Effect of Virtual Reality-Based Music Therapy on Cognitive and Motor Skills in Subacute Stroke Patients
NCT ID: NCT07010536
Last Updated: 2025-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-03-22
2025-12-20
Brief Summary
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The study will assess cognitive performance, upper extremity motor skills, stroke impact, balance, and spatial neglect before and after a 6-week intervention. All participants will be treated at Istanbul Aydın University VM Medical Park Hospital. The study has been approved by the ethics committee, and written informed consent will be obtained from all participants.
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Detailed Description
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Participants will be stratified based on the side of hemispheric damage (right or left) and randomized into two equal groups (n=15 per group). The control group will receive conventional physiotherapy and rehabilitation 5 days per week for 6 weeks. The experimental group will receive the same conventional physiotherapy program along with additional immersive VR-based music therapy sessions twice a week. These VR sessions involve rhythm-based and music-supported tasks delivered through Oculus Quest 2 applications, including Ocean Rift and PianoVision.
Assessments will be performed at baseline and after the 6-week intervention period. Cognitive function will be assessed using standardized neuropsychological tools, and motor function will be evaluated through established stroke motor recovery scales. The Virtual Reality Sickness Questionnaire (VRSQ) will be administered after the first VR session to monitor adverse effects such as dizziness or nausea.
This trial adopts a stratified randomization method to enhance internal validity by balancing brain hemisphere involvement across groups. A power analysis conducted using G\*Power (version 3.1) determined a sample size of 30 participants based on an effect size reported by Fan et al. (2024), with 95% power and α=0.05. The study protocol has been approved by the Non-Interventional Research Ethics Committee of Üsküdar University (Approval No: 61351342/020-1000, Date: March 27, 2025). Written informed consent will be obtained from all participants before enrollment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Conventional Physiotherapy and Rehabilitation Group
Participants in the control arm will receive conventional physiotherapy and rehabilitation exercises five days per week for six weeks, with sessions lasting approximately 60 minutes. The program includes:
Strengthening exercises for upper and lower extremities
Resistance training
Aerobic exercises
Basic and assisted parallel bar walking
Skill courses on different surfaces
Balance exercises on stable and unstable surfaces
Static and dynamic balance training
Fine motor skill exercises
Weight transfer exercises aimed at improving postural stability
Exercises will be tailored to individual patient capabilities and performed in various positions including standing, sitting, four-point kneeling, supine, and prone. The difficulty level will be adjusted based on patient performance and functional status.
Conventional Physiotherapy and Rehabilitation
Participants will receive conventional physiotherapy and rehabilitation exercises as follows:
Upper and lower extremity strengthening exercises
Resistance training exercises
Aerobic exercises
Basic and assisted parallel bar walking
Skill courses on various surfaces
Training on stable and unstable surfaces
Static and dynamic balance exercises
Fine motor skill exercises
Weight transfer exercises to improve postural stability
Exercises will be performed according to the patient's condition in standing, sitting, four-point kneeling, supine, and prone positions.
Exercise difficulty will be adjusted based on the patient's performance and functional level.
Sessions will be 60 minutes long, 5 days per week, for 6 weeks.
VR-Based Music Therapy Group
Participants in the experimental arm will receive conventional physiotherapy and rehabilitation exercises five days per week for six weeks, each session lasting approximately 60 minutes. In addition to this, they will undergo immersive virtual reality (VR)-based music therapy sessions twice a week for 30 minutes per session over the same six-week period.
The VR therapy is administered under the supervision of a licensed physiotherapist using the Oculus Quest 2 headset. The intervention includes three main components:
Rhythm Exercises: Participants will engage in rhythm training by following clapping patterns streamed from the Brooklyn Music Factory YouTube channel, progressing from levels 1 to 4. During these exercises, participants clap their hands on a table to maintain the rhythm, which aims to improve motor coordination and timing.
PianoVision Application: A virtual piano that utilizes hand-tracking technology to allow participants to play without physical controllers. The pian
VR-Based Music Therapy
VR-Based Music Therapy Protocol:
Participants undergo immersive VR sessions twice weekly for 6 weeks, each lasting 30 minutes, supervised by a physiotherapist. Each session includes three 10-minute activities with 2-minute breaks:
Rhythm Exercises: Participants follow tempo by clapping on a table while watching Brooklyn Music Factory YouTube videos played within the VR headset (levels 1-4), progressing weekly.
Ocean Rift: Exploration of calming underwater environments with marine life to enhance relaxation, attention, and cognition.
PianoVision: Virtual piano exercises using hand tracking with the unaffected hand; difficulty increases from levels 0 to 4.
Conventional Physiotherapy and Rehabilitation
Participants will receive conventional physiotherapy and rehabilitation exercises as follows:
Upper and lower extremity strengthening exercises
Resistance training exercises
Aerobic exercises
Basic and assisted parallel bar walking
Skill courses on various surfaces
Training on stable and unstable surfaces
Static and dynamic balance exercises
Fine motor skill exercises
Weight transfer exercises to improve postural stability
Exercises will be performed according to the patient's condition in standing, sitting, four-point kneeling, supine, and prone positions.
Exercise difficulty will be adjusted based on the patient's performance and functional level.
Sessions will be 60 minutes long, 5 days per week, for 6 weeks.
Interventions
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VR-Based Music Therapy
VR-Based Music Therapy Protocol:
Participants undergo immersive VR sessions twice weekly for 6 weeks, each lasting 30 minutes, supervised by a physiotherapist. Each session includes three 10-minute activities with 2-minute breaks:
Rhythm Exercises: Participants follow tempo by clapping on a table while watching Brooklyn Music Factory YouTube videos played within the VR headset (levels 1-4), progressing weekly.
Ocean Rift: Exploration of calming underwater environments with marine life to enhance relaxation, attention, and cognition.
PianoVision: Virtual piano exercises using hand tracking with the unaffected hand; difficulty increases from levels 0 to 4.
Conventional Physiotherapy and Rehabilitation
Participants will receive conventional physiotherapy and rehabilitation exercises as follows:
Upper and lower extremity strengthening exercises
Resistance training exercises
Aerobic exercises
Basic and assisted parallel bar walking
Skill courses on various surfaces
Training on stable and unstable surfaces
Static and dynamic balance exercises
Fine motor skill exercises
Weight transfer exercises to improve postural stability
Exercises will be performed according to the patient's condition in standing, sitting, four-point kneeling, supine, and prone positions.
Exercise difficulty will be adjusted based on the patient's performance and functional level.
Sessions will be 60 minutes long, 5 days per week, for 6 weeks.
Eligibility Criteria
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Inclusion Criteria
* Age between 50 and 75 years
* Stroke onset more than 2 weeks and less than 6 months prior
* Diagnosis of unilateral hemiplegic stroke
* Preserved understanding, hearing, and speech abilities sufficient to engage with virtual reality games
Exclusion Criteria
* Wheelchair use or inability to sit in a chair
* Cognitive impairment preventing comprehension of study procedures
* Hearing loss
* Severe visual impairment
* Refusal to participate in the study
* Epilepsy
* Migraine with aura
* History of motion sickness
50 Years
75 Years
ALL
No
Sponsors
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Suzan Aydın
OTHER
Responsible Party
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Suzan Aydın
Principal Investigator, Physiotherapist, Lecturer and Ph.D. Candidate in Physical Therapy and Rehabilitation
Principal Investigators
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Selen GÜR ÖZMEN, Associate Professor
Role: STUDY_DIRECTOR
Bahçeşehir University
Locations
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Istanbul Aydin University VM Medical Park Hospital
Istanbul, Istanbul, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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61351342/020-1000
Identifier Type: -
Identifier Source: org_study_id
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