Comparative Study of Augmented Reality and Virtual Reality in Music Therapy Interventions for Individuals With Cerebral Palsy (HARMONY-CP)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: Augmented Reality Music Therapy Using GenVirtual; Device: Virtual Reality Music Therapy Using GenVirtual

Detailed Description

This study investigates the use of immersive technologies in music therapy for individuals with Cerebral Palsy, focusing on the comparative effects of Augmented Reality (AR) and Virtual Reality (VR) on user experience and interaction.

Individuals classified at Gross Motor Function Classification System (GMFCS) level I-V often present severe motor impairments that limit their ability to engage in conventional therapeutic activities. Music therapy has been shown to support cognitive and emotional engagement; however, traditional approaches may require adaptations to accommodate motor limitations. Immersive technologies such as AR and VR offer alternative interaction modalities that may enhance accessibility, engagement, and autonomy.

The study adopts a within-subject crossover design in which all participants are exposed to both AR and VR conditions in a counterbalanced order to minimize sequence effects. The experimental sessions are conducted on separate days, with one condition (AR or VR) performed first and the alternate condition performed approximately one week later to minimize carryover effects.

The intervention is delivered using the Meta Quest 3 headset, which supports hand-tracking interaction. A custom application, named GenVirtual, was developed in the Unity 3D environment to provide accessible and adaptive interaction for individuals with severe motor impairments. The system leverages hand-tracking to enable interaction without the need for physical controllers, reducing barriers related to fine motor control.

Each experimental session is structured into three phases: (1) initial familiarization with the immersive environment, (2) interaction with musical cubes representing musical notes, and (3) rhythmic interaction using virtual percussion instruments. The musical cubes are visually differentiated by color and correspond to the seven musical notes (C-D-E-F-G-A-B), allowing participants to perform structured tasks involving sequencing and auditory discrimination. In the percussion phase, participants reproduce rhythmic patterns demonstrated by a therapist, promoting synchronization, attention, and sensorimotor coordination.

The applications were designed to support both motor and cognitive engagement by integrating multimodal feedback (visual and auditory cues) and minimizing the need for precise fine motor control. The therapist provides guidance throughout the session, ensuring task comprehension and adapting the pace as needed based on participant performance.

Data collection focuses on subjective measures of user experience, including perceived usability, cybersickness symptoms, and interaction-related difficulties. The crossover design allows for direct comparison between AR and VR conditions within the same participants, reducing inter-subject variability and increasing sensitivity to detect differences between technologies.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana Grasielle D Correa, Ph.D; Phone Number: +55 11 97113-2466; Email: ana.correa@mackenzie.br

Study Locations

• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil, 01302-907
      • Mackenzie Presbiterian University
      • Contact: Ana Grasielle D Corrêa, Ph.D; Phone Number: +55 11 2114-8000; Email: ana.correa@mackenzie.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Augmented Reality (AR) Music Therapy; 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; 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.
Experimental: Virtual Reality (VR) Music Therapy; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cybersickness symptoms (adapted symptom scale)	Symptoms of cybersickness will be assessed using a self-reported symptom scale adapted from the Simulator Sickness Questionnaire (SSQ), including dizziness, nausea, fatigue, blurred vision, sweating, anxiety, and discomfort. Each symptom is rated on a scale of 0 to 10 (0 = none, 10 = maximum). The measurements will be used to compare the variation in symptoms between AR and VR conditions.	Baseline, immediately after the AR session, and immediately after the VR session
Physical comfort and interaction quality (ISO 9241-400-based measures)	Physical comfort, effort, fatigue, precision, and interaction quality will be assessed using items adapted from ISO 9241-400 guidelines. The instrument evaluates posture comfort, physical effort during hand-tracking interaction, naturalness of movements, system responsiveness, and interaction consistency.	Immediately after AR session and immediately after VR session
User preference between AR and VR conditions	Participant preference will be assessed after exposure to both conditions. Participants will indicate which environment (AR or VR) they preferred based on overall experience.	Immediately after completion of both intervention sessions
Reported difficulties and qualitative feedback	Participants will report perceived difficulties, frustration points, and positive aspects of interaction through structured questions and brief interviews. Additional observational notes from therapists may be recorded to identify usability barriers and interaction challenges.	Immediately after completion of both intervention sessions

Collaborators and Investigators

• Sponsor: Mackenzie Presbiterian University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Virtual Reality; Assistive Technology; Augmented Reality; Music Therapy; Usability; Motor Rehabilitation; Accessibility; Mixed Reality; User Experience; Human-Computer Interaction; System Usability Scale; Meta Quest 3; Cybersickness
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 91871425.2.0000.0084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No