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

Official title

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

Overview

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.

Interventions

• 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 enha
• 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 conditio

Primary outcome measures

• Change from Baseline in Global Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA) at 6 Weeks [Time frame: Baseline and 6 weeks after the start of intervention]
• Change from Baseline in Visual Memory as Assessed by the Benton Visual Retention Test - Form F at 6 Weeks [Time frame: Baseline and 6 weeks after the intervention]
• Change from Baseline in Working Memory Performance as Assessed by the Digit Span Test at 6 Weeks [Time frame: Baseline and 6 weeks after the intervention]
• Change from Baseline in Executive Function as Assessed by the Wisconsin Card Sorting Test (WCST) at 6 Weeks [Time frame: Baseline and 6 weeks after the intervention]
• Change from Baseline in Upper Extremity Motor Function as Assessed by the Fugl-Meyer Assessment of Upper Extremity (FMA-UE) at 6 Weeks [Time frame: Baseline and 6 weeks after the start of intervention]

Secondary outcome measures (3)

• Change from Baseline in Balance Performance as Assessed by the Berg Balance Scale (BBS) at 6 Weeks [Time frame: Baseline and 6 weeks after the start of intervention]
• Change from Baseline in Motor Recovery Assessed by Brunnstrom Staging at 6 Weeks [Time frame: Baseline and 6 weeks after the start of intervention]
• Change from Baseline in Spatial Neglect Severity as Assessed by the Star Cancellation Test at 6 Weeks [Time frame: Baseline and 6 weeks (only for participants with spatial neglect at baseline)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Istanbul Aydin University VM Medical Park Hospital — Istanbul

Identifiers

NCT: NCT07010536 · 61351342/020-1000

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗