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

NCT07010536 | Recruiting

• 1 other identifier: 61351342/020-1000
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Stroke; Music Therapy; Virtual Reality; Cognition Disorders; Motor Skills Disorders; Postural Balance

Outcome Measures

Primary Outcomes (5)

• Change from Baseline in Global Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA) at 6 Weeks

  Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA), a standardized screening tool for global cognitive functioning. The assessment was conducted face-to-face by a trained evaluator. The MoCA consists of tasks evaluating memory, attention, executive functions, language, visuospatial skills, abstraction, calculation, and orientation. Scores range from 0 to 30. Higher scores indicate better cognitive performance. A score of 26 or higher is generally considered normal.

  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

  Visual memory was evaluated using the Benton Visual Retention Test (BVRT), Form F, a standardized neuropsychological test that assesses short-term visual memory, visual perception, and visuoconstructive skills. In this version, participants were shown 15 geometric designs, each for 10 seconds, and were instructed to reproduce each design from memory immediately after viewing. Each figure was scored based on established accuracy criteria. The outcome measure was the total number of correctly reproduced designs, with scores ranging from 0 to 15. Higher scores indicate better visual memory performance. Increased errors may reflect difficulties in memory, attention, or visual-spatial processing.

  Baseline and 6 weeks after the intervention

• Change from Baseline in Working Memory Performance as Assessed by the Digit Span Test at 6 Weeks

  Working memory was measured using the Digit Span subtest from the Wechsler Adult Intelligence Scale. The test consists of forward and backward repetition of digit sequences. Participants were asked to repeat sequences in the same order (forward) and reverse order (backward). Each correct sequence was scored, and the total score was recorded. Scores typically range from 0 to 30. Higher scores reflect greater working memory capacity.

  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

  Executive function was assessed using the Wisconsin Card Sorting Test (WCST), which evaluates cognitive flexibility and problem-solving. Participants were required to match cards based on undisclosed rules and adapt as the rules changed. The outcome measure is the number of correct categories completed. The maximum number of categories is 6. Higher scores reflect better executive functioning.

  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

  Motor function of the upper limb will be assessed using the Fugl-Meyer Assessment of Upper Extremity (FMA-UE), a validated and widely used scale in stroke rehabilitation. The FMA-UE evaluates reflex activity, volitional movement within and out of synergy, grasp, coordination, and speed. Scores range from 0 to 66, with higher scores indicating better motor function.

  Baseline and 6 weeks after the start of intervention

Secondary Outcomes (3)

• Change from Baseline in Balance Performance as Assessed by the Berg Balance Scale (BBS) at 6 Weeks

  Baseline and 6 weeks after the start of intervention

• Change from Baseline in Motor Recovery Assessed by Brunnstrom Staging at 6 Weeks

  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

  Baseline and 6 weeks (only for participants with spatial neglect at baseline)

Other Outcomes (1)

• Virtual Reality Sickness Score After First Session as Assessed by the Virtual Reality Sickness Questionnaire (VRSQ)

  After first VR session (Week 1)

Study Arms (2)

Conventional Physiotherapy and Rehabilitation Group

ACTIVE COMPARATOR

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.

Behavioral: Conventional Physiotherapy and Rehabilitation

VR-Based Music Therapy Group

EXPERIMENTAL

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

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

Interventions

VR-Based Music Therapy BEHAVIORAL

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.

VR-Based Music Therapy Group

Conventional Physiotherapy and Rehabilitation BEHAVIORAL

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.

Conventional Physiotherapy and Rehabilitation Group; VR-Based Music Therapy Group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Suzan Aydın: lead

Study Sites (1)

Istanbul Aydin University VM Medical Park Hospital

Istanbul, Istanbul, 34149, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke; Cognitive Dysfunction; Cognition Disorders; Motor Skills Disorders

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Selen GÜR ÖZMEN, Associate Professor

  Bahçeşehir University

  STUDY DIRECTOR

Central Study Contacts

Suzan Aydın, Ph.D. (c)

CONTACT

+90 212 422 44 00; suzanaltnkeser@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are blinded to group allocation. Participants and care providers are not blinded due to the nature of the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Physiotherapist, Lecturer and Ph.D. Candidate in Physical Therapy and Rehabilitation

Model Details: Participants will be randomly assigned to two parallel groups: a control group receiving only conventional physiotherapy, and an experimental group receiving conventional physiotherapy combined with immersive virtual reality-based music therapy. Both groups will receive interventions for 6 weeks, and outcomes will be compared between groups.

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 8, 2025
• Study Start: March 22, 2025
• Primary Completion: July 20, 2025
• Study Completion: December 20, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)