Music-Augmented Rhythmic Gait Training in Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBiruni University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Expanded Disability Status Scale (EDSS) score between 0 and 4.0
Disqualifiers
Presence of hearing or visual impairments
Trial design
Design model
Parallel
Treatments tested in this trial
Breathing and General Mobility Exercises
Other interventionrticipants 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 Training
Other interventionParticipants 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 Music
Other interventionParticipants 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).
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Rhythmic GaitTraining Group with MusicExperimental treatment 2 interventions
Group B: Rhythmic Gait Training Without MusicActive comparator 2 interventions
Trial outcomes
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
Time frame
Baseline and immediately after interventionSecondary outcomes
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
Time frame
Baseline and immediately after intervention2
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
Time frame
Baseline and immediately after intervention3
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:
Time frame
Baseline and immediately after intervention4
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:
Time frame
Baseline and immediately after interventionSponsors and contacts
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Source ClinicalTrials.gov