Trunk Activity Rehabilitation in Young Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Peak anterior deceleration of the sternum at the start of weight-bearing
研究概览
简要总结
Children with CP exhibit trunk control issues from early childhood, affecting their balance and gait. These issues manifest as unstable walking, increased step width, and more pronounced anterior deceleration of the sternum. Previous studies have shown that early action of the triceps surae compensates for the deficit in trunk postural control. Rehabilitation targeting the trunk has shown significant improvements in postural control and gait.
The main objective is to demonstrate that RAIT (Rehabilitation by Activities Involving the Trunk) significantly reduces the peak anterior deceleration of the sternum at the beginning of the stance phase during barefoot spontaneous walking, with an enhanced effect from prolonged RAIT duration.
Secondary objectives include reducing the downward deceleration of the fifth lumbar vertebra (L5), step width, gait variability index, and improving scores on the early clinical balance scale and the global motor function evaluation.
Participants, children with spastic paraparesis or spastic hemiparesis capable of walking independently, are divided into two groups: one group continuing their usual rehabilitation for 3 months followed by RAIT for 9 months (RH-RAIT), and one group following RAIT for 12 months (RAIT-RAIT). RH involves rehabilitation exercises for lower limb muscles, while RAIT focuses on improving trunk postural control through activities involving intermediate postures.
Functional motor assessments will be conducted initially, then at 3, 6, and 12 months. These include clinical evaluations, gait analysis (step width, gait variability index, anterior foot support), and an analysis of static standing displacement using an inertial sensor placed at L5.
At M0, children with CP are expected to show higher values for deceleration peaks and gait variability indices, and lower scores on evaluation scales compared to typically developing (TD) children. After RAIT, an improvement in judgment criteria is expected: reduction in deceleration peaks, cycle width, gait variability index, anterior foot support, and an increase in scores on the ECPE and EMFG-66-SI.
This study aims to confirm that rehabilitation through trunk-involving activities is more effective than usual rehabilitation in improving postural control and gait dynamics in young children with cerebral palsy, suggesting that this approach could become a standard rehabilitation practice from early childhood.
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
入排标准
- 年龄范围
- 18 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For children with CP
- •Age between 18 months and 5 years 6 months
- •CP type: spastic paraparesis or spastic hemiparesis, GMFCS I to II
- •No or moderate retraction of the sural triceps (ankle dorsiflexion: > 5° on clinical examination, knee straight)
- •Sufficient level of understanding to carry out activities involving the trunk in the form of self-exercises (rehabilitation protocol), as well as clinical assessments and functional explorations.
- •Acceptance by the physiotherapist in charge of the child's follow-up to collaborate in carrying out the RAIT.
- •Affiliated with a social security scheme
- •For children with DT
- •Age between 18 months and 5 years 6 months
- •Walking acquired before age 18 months
- •Sufficient level of understanding to perform clinical assessments and functional explorations
- •Affiliated with a social security scheme
排除标准
- •For children with CP
- •Previous surgery on lower limbs less than 1 year ago
- •Botulinum toxin A injection less than 6 months ago
- •Any change in rehabilitative and/or orthopedic management in the last 2 months
- •Hip flessum > 20
- •Presence of subacute or chronic pain on standing or walking
- •For children with DT
- •- Neurological and/or orthopedic disorders that may influence gait
结局指标
主要结局
Peak anterior deceleration of the sternum at the start of weight-bearing
时间窗: At inclusion, then 3, 6 and 12 months later
Varaible obtained via the analysis of walking on a zeno treadmill. A reduced value is expected after RAIT rehabilitation.
次要结局
- Gait variability index(At inclusion, then 3, 6 and 12 months later)
- Cycle width(At inclusion, then 3, 6 and 12 months later)
- peak downward deceleration of L5 at the start of support(At inclusion, then 3, 6 and 12 months later)
- The Early Clinical Balance Scale(At inclusion, then 3, 6 and 12 months later)
- Global Motor Function Classification System family report questionnaire(At inclusion)
- EMFG-66-SI(At inclusion, then 3, 6 and 12 months later)
- "Reach out" questionnaire(At inclusion, then 3, 6 and 12 months later)
- Anterior support of the foot during 1st double support(At inclusion, then 3, 6 and 12 months later)
- Edinburgh walk visual score(At inclusion, then 3, 6 and 12 months later)
- Neuro-orthopaedic assessment(At inclusion, then 3, 6 and 12 months later)