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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.
erebral palsy (CP) is one of the most common neurological disorders affecting movement, balance, posture, and coordination in children and adolescents. Spastic diplegic cerebral palsy is characterized by increased muscle tone predominantly affecting the lower limbs, resulting in impaired balance, reduced coordination, and limitations in functional mobility. Conventional physical therapy is considered the standard rehabilitation approach; however, patient motivation and treatment adherence may limit its effectiveness.
Mixed Reality (MR) technology provides an immersive and interactive rehabilitation environment that combines virtual and real-world elements, enabling repetitive, task-oriented training with real-time feedback. Such interventions may enhance motor learning, neuroplasticity, patient engagement, and functional recovery. Despite promising evidence regarding immersive virtual reality interventions, limited randomized controlled trials have compared fully immersive Mixed Reality with conventional physical therapy in adolescents with spastic diplegic cerebral palsy.
This single-blinded randomized controlled trial aims to compare the effectiveness of fully immersive Mixed Reality 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 10-19 years who meet the eligibility criteria will be recruited and randomly allocated into two equal groups. Group A will receive fully immersive Mixed Reality training using the Meta Quest Pro platform in combination with standardized physical therapy, while Group B will receive standardized physical therapy alone. Both groups will receive treatment three sessions per week for eight weeks.
Outcome assessments will be performed at baseline, after four weeks, and after completion of the eight-week intervention. Balance will be evaluated using the Pediatric Balance Scale (PBS), while coordination will be assessed using the Comprehensive Coordination Scale (CCS). The findings of this study will provide evidence regarding the effectiveness of fully immersive Mixed Reality as an adjunct to conventional physical therapy and may contribute to improving rehabilitation strategies for adolescents with spastic diplegic cerebral palsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muhammad Ashar Rafi, PhD* | Contact | 923083407837 | Ashar.rafi@uipt.iiui.edu.pk | |
| Muhammad Yaseen Khattak, MS-PPT | Contact | 923115563552 | yaseenkhattak391@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Muhammad Yaseen Khattak, MS-PPT | Ibadat International University, Islamabad | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helping hand Comprehansive Physical Rehabilitation Center Mansehra | Recruiting | Mansehra | Kpk | 21300 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36291448 | Result | 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. |
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Individual participant data (IPD) will not be made publicly available because of participant confidentiality, privacy considerations, and institutional policies.
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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.
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This is a single-blinded randomized controlled trial. The participant will be blinded to group allocation throughout the study.
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| 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. |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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