Comparative Study of Augmented Reality and Virtual Reality in Music Therapy Interventions for Individuals With Cerebral Palsy

NCT07596550 | Not Yet Recruiting

• 1 other identifier: 91871425.2.0000.0084
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the user experience of Augmented Reality (AR) and Virtual Reality (VR) applications during music therapy interventions in individuals with Cerebral Palsy aged 15 to 35 years with Gross Motor Function Classification System (GMFCS) level I-V. The main questions it aims to answer are: Does AR or VR result in lower levels of cybersickness as measured by the Simulator Sickness Questionnaire (SSQ)? Does AR or VR provide better usability, preference, and perceived ease of interaction? Researchers will compare AR and VR conditions to determine which technology results in lower cybersickness levels, higher usability scores, and greater user preference. Participants will: complete a pre-intervention SSQ assessment; engage in AR and VR sessions in a counterbalanced order using the Meta Quest 3 headset; explore each virtual environment for 5 minutes; perform motor tasks involving reaching and interacting with virtual musical objects (musical cubes representing musical notes: C-D-E-F-G-A-B); perform cognitive tasks involving identification and reproduction of musical note sequences guided by a therapist; perform percussion activities by following rhythmic patterns played by a therapist using virtual instruments; complete post-condition assessments after each session, including SSQ, System Usability Scale (SUS), preference, and reported difficulties.

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy; Augmented Reality; Virtual Reality; Mixed Reality; Music Therapy; User Experience; Usability; Cybersickness; System Usability Scale; Meta Quest 3; Motor Rehabilitation; Assistive Technology; Accessibility; Human-Computer Interaction

Outcome Measures

Primary Outcomes (1)

• User experience and usability of AR and VR environments

  User experience will be assessed through an adapted version of the System Usability Scale (SUS) and additional user-reported measures of interaction quality, ease of use, and confidence. The assessment captures perceived usability, learnability, need for assistance, and overall satisfaction with the system during interaction in both Augmented Reality (AR) and Virtual Reality (VR) conditions.

  Immediately after AR session and immediately after VR session

Secondary Outcomes (4)

• Cybersickness symptoms (adapted symptom scale)

  Baseline, immediately after the AR session, and immediately after the VR session

• Physical comfort and interaction quality (ISO 9241-400-based measures)

  Immediately after AR session and immediately after VR session

• User preference between AR and VR conditions

  Immediately after completion of both intervention sessions

• Reported difficulties and qualitative feedback

  Immediately after completion of both intervention sessions

Study Arms (2)

Augmented Reality (AR) Music Therapy

EXPERIMENTAL

Participants engage in music therapy activities using an augmented reality environment (GenVirtual) and delivered through the Meta Quest 3 with hand tracking. Activities include interaction with musical cubes and virtual percussion tasks designed to reduce fine motor demands and promote engagement.

Device: Augmented Reality Music Therapy Using GenVirtual

Virtual Reality (VR) Music Therapy

EXPERIMENTAL

Participants engage in music therapy activities using an virtual reality environment (GenVirtual) and delivered through the Meta Quest 3 with hand tracking. Activities include interaction with musical cubes and virtual percussion tasks designed to reduce fine motor demands and promote engagement.

Device: Virtual Reality Music Therapy Using GenVirtual

Interventions

Augmented Reality Music Therapy Using GenVirtual DEVICE

Augmented reality-based music therapy activities delivered through the GenVirtual application, developed in Unity 3D and used with the Meta Quest 3 headset with hand-tracking interaction. Participants interact with virtual musical cubes and percussion instruments through reaching movements and hand-based interaction.

Augmented Reality (AR) Music Therapy

Virtual Reality Music Therapy Using GenVirtual DEVICE

Virtual reality-based music therapy activities delivered through the GenVirtual application, developed in Unity 3D and used with the Meta Quest 3 headset with hand-tracking interaction. Participants interact with virtual musical cubes and percussion instruments through reaching movements and hand-based interaction.

Virtual Reality (VR) Music Therapy

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with a confirmed diagnosis of Cerebral Palsy
• Aged between 15 and 35 years
• Participants of any sex
• Cognitive ability compatible with participation in the study, determined by a minimum Intelligence Quotient (IQ) score established through the Wechsler Intelligence Scale for Children (WISC) or Wechsler Adult Intelligence Scale (WAIS)
• Ability to participate in immersive music therapy activities using hand-tracking interaction with the Meta Quest 3 headset

You may not qualify if:

• Failure to attend the second experimental session
• Withdrawal or interruption of participation in the study for any reason before completion of all study procedures
• Insufficient corrected visual acuity to adequately interact with the immersive system, verified through a simple visual screening assessment
• Failure to achieve the minimum Intelligence Quotient (IQ) score required for understanding the proposed tasks, as determined by the Wechsler Intelligence Scale for Children (WISC) or Wechsler Adult Intelligence Scale (WAIS) assessments

Sponsors & Collaborators

• Mackenzie Presbiterian University: lead

Study Sites (1)

Mackenzie Presbiterian University

São Paulo, São Paulo, 01302-907, Brazil

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Ana Grasielle D Correa, Ph.D

CONTACT

+55 11 97113-2466; ana.correa@mackenzie.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will complete both intervention conditions, Augmented Reality (AR) and Virtual Reality (VR), in a counterbalanced crossover design. The order of exposure will be alternated across participants to minimize sequence effects. The two experimental sessions will be conducted on separate days, approximately one week apart, with each participant serving as their own control for comparison of user experience, usability, cybersickness, preference, and reported difficulties.

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)