Dynamic Surface Exercise Training and Static Surface Exercise Training in Cerebral Palsy Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Gross Motor Function Measure-66 (GMFM-66) Score
研究概览
简要总结
This randomized clinical trial aims to compare the effects of Dynamic Surface Exercise Training (DSET) and Static Surface Exercise Training (SSET) on balance and gross motor function in children with spastic diplegic cerebral palsy (CP) aged 6-12 years, classified at Gross Motor Function Classification System (GMFCS) levels III-IV. CP is the most common motor disability of childhood, characterized by non-progressive disturbances to the developing brain, leading to impairments in movement, posture, and functional independence. Balance deficits and gross motor limitations significantly impact daily activities and quality of life in these children.
Dynamic surfaces such as Swiss balls, bolsters, and platform swings provide postural perturbations that challenge vestibular, proprioceptive, and visual systems, potentially enhancing trunk control, postural stability, and adaptive responses. In contrast, static surface exercises emphasize controlled strength, postural alignment, and functional task performance on stable platforms such as mats or benches.
Fifty participants meeting the inclusion criteria will be randomly allocated into two equal groups. The DSET group will receive 60-minute sessions, four days per week for six weeks, involving multi-planar trunk activation, optimal arousal activities, and dynamic balance tasks on unstable surfaces. The SSET group will perform equivalent-duration exercises on stable surfaces, focusing on functional reaching, transfers, and static/dynamic balance.
Primary outcomes are Gross Motor Function Measure-66 (GMFM-66) and Pediatric Balance Scale (PBS), assessed at baseline, week 3, and week 6 by a blinded evaluator. Statistical analyses will compare within- and between-group changes. Findings will help identify the more effective approach for improving functional outcomes in children with CP, guiding evidence-based pediatric neurorehabilitation strategies.
详细描述
Cerebral palsy (CP) encompasses a group of permanent disorders affecting movement and posture due to non-progressive disturbances in the developing fetal or infant brain. Spastic diplegic CP often results in muscle tone abnormalities, postural instability, and reduced gross motor function. These impairments hinder participation in daily activities and increase fall risk. Motor deficits are closely linked to postural control, which depends on integrated sensory input from visual, vestibular, and somatosensory systems.
Dynamic surface training introduces controlled instability through tools like Swiss balls, bolsters, trampolines, and platform swings. This variability promotes adaptive postural adjustments and multi-planar muscle activation, potentially enhancing gross motor skills and balance beyond what is achieved with stable surfaces. Static surface training, using mats, benches, or floors, emphasizes strength, posture, and functional movement without additional instability challenges.
This single-center, single-blinded, randomized clinical trial will recruit 50 children aged 6-12 years with spastic diplegic CP (GMFCS III-IV) who can follow verbal commands and meet other inclusion criteria. Participants will be randomly allocated to:
Group A (DSET): 6-week program, 60 min/day, 4 days/week. Activities include optimal arousal (active/passive bouncing), high sitting with one-hand/both-hands reaching, sit-to-stand transitions, multi-directional reaching, trunk activation, and dynamic balance exercises on unstable surfaces.
Group B (SSET): 6-week program, 60 min/day, 4 days/week. Exercises include transfers between sitting and quadruped, high sitting on a bench with functional reaching, static/dynamic standing balance, and trunk activation tasks on stable surfaces.
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
- Single (Outcomes Assessor)
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
- •Children diagnosed with spastic diplegic CP between age 6-12 years (Reddy & Balaji, 2020).
- •Both male and female gender (Reddy & Balaji, 2020).
- •Who were able to follow verbal commands.
- •Children having level III and IV of Gross Motor Function Classification System (GMFCS) (Reddy & Balaji, 2020).
排除标准
- •CP Child who were reluctant to cooperate.
- •CP child having visual or intellectual impairments (Reddy & Balaji, 2020).
- •Who were on Antiepileptic medications (Reddy & Balaji, 2020).
- •CP child having any cardiac or chest anomalies and hearing deficits.
- •Exercise intolerance and any recent orthopedic surgery will also be excluded from the study.
结局指标
主要结局
Gross Motor Function Measure-66 (GMFM-66) Score
时间窗: Baseline, Week 3, Week 6
The GMFM-66 is a standardized observational instrument used to assess gross motor function in children with cerebral palsy. It evaluates the child's ability to perform various motor tasks across lying, sitting, crawling, standing, and walking dimensions. Scores range from 0 to 100, with higher scores indicating better motor performance. Assessments will be conducted by a blinded evaluator at baseline, week 3, and week 6 to determine within- and between-group changes following Dynamic Surface Exercise Training or Static Surface Exercise Training.
Pediatric Balance Scale (PBS) Score
时间窗: Baseline, Week 3, Week 6
The PBS is a 14-item scale adapted from the Berg Balance Scale to assess static, dynamic, and functional balance in children aged 3-13 years. Each item is scored from 0 to 4, with total scores ranging from 0 to 56. Higher scores reflect better balance and postural control. A blinded evaluator will assess participants at baseline, week 3, and week 6 to measure improvement in balance performance after the assigned intervention.
Gross Motor Function Measure-66 (GMFM-66) Score
时间窗: Baseline, Week 3, Week 6
The GMFM-66 is a standardized observational instrument used to assess gross motor function in children with cerebral palsy. It evaluates the child's ability to perform various motor tasks across lying, sitting, crawling, standing, and walking dimensions. Scores range from 0 to 100, with higher scores indicating better motor performance. Assessments will be conducted by a blinded evaluator at baseline, week 3, and week 6 to determine within- and between-group changes following Dynamic Surface Exercise Training or Static Surface Exercise Training.
Pediatric Balance Scale (PBS) Score
时间窗: Baseline, Week 3, Week 6
The PBS is a 14-item scale adapted from the Berg Balance Scale to assess static, dynamic, and functional balance in children aged 3-13 years. Each item is scored from 0 to 4, with total scores ranging from 0 to 56. Higher scores reflect better balance and postural control. A blinded evaluator will assess participants at baseline, week 3, and week 6 to measure improvement in balance performance after the assigned intervention.
次要结局
未报告次要终点
研究者
Iqra Rashid
Student
University of Lahore