NCT07010536

Effect of Virtual Reality-Based Music Therapy on Cognitive and Motor Skills in Subacute Stroke Patients

Effect of Immersive Virtual Reality-Based Music Therapy on Cognitive and Motor Skills in Subacute Stroke Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Suzan Aydın · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial aims to investigate the effects of immersive virtual reality-based music therapy on cognitive and motor functions in individuals aged 50 to 75 years with subacute stroke (between 2 weeks and 6 months post-stroke). Participants will be randomly assigned to either a control group receiving conventional physiotherapy or an experimental group receiving conventional physiotherapy plus virtual reality-based music therapy. 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.

Detailed description

This is a single-center, single bilind, randomized, controlled, prospective clinical trial designed to evaluate the effects of immersive virtual reality (VR)-based music therapy on cognitive functions, upper extremity motor skills, stroke impact, balance, and spatial neglect in patients with subacute stroke. The study targets individuals aged between 50 and 75 years who have experienced a stroke within the previous 2 weeks to 6 months. All participants will be recruited from Istanbul Aydın University VM Medical Park Hospital. 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

• Stroke
• Subacute Stroke
• Virtual Reality
• Immersive Virtual Reality
• Cognitive Dysfunction
• Motor Impairment

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2025-03-22
• Primary completion: 2025-07-20
• Completion: 2025-12-20
• First posted: 2025-06-08
• Last updated: 2025-06-08

Locations

1 site across 1 country: Turkey (Türkiye)