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Sensory-Motor Integration Versus Virtual Reality-Based Exercise in Children With Cerebral Palsy

17 de septiembre de 2026 actualizado por: Yeditepe University

Comparative Clinical Effectiveness of Sensory-Motor Integration and Virtual Reality-Based Exercise Programs for Enhancing Functional Mobility in Children With Cerebral Palsy: Strengthening Steps Through Play and Technology

This study aims to compare the clinical effects of a sensory-motor integration-based exercise program and a virtual reality-based exercise program on gross motor function, balance, and functional mobility in children with cerebral palsy. Participants will be randomly assigned to one of two groups. Both groups will continue to receive standard conventional physiotherapy. In addition, one group will receive a structured sensory-motor integration-based exercise program, while the other group will receive a Nintendo Wii Sports-based virtual reality exercise program. The intervention period will last 16 weeks, with two sessions per week. Outcomes will be assessed before and after the intervention using standardized clinical measures.

Descripción general del estudio

Descripción detallada

Cerebral palsy is a non-progressive neurodevelopmental condition characterized by permanent impairments in movement, posture, and motor function. Children with cerebral palsy may experience limitations in postural control, balance, motor planning, sensory processing, functional mobility, and participation in physical activity. Conventional physiotherapy is widely used in the rehabilitation of children with cerebral palsy and commonly includes tone regulation, stretching, strengthening, balance training, aerobic exercises, and functional activity training. However, additional rehabilitation approaches may be needed to support multidimensional motor and functional outcomes.

This study is designed as a two-arm, randomized controlled, parallel-group, prospective clinical intervention study. The aim is to compare the effects of two adjunctive rehabilitation approaches added to standard conventional physiotherapy: a Sensory-Motor Integration-Based Exercise Program and a Virtual Reality-Based Exercise Program using Nintendo Wii Sports.

Eligible children with cerebral palsy will be enrolled after obtaining informed consent from their legal guardians. Participants will be randomly assigned to one of two groups using a computer-based simple randomization method.

Participants in the first group will receive standard conventional physiotherapy in addition to a structured Sensory-Motor Integration-Based Exercise Program. This program is designed to target postural control, balance, body awareness, motor planning, sensory processing, and functional movement organization through tactile, vestibular, and proprioceptive sensory inputs.

Participants in the second group will receive standard conventional physiotherapy in addition to a Nintendo Wii Sports-based Virtual Reality Exercise Program. This program will provide visual and auditory feedback in a game-based environment and will aim to increase motivation, task-oriented movement repetition, balance, and functional motor performance.

The intervention period will last 16 weeks, with two sessions per week for both groups. All participants will be evaluated at baseline before the intervention and after completion of the 16-week intervention period. The primary outcome measures will include the Gross Motor Function Measure dimensions D and E, the Pediatric Balance Scale, and the Timed Up and Go Test. Secondary outcome measures will include ABILHAND-Kids, hand grip strength measured with a dynamometer, and the Physical Activity Self-Efficacy Scale for Children.

The study is expected to provide clinical evidence regarding the comparative effectiveness of sensory-motor integration-based exercises and virtual reality-based exercises as adjunctive interventions to conventional physiotherapy in children with cerebral palsy.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

8

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Elif Develi, PhD
  • Número de teléfono: +90 555 593 6293
  • Correo electrónico: elifstn@yahoo.com

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

6 años a 12 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Diagnosed with cerebral palsy, including diplegic, hemiplegic, or dyskinetic types
  • Gross Motor Function Classification System level I, II, or III
  • Aged between 6 and 12 years
  • Having sufficient cognitive ability to understand and follow simple verbal instructions
  • Voluntary participation in the study with legal guardian consent

Exclusion Criteria:

  • Gross Motor Function Classification System level IV or V
  • Spasticity level of 2 or higher in target muscle groups according to the Modified Ashworth Scale
  • Botulinum toxin injection within the last 6 months
  • Orthopedic or neurological surgery affecting motor function within the last 6 months
  • History of uncontrolled epilepsy or neurological conditions contraindicating virtual reality applications
  • Severe visual or hearing impairment that may prevent participation in the study
  • Concurrent participation in another rehabilitation program during the study period

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Sensory-Motor Integration-Based Exercise Program

Participants in this group will receive standard conventional physiotherapy in addition to a structured Sensory-Motor Integration-Based Exercise Program. The program will target postural control, balance, body awareness, motor planning, sensory processing, and functional movement organization through tactile, vestibular, and proprioceptive sensory inputs. The intervention will be delivered for 16 weeks, two sessions per week.

A structured sensory-motor integration-based exercise program targeting postural control, balance, motor planning, sensory processing, body awareness, and functional movement organization through tactile, vestibular, and proprioceptive sensory inputs. The program will be administered in addition to standard conventional physiotherapy.

Otros nombres:
  • SMIBEP
Comparador activo: Virtual Reality-Based Exercise Program

Participants in this group will receive standard conventional physiotherapy in addition to a Nintendo Wii Sports-based Virtual Reality Exercise Program. The program will provide visual and auditory feedback in a game-based environment and will aim to improve motivation, task-oriented movement repetition, balance, and functional motor performance. The intervention will be delivered for 16 weeks, two sessions per week.

A Nintendo Wii Sports-based virtual reality exercise program using visual and auditory feedback in a game-based environment to support motivation, task-oriented movement repetition, balance, and functional motor performance. The program will be administered in addition to standard conventional physiotherapy.

Otros nombres:
  • VRBEP

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Gross Motor Function Measure Dimensions D and E Score
Periodo de tiempo: Baseline and week 17

Gross motor function will be assessed using the Gross Motor Function Measure, dimensions D and E. The assessment will evaluate standing, walking, running, and jumping-related gross motor abilities in children with cerebral palsy.

Baseline and week 17
Change in Pediatric Balance Scale Score
Periodo de tiempo: Baseline and week 17

Functional balance will be assessed using the Pediatric Balance Scale. Higher scores indicate better functional balance performance.

Baseline and week 17
Change in Timed Up and Go Test Performance
Periodo de tiempo: Baseline and week 17

Functional mobility and dynamic balance will be assessed using the Timed Up and Go Test. The time required to stand up from a chair, walk 3 meters, turn, return, and sit down will be recorded in seconds. Shorter completion time indicates better functional mobility.

Baseline and week 17

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in ABILHAND-Kids Score
Periodo de tiempo: Baseline and week 17

Upper extremity and hand function in daily activities will be assessed using the ABILHAND-Kids questionnaire completed with parent or caregiver report.

Baseline and week 17
Change in Hand Grip Strength
Periodo de tiempo: Baseline and week 17

Hand grip strength will be measured using a calibrated hand dynamometer according to a standardized testing position. Measurements will be performed for each hand, and the highest value will be used for analysis.

Baseline and week 17
Change in Physical Activity Self-Efficacy Scale for Children Score
Periodo de tiempo: Baseline and week 17

Physical activity self-efficacy will be assessed using the Physical Activity Self-Efficacy Scale for Children to evaluate children's perceived confidence and ability to participate in physical activity.

Baseline and week 17

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

1 de noviembre de 2026

Finalización del estudio (Estimado)

1 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

17 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

17 de septiembre de 2026

Publicado por primera vez (Actual)

23 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data will not be shared due to the small sample size, pediatric population, and privacy considerations. De-identified aggregate results may be reported in scientific publications or presentations.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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