Comparing Mixed Reality and Physical Therapy to Improve Balance and Coordination in Adolescents With Spastic Diplegic Cerebral Palsy

NCT07685327 | Recruiting

• 1 other identifier: IIUI/RERC/ADT/2026/01/214
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to compare the effectiveness of fully immersive Mixed Reality (MR) combined with standard physical therapy versus standard physical therapy alone in improving balance and coordination among adolescents with spastic diplegic cerebral palsy. A total of 40 participants aged 10 to 19 years will be randomly assigned to one of two treatment groups. The intervention will be provided three times per week for eight weeks. Balance and coordination will be assessed before treatment, at four weeks, and after completion of the intervention using validated clinical outcome measures. The findings of this study may help determine whether immersive Mixed Reality can enhance rehabilitation outcomes in adolescents with cerebral palsy.

Conditions

Cerebral Palsy; Spastic Diplegic Cerebral Palsy

Keywords

Cerebral Palsy; Mixed Reality; Fully Immersive Mixed Reality; Pediatric Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Comprehensive Coordination Scale (CCS)

  The Comprehensive Coordination Scale (CCS) will be used to assess motor coordination in adolescents with spastic diplegic cerebral palsy. Scores will be compared between the intervention and control groups to determine the effect of the interventions on coordination.

  Baseline, Week 4, and Week 8

• Pediatric Balance Scale (PBS)

  The Pediatric Balance Scale (PBS) will be used to evaluate functional balance in adolescents with spastic diplegic cerebral palsy. Scores will be compared between the intervention and control groups to determine the effect of the interventions on balance.

  Baseline, Week 4, and Week 8

Study Arms (2)

Fully Immersive Mixed Reality + Standard Physical Therapy

EXPERIMENTAL

Participants assigned to the experimental arm will receive fully immersive Mixed Reality (MR) using the Meta Quest Pro platform in combination with standardized physical therapy. The MR intervention will include interactive applications designed to improve balance and coordination. Standard physiotherapy will include balance training, gait training, beam walking, wobble board exercises, cone weaving, stretching, and strengthening exercises. Treatment will be provided three sessions per week for eight weeks.

Device: Meta Quest Pro Mixed Reality System; Other: Standard Physical Therapy

Standard Physical Therapy

ACTIVE COMPARATOR

Participants assigned to the control arm will receive standardized physical therapy alone, including balance training, gait training, beam walking, wobble board exercises, cone weaving, stretching, strengthening exercises, patient education, and a home exercise program. Treatment will be provided three sessions per week for eight weeks.

Other: Standard Physical Therapy

Interventions

Meta Quest Pro Mixed Reality System DEVICE

Participants will receive fully immersive Mixed Reality rehabilitation using the Meta Quest Pro headset in combination with standardized physical therapy. The intervention includes interactive applications such as Beat Saber, Ball Balance, Run and Cycling, Running Monkeys, and Back to Subway Surfer. Treatment will be provided three sessions per week for eight weeks to improve balance and coordination in adolescents with spastic diplegic cerebral palsy.

Fully Immersive Mixed Reality + Standard Physical Therapy

Standard Physical Therapy OTHER

Participants will receive standardized physical therapy consisting of balance training, tandem gait exercises, beam walking, wobble board exercises, cone weaving, stretching, strengthening exercises, patient education, and a home exercise program. Treatment will be provided three sessions per week for eight weeks.

Fully Immersive Mixed Reality + Standard Physical Therapy; Standard Physical Therapy

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male and female participants.
• Adolescents aged 10 to 19 years.
• Clinically diagnosed with spastic diplegic cerebral palsy.
• Gross Motor Function Classification System (GMFCS) Levels I, II, or III.
• Pediatric Balance Scale (PBS) score greater than 35.
• Willing to participate in the study and provide written informed consent/assent with parental or legal guardian consent where applicable.

You may not qualify if:

• Cognitive impairment (MMSE score \<24).
• History of seizure disorders.
• Visual or hearing impairment that interferes with participation.
• Diagnosed psychological or psychiatric disorders.
• Any other medical condition that would prevent safe participation in the study.

Sponsors & Collaborators

• Ibadat International University, Islamabad: lead

Study Sites (1)

Helping hand Comprehansive Physical Rehabilitation Center Mansehra

Mansehra, Kpk, 21300, Pakistan

RECRUITING

Related Publications (1)

• Lee K, Oh H, Lee G. Fully Immersive Virtual Reality Game-Based Training for an Adolescent with Spastic Diplegic Cerebral Palsy: A Case Report. Children (Basel). 2022 Oct 3;9(10):1512. doi: 10.3390/children9101512.

  PMID: 36291448 RESULT

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

• Muhammad Yaseen Khattak, MS-PPT

  Ibadat International University, Islamabad

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Ashar Rafi, PhD*

CONTACT

923083407837; Ashar.rafi@uipt.iiui.edu.pk

Muhammad Yaseen Khattak, MS-PPT

CONTACT

923115563552; yaseenkhattak391@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a single-blinded randomized controlled trial. The participant will be blinded to group allocation throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of two parallel groups. The experimental group will receive fully immersive Mixed Reality combined with standard physical therapy, while the control group will receive standard physical therapy alone throughout the study period.

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: January 12, 2026
• Primary Completion: July 1, 2026
• Study Completion: August 1, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)