Metin Sabancı İlköğretim Okulu
Istanbul, Turkey (Türkiye)
NCT Number: NCT07836517
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.
Trial opening soon.
Get Notified6 year–12 year
All sexes
Interventional
Not applicable
Istanbul, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: SMIBEP
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.
Other names: VRBEP
Time frame: 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.
Time frame: Baseline and week 17
Functional balance will be assessed using the Pediatric Balance Scale. Higher scores indicate better functional balance performance.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Yeditepe University
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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