be delivered via telerehabilitation with real-time supervision through videoconferencing. Sessions will be conducted four days per week for four weeks. Gait training will be guided using instructional videos presented with music accompaniment.

Rhythmic GaitTraining Group with Music

Rhythmic Gait Training Without Music OTHER

Participants will perform the same rhythmic gait training program without music. The training will be delivered via telerehabilitation with real-time supervision through videoconferencing. Sessions will be conducted four days per week for four weeks. Gait training will be guided using instructional videos presented without music (silent).

Rhythmic Gait Training Without Music

Eligibility Criteria

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

You may qualify if:

• Expanded Disability Status Scale (EDSS) score between 0 and 4.0
• Access to the internet via a high-speed smartphone or computer
• A score of at least 21 on the Montreal Cognitive Assessment (MoCA)
• Functional Ambulation Scale score of Stage 3 or higher

You may not qualify if:

• Presence of hearing or visual impairments
• Current participation in any structured exercise program
• Presence of other neurological, cardiovascular, or orthopedic disorders
• History of MS relapse or change in disease-modifying treatment within the last 6 months
• Physical conditions preventing safe participation in the exercise program
• Comorbid conditions that adversely affect oxygen transport (e.g., severe anemia, peripheral arterial disease)

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Biruni University

Istanbul, Zeytinburnu, 34015, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Benedetti MG, Piperno R, Simoncini L, Bonato P, Tonini A, Giannini S. Gait abnormalities in minimally impaired multiple sclerosis patients. Mult Scler. 1999 Oct;5(5):363-8. doi: 10.1177/135245859900500510.

  PMID: 10516781 BACKGROUND

• Ehde DM, Elzea JL, Verrall AM, Gibbons LE, Smith AE, Amtmann D. Efficacy of a Telephone-Delivered Self-Management Intervention for Persons With Multiple Sclerosis: A Randomized Controlled Trial With a One-Year Follow-Up. Arch Phys Med Rehabil. 2015 Nov;96(11):1945-58.e2. doi: 10.1016/j.apmr.2015.07.015. Epub 2015 Aug 6.

  PMID: 26254948 BACKGROUND

• Conklyn D, Stough D, Novak E, Paczak S, Chemali K, Bethoux F. A home-based walking program using rhythmic auditory stimulation improves gait performance in patients with multiple sclerosis: a pilot study. Neurorehabil Neural Repair. 2010 Nov-Dec;24(9):835-42. doi: 10.1177/1545968310372139. Epub 2010 Jul 19.

  PMID: 20643882 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Respiration

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Guzin Kaya Aytutuldu

  Biruni University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Güzin Kaya Aytutuldu

CONTACT

05366265884; guzinkaya14@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is a two-arm, parallel-group, randomized controlled trial comparing music-assisted rhythmic gait training with non-music rhythmic gait training, conducted without masking due to the nature of the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study is a two-arm, parallel-group, randomized controlled trial comparing music-assisted rhythmic gait training with non-music rhythmic gait training, conducted without masking due to the nature of the interventions.

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 10, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)