Music-Augmented Versus Non-Music Technology-Based Rhythmic Gait Training in Multiple Sclerosis: A Randomized Controlled Trial of Gait Performance and Clinical Outcomes
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Biruni University
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Gait Speed
Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking 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.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Arms & Interventions
Rhythmic GaitTraining Group with Music
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.
Intervention: Breathing and General Mobility Exercises (Other)
Rhythmic GaitTraining Group with Music
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.
Intervention: Music-Assisted Rhythmic Gait Training (Other)
Rhythmic Gait Training Without Music
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.
Intervention: Breathing and General Mobility Exercises (Other)
Rhythmic Gait Training Without Music
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.
Intervention: Rhythmic Gait Training Without Music (Other)
Outcomes
Primary Outcomes
Gait Speed
Time Frame: Baseline and immediately after intervention
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
Secondary Outcomes
- 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)
- Modified Fatigue Impact Scale(Baseline and immediately after intervention)
- The Four Square Step Test(Baseline and immediately after intervention)
- BICAMS Battery(Baseline and immediately after intervention)
Investigators
Guzin Kaya Aytutuldu
Assistant Professor
Biruni University