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

Suzan Aydın

Status: Enrolling

Conditions: Stroke; Subacute Stroke; Motor Impairment; Cognitive Dysfunction; Immersive Virtual Reality; Virtual Reality

Treatments: Behavioral: VR-Based Music Therapy; Behavioral: Conventional Physiotherapy and Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT07010536

61351342/020-1000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Voluntary participation
• 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

• Medically unstable condition
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Conventional Physiotherapy and Rehabilitation Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Conventional Physiotherapy and Rehabilitation

VR-Based Music Therapy Group

Experimental group

Description:

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

Treatment:

Behavioral: Conventional Physiotherapy and Rehabilitation

Behavioral: VR-Based Music Therapy