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

Effect Of Fully Immersive Mixed Reality Versus Standard Physical Therapy For Improving Balance And Coordination In Adolescent With Spastic Diplegic Cerebral Palsy" A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07685327
Enrollment
40
Registered
2026-07-06
Start date
2026-01-12
Completion date
2026-08-01
Last updated
2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Spastic Diplegic Cerebral Palsy

Keywords

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

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.

Detailed description

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.

Interventions

DEVICEMeta Quest Pro Mixed Reality System

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.

OTHERStandard Physical Therapy

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.

Sponsors

Ibadat International University, Islamabad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

This is a single-blinded randomized controlled trial. The participant will be blinded to group allocation throughout the study.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
10 Years to 19 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Comprehensive Coordination Scale (CCS)Baseline, Week 4, and Week 8The 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.
Pediatric Balance Scale (PBS)Baseline, Week 4, and Week 8The 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.

Countries

Pakistan

Contacts

CONTACTMuhammad Ashar Rafi, PhD*
Ashar.rafi@uipt.iiui.edu.pk923083407837
CONTACTMuhammad Yaseen Khattak, MS-PPT
yaseenkhattak391@gmail.com923115563552
PRINCIPAL_INVESTIGATORMuhammad Yaseen Khattak, MS-PPT

Ibadat International University, Islamabad

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026