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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in Gross Motor Function Measure Dimensions D and E Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking will be applied because participants and care providers cannot be blinded to the type of exercise-based intervention.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Sensory-Motor Integration-Based Exercise Program (Behavioral)
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.
干预措施: Virtual Reality-Based Exercise Program (Behavioral)
结局指标
主要结局
Change in Gross Motor Function Measure Dimensions D and E Score
时间窗: 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.
Change in Pediatric Balance Scale Score
时间窗: Baseline and week 17
Functional balance will be assessed using the Pediatric Balance Scale. Higher scores indicate better functional balance performance.
Change in Timed Up and Go Test Performance
时间窗: 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.
次要结局
- Change in ABILHAND-Kids Score(Baseline and week 17)
- Change in Hand Grip Strength(Baseline and week 17)
- Change in Physical Activity Self-Efficacy Scale for Children Score(Baseline and week 17)