Effects of HABIT-ILE in Secondary Brain Damage Outcomes of Infants and Toddlers With Signs of Cerebral Palsy
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Changes on the Mini-Assisting Hand Assessment (Mini-AHA)
研究概览
简要总结
Using a randomized controlled trial design, the possible changes induced by the intensive treatment programme "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" in functional, everyday life activities and neuroplastic assessment will be studied in infants and toddlers with cerebral palsy.
详细描述
Using a randomized controlled trial design, the possible changes in neuroimaging, motor function and everyday life activities of infants and toddlers at risk of or with a diagnosis of cerebral palsy after participating of the intensive treatment programme "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" will be studied . Changes, scored by parents in case of questionnaires and by experts in the case of tests, will be observed comparing infants/toddlers after their regular care and after receiving HABIT-ILE. Motor function and daily life activities will be correlated with neuroplastic changes. Moreover, possible therapy onset outcomes differences will be observed.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children with diagnosed unilateral cerebral palsy or at risk of developing unilateral cerebral palsy or with signs of unilateral cerebral palsy
- •age 8 to 18 months inclusive (corrected age if preterm birth)
- •ability to follow instructions and complete testing according to the age.
排除标准
- •active seizure
- •programmed botulinum toxin or orthopedic surgery in the 6 months previous to the intervention, during intervention period or 6 months after the intervention time.
- •severe visual impairments
- •severe cognitive impairments
- •contraindications to perform magnetic image resonance (MRI) assessments (metal implants, etc.)
结局指标
主要结局
Changes on the Mini-Assisting Hand Assessment (Mini-AHA)
时间窗: baseline, 3 weeks, 13 weeks and 26 weeks after baseline
Measures how well infants (8-18 months) with signs of unilateral or hemiplegic cerebral palsy use their more affected hand, when using both hands together to play (scored in percentage).
次要结局
- Changes in Bayley Scales of Infant and Toddler Development - Third Edition (BSID-III)(baseline, 3 weeks, 13 weeks and 26 weeks after baseline)
- Changes in Visuo-spatial attention assessment with the "Batterie d'évaluation du Jeune Enfant" (BAJE)(baseline, 3 weeks, 13 weeks and 26 weeks after baseline)
- Changes in Gross Motor Function Measure - 66 (GMFM-66)(baseline, 3 weeks, 13 weeks and 26 weeks after baseline)
- Changes in Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT)(baseline, 3 weeks, 13 weeks and 26 weeks after baseline)
- Changes in smoothness on kinematics of the upper extremity(baseline, 3 weeks, 13 weeks and 26 weeks after baseline)
- State of visual impairment of peripheral origin assessed with the standard Battery of Ophthalmological test for infants(baseline)
- Changes in Canadian Occupational Performance Measure (COPM)(baseline, 3 weeks, 13 weeks and 26 weeks after baseline)
- Changes in straightness on kinematics of the upper extremity(baseline, 3 weeks, 13 weeks and 26 weeks after baseline)
- Changes in Fractional Anisotropy (FA) of the corticospinal tract from the motor cortex to the cerebellar peduncle(baseline, 3 weeks, 13 weeks and 26 weeks after baseline)
- Changes on the metrics of the corticospinal tract from the motor cortex to the cerebellar peduncle using the NODDI model(baseline, 3 weeks, 13 weeks and 26 weeks after baseline)
- Changes in Young children's participation and environment measure (YC-PEM)(baseline, 3 weeks, 13 weeks and 26 weeks after baseline)
- Changes on the Axial, Radial and Mean Diffusivity (AD, RD, MD) of the corticospinal tract from the motor cortex to the cerebellar peduncle(baseline, 3 weeks, 13 weeks and 26 weeks after baseline)
- Changes in brain white matter microstructure (WM-μs) using the Microstructure Fingerprinting model(baseline, 3 weeks, 13 weeks and 26 weeks after baseline)
- Changes in time of activity on kinematics of the upper extremity(baseline, 3 weeks, 13 weeks and 26 weeks after baseline)
- Changes in the quantification of physical activity(baseline, 3 weeks, 13 weeks and 26 weeks after baseline)
- Changes in cortical thickness of the brain's gray matter(baseline, 3 weeks, 13 weeks and 26 weeks after baseline)
- Changes of the fraction and heterogeneity in the neural fibers or isotropic compartments of the corticospinal tract from the motor cortex to the cerebellar peduncle using the DIAMOND model(baseline, 3 weeks, 13 weeks and 26 weeks after baseline)
- Changes in resting-state functional connectivity(baseline, 3 weeks, 13 weeks and 26 weeks after baseline)