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- Ensayo clínico NCT07685327
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
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Muhammad Ashar Rafi, PhD*
- Número de teléfono: 923083407837
- Correo electrónico: Ashar.rafi@uipt.iiui.edu.pk
Copia de seguridad de contactos de estudio
- Nombre: Muhammad Yaseen Khattak, MS-PPT
- Número de teléfono: 923115563552
- Correo electrónico: yaseenkhattak391@gmail.com
Ubicaciones de estudio
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Kpk
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Mansehra, Kpk, Pakistán, 21300
- Reclutamiento
- Helping hand Comprehansive Physical Rehabilitation Center Mansehra
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Contacto:
- Muhammad Yaseen Khattak, MS-PPT
- Número de teléfono: 03440957080
- Correo electrónico: yaseenkhattak391@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Fully Immersive Mixed Reality + Standard Physical Therapy
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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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.
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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Comparador activo: Standard Physical Therapy
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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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Comprehensive Coordination Scale (CCS)
Periodo de tiempo: Baseline, Week 4, and Week 8
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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.
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Baseline, Week 4, and Week 8
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Pediatric Balance Scale (PBS)
Periodo de tiempo: Baseline, Week 4, and Week 8
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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.
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Baseline, Week 4, and Week 8
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Muhammad Yaseen Khattak, MS-PPT, Ibadat International University, Islamabad
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IIUI/RERC/ADT/2026/01/214
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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