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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Meta 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.
• Другое Standard 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.

Первичные конечные точки

• Comprehensive Coordination Scale (CCS) [Срок оценки: Baseline, Week 4, and Week 8]
• Pediatric Balance Scale (PBS) [Срок оценки: Baseline, Week 4, and Week 8]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Helping hand Comprehansive Physical Rehabilitation Center Mansehra — Mansehra

Публикации

• 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

Идентификаторы

NCT: NCT07685327 · IIUI/RERC/ADT/2026/01/214

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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