Music-Augmented Rhythmic Gait Training in Multiple Sclerosis

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Breathing and General Mobility Exercises
  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.
• Другое Music-Assisted Rhythmic Gait Training
  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.
• Другое Rhythmic Gait Training Without Music
  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).

Первичные конечные точки

• Gait Speed [Срок оценки: Baseline and immediately after intervention]

Вторичные конечные точки (8)

• Two Minute Walk Test [Срок оценки: Baseline and immediately after intervention]
• Timed Up and Go Test [Срок оценки: Baseline and immediately after intervention]
• Step Length [Срок оценки: Baseline and immediately after intervention]
• Stride Length [Срок оценки: Baseline and immediately after intervention]
• Walking Speed [Срок оценки: Baseline and immediately after intervention]
• Modified Fatigue Impact Scale [Срок оценки: Baseline and immediately after intervention]
• The Four Square Step Test [Срок оценки: Baseline and immediately after intervention]
• BICAMS Battery [Срок оценки: Baseline and immediately after intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Biruni University — Istanbul

Публикации

• 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
• 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
• 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

Идентификаторы

NCT: NCT07399262 · Biruni.U

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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