Effect of Hand and Arm Bimanual Intensive Therapy Including Lower Extremities on the Body Function and Structures of Children With Bilateral and Unilateral Cerebral Palsy, Including Selective Voluntary Motor Control and Brain Structure
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in Test of Arm Selective Control (TASC)
研究概览
简要总结
There is strong evidence that recent intensive interventions based on motor skill learning principles are efficient on functional and neuroplastic changes of children with cerebral palsy (CP).
Besides, impaired selective voluntary motor control (SVMC) is one of four interrelated neuromuscular deficits in children with CP and is listed in the ICF-CY (International Classification of Functioning, Disability and Health for Children and Youth) under body functions. Additionally, impaired SVMC has been shown to negatively affect the motor and functional abilities of children with CP. However, there have been little scientific investigations on the trainability of SVMC according to therapeutic interventions.
Therefore, the study aims to evaluate the effect of Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) on the body function and structures of children with bilateral and unilateral cerebral palsy, including SVMC and brain structure.
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
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed bilateral and unilateral cerebral palsy,
- •MACS levels from I to IV,
- •GMFCS levels from I to IV,
- •Ability to follow instructions and complete testing.
排除标准
- •Orthopedic surgery, botulinum toxin injections or another unusual intervention less than 6 months before or within the study period.
- •Unstable seizure
- •Severe visual or cognitive impairments likely to interfere with intervention or testing session completion
结局指标
主要结局
Changes in Test of Arm Selective Control (TASC)
时间窗: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
The TASC is an upper limb selective motor control evaluation tool including eight motions in each arm and up to three attempts are allowed for each motion. This assessment tool was developed in 2010 and Sukal-Moulton et al. have proved its validity and reliability for children with CP in 2017. After completion of the best attempt, points ranging from 0 (absent), 1 (impaired) to 2 (normal) are recorded for each joint depending on the movement properties and descriptors of the test.
Changes in Stiffness
时间窗: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
The stiffness will be measured using a device developed and already validated at UCLouvain.
Changes in Diffusion Tensor Imaging (DTI)
时间窗: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
This sequence allows to measure changes in the fractional anisotropy (FA) on the white matter tracts. FA is a scalar value (no unit) between zero and one that describes the degree of anisotropy of white matter water molecules.
Changes in Strength
时间窗: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
The strength will be measured for main muscle groups using a Microfet.
Changes in Selective Control Assessment of the Lower Extremity (SCALE):
时间窗: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
The SCALE was designed to evaluate lower limb selective motor control of children with cerebral palsy. The SCALE includes testing of five reciprocal lower extremity movements. SVMC is graded at each joint as 'Normal' (2 points), 'Impaired' (1 point), or 'Unable' (0 points).
次要结局
- Changes in ABILHAND-Kids Questionnaire(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Changes in 6 Minutes Walking Test (6MWT)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Changes in Box and Blocks test(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Changes in Jebsen-Taylor Test(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Changes in temporal parameters of the gait (Cycle time)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Changes in temporal parameters of the gait (Stance time)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Changes in temporal parameters of the gait (Velocity)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Changes in Modified Cooper test(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Changes in ABILOCO-Kids Questionnaire(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Changes in Double Inversion Recovery (DIR)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Changes in Assisting Hand Assessment (AHA or BoHA)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Changes in ACTIVLIM-CP Questionnaire(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Changes in Gross Motor Function Measurement (GMFM 66)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Changes in Executive Functions(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Changes in temporal parameters of the upper extremity (Kinematics assessments)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Changes in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Changes in Canadian Occupational Performance Measure (COPM)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Changes in Functional resting state (RS)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Changes in T1-weighted and T2-weighted structural imaging(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Changes in temporal parameters of the gait (Swing time)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Changes in spatial parameters of the upper extremity (Straightness)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Changes in spatial parameters of the upper extremity (Smoothness)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Changes in spatial parameters of the gait (Kinematics assessments)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Changes in temporal parameters of the gait (Stride)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Changes in temporal parameters of the gait (Acceleration)(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
研究者
Yannick Bleyenheuft
Professor
Université Catholique de Louvain