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Multiple SclerosisNCT07399262

Music-Augmented Rhythmic Gait Training in Multiple Sclerosis

A study testing Breathing and General Mobility Exercises, Music-Assisted Rhythmic Gait Training and Rhythmic Gait Training Without Music in people with Multiple Sclerosis and Rehabilitation, run by Biruni University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis, Rehabilitation
What is being tested?
Breathing and General Mobility Exercises, Music-Assisted Rhythmic Gait Training and Rhythmic Gait Training Without Music
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Jan 2026to 30 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Güzin Kaya Aytutuldu contact

05366265884

guzinkaya14@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Biruni University

    Istanbul, Zeytinburnu, 34015

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Music-Augmented Versus Non-Music Technology-Based Rhythmic Gait Training in Multiple Sclerosis: A Randomized Controlled Trial of Gait Performance and Clinical Outcomes

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.

Read the detailed description

Multiple sclerosis (MS) is a chronic, inflammatory, and demyelinating disease of the central nervous system that leads to impairments in motor and cognitive functions, with gait disturbances being among the most common and disabling symptoms. Walking impairments in individuals with MS substantially reduce quality of life and are frequently accompanied by balance deficits, fatigue, and decreased functional capacity, ultimately limiting independence in daily activities.

Recent evidence suggests that rhythmic auditory stimulation and music-based gait training can enhance motor control and walking performance by providing external temporal cues that facilitate movement coordination. In parallel, telerehabilitation has emerged as an effective and accessible rehabilitation approach, enabling supervised exercise delivery while reducing barriers related to transportation, cost, and long-term adherence.

In this randomized controlled trial, a total of 32 individuals with MS who have an Expanded Disability Status Scale (EDSS) score between 0 and 4 and a definite diagnosis according to the McDonald criteria will be recruited. Participants will be randomly allocated into two groups using computer-generated randomization. The intervention group (Group A) will perform rhythmic gait exercises accompanied by music, whereas the control group (Group B) will perform the same exercises without music. Both interventions will be delivered in a telerehabilitation format under the supervision of a physiotherapist.

The intervention program will last four weeks, with training sessions conducted four days per week. Primary and secondary outcome measures assessing walking performance, balance, fatigue, and cognitive function will be administered before and after the intervention period.

The primary objective of this study is to comparatively evaluate the effects of technology-based, music-assisted rhythmic gait training on motor outcomes in individuals with MS and to contribute high-quality scientific evidence to an area that remains underrepresented in the current rehabilitation literature.

Being tested
Breathing and General Mobility Exercises, Music-Assisted Rhythmic Gait Training, Rhythmic Gait Training Without Music
Keywords
Multiple Sclerosis, Rhythmic Gait Training, Music-Based Exercise, Telerehabilitation, Gait Performance
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Breathing and General Mobility ExercisesOther

    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.

  • Music-Assisted Rhythmic Gait TrainingOther

    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 Gait Training Without MusicOther

    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).

Study groups in NCT07399262
Study groupRoleWhat they receive
Rhythmic GaitTraining Group with MusicExperimentalParticipants 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.
Receives: Other: Breathing and General Mobility Exercises; Other: Music-Assisted Rhythmic Gait Training
Rhythmic Gait Training Without MusicActive comparatorParticipants 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.
Receives: Other: Breathing and General Mobility Exercises; Other: Rhythmic Gait Training Without Music

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline and immediately after intervention

Secondary outcomes (8)
  1. Two Minute Walk Test

    The Two-Minute Walk Test (2MWT) will be used to assess functional walking capacity and treatment response. The total distance walked within two minutes is recorded in meters. Vital signs are measured before and after the test. In this study, the 2MWT is preferred over the 6-Minute Walk Test due to its practicality, feasibility, and validated use in individuals with MS without inducing excessive fatigue

    Measured: Baseline and immediately after intervention

  2. Timed Up and Go Test

    In the Timed Up and Go Test, participants are instructed to stand up from a seated position, walk a distance of 3 meters, turn around a reference object, return to the chair, and sit down. The time required to complete the task is recorded in seconds. The test is performed three times, and the average time is used for analysis

    Measured: Baseline and immediately after intervention

  3. Step Length

    Kinovea® software (version 0.8.15) is used to perform objective and quantitative kinematic and spatiotemporal gait analysis from video recordings. The software enables the analysis of parameters such as step length, stride length, base of support, step width, cadence, walking speed, and step time (37).

    In this study, gait will be recorded using a camera positioned in the sagittal plane while participants walk a distance of 3 meters. Colored markers will be placed on the right and left heels to facilitate identification in the video recordings. Several gait cycles will be captured and analyzed independently using Kinovea software to determine step length (distance between consecutive heel strikes of opposite limbs), stride length (distance between consecutive heel strikes of the same limb), cadence (steps per minute), and bilateral step lengths (38-40). Walking speed (V) will be calculated using the formula:

    Measured: Baseline and immediately after intervention

  4. Stride Length

    Kinovea® software (version 0.8.15) is used to perform objective and quantitative kinematic and spatiotemporal gait analysis from video recordings. The software enables the analysis of parameters such as step length, stride length, base of support, step width, cadence, walking speed, and step time (37).

    In this study, gait will be recorded using a camera positioned in the sagittal plane while participants walk a distance of 3 meters. Colored markers will be placed on the right and left heels to facilitate identification in the video recordings. Several gait cycles will be captured and analyzed independently using Kinovea software to determine step length (distance between consecutive heel strikes of opposite limbs), stride length (distance between consecutive heel strikes of the same limb), cadence (steps per minute), and bilateral step lengths (38-40). Walking speed (V) will be calculated using the formula:

    Measured: Baseline and immediately after intervention

  5. Walking Speed

    Kinovea® software (version 0.8.15) is used to perform objective and quantitative kinematic and spatiotemporal gait analysis from video recordings. The software enables the analysis of parameters such as step length, stride length, base of support, step width, cadence, walking speed, and step time (37).

    In this study, gait will be recorded using a camera positioned in the sagittal plane while participants walk a distance of 3 meters. Colored markers will be placed on the right and left heels to facilitate identification in the video recordings. Several gait cycles will be captured and analyzed independently using Kinovea software to determine step length (distance between consecutive heel strikes of opposite limbs), stride length (distance between consecutive heel strikes of the same limb), cadence (steps per minute), and bilateral step lengths (38-40). Walking speed (V) will be calculated using the formula:

    Measured: Baseline and immediately after intervention

  6. Modified Fatigue Impact Scale

    The Modified Fatigue Impact Scale (MFIS) is a 21-item questionnaire designed to assess the impact of fatigue on physical, cognitive, and psychosocial functioning (41). Each item is scored on a 5-point Likert scale ranging from 0 (no problem) to 4 (severe problem). The total score ranges from 0 to 84, with higher scores indicating greater fatigue severity. Subscale scores for physical, cognitive, and psychosocial domains are calculated and summed to obtain the total score.

    Measured: Baseline and immediately after intervention

  7. The Four Square Step Test

    The Four Square Step Test evaluates the ability to change direction while stepping. Participants begin in Square 1 (upper left) and follow a predefined stepping sequence clockwise (Squares 1-2-4-3) and then counterclockwise (Squares 3-4-2-1). The physiotherapist demonstrates the test and allows practice trials if needed. If the participant loses balance, touches the assistive device, or fails to complete the sequence, the test is repeated. Two trials are recorded, and the best performance time is used for analysis. Timing begins when the first foot contacts Square 2 and ends when both feet return to Square 1

    Measured: Baseline and immediately after intervention

  8. BICAMS Battery

    The BICAMS battery includes the Symbol Digit Modalities Test (SDMT), California Verbal Learning Test-Second Edition (CVLT-II), and Brief Visuospatial Memory Test-Revised (BVMT-R). The battery was recommended in 2012 for monitoring cognitive function in individuals with MS, and its Turkish validity and reliability were established in 2017

    Measured: Baseline and immediately after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2026
  2. Study start20 Jan 2026
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07399262
Sponsor's protocol ID
Biruni.U
Status last verified
Feb 2026
First submitted
29 Jan 2026
Last updated
10 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 10516781
  • 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.

    PubMed 26254948
  • 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.

    PubMed 20643882

Questions about this trial

What is this clinical trial studying?

A study testing Breathing and General Mobility Exercises, Music-Assisted Rhythmic Gait Training and Rhythmic Gait Training Without Music in people with Multiple Sclerosis and Rehabilitation, run by Biruni University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Güzin Kaya Aytutuldu (05366265884, guzinkaya14@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gait Speed (time frame: Baseline and immediately after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07399262, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.

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