Implementation of a HABIT-ILE Intervention at William Lennox Neurological : a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Flanker task
研究概览
简要总结
Using a randomized controlled trial design, in an hospital environment, possible changes induced by the "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" treatment program will be investigated in functional activities of daily living, motor and cognitive assessment of children with acquired brain injury.
详细描述
The aim is to investigate, for the first time, the effectiveness of HABIT-ILE therapy in a hospital setting in the treatment of a population representative of the clinical population with children with acquired brain injuries.
The hypothesis is that an in-hospital HABIT-ILE protocol will be more effective than conventional therapies usually given to children with acquired brain injury, and that this difference will be objectively demonstrated by clinical assessments of motor function, cognition and participation conducted before and after treatment periods.
The aim of the study is therefore to evaluate the effect of intensive bimanual hand-arm therapy including the lower extremities (HABIT-ILE) on body functions and structures, activity and participation in children with acquired brain injury.
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
- •children with acquired brain injury of school
- •age 5 to 18 years inclusive
排除标准
- •Unstable seizure
- •programmed botulinum toxin or orthopedic surgery in the 6 months previous to the intervention, during intervention period or 3months after the intervention time
- •Severe visual or cognitive impairments likely to interfere with intervention or testing session completion
结局指标
主要结局
Flanker task
时间窗: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Cognitive functions of the children will be assessed by Flanker task.
Changes in Gross Motor Function Measurement (GMFM 66)
时间窗: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
The GMFM has been developed to measure the change in gross motor function over time in children with cerebral palsy.
次要结局
- Changes in isometric muscular strength (Jamar)(T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up))
- Stroop task(T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up))
- Changes in unimanual dexterity: Box and Blocks test (BBT)(T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up))
- Changes on bimanual function (Assisting Hand Assessment (AHA))(T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up))
- Changes in 6 Minutes Walking Test (6MWT)(T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up))
- Changes in Pediatric balance scale (PBS)(T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up))
- Changes in Canadian Occupational Performance Measure (COPM)(T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up))
- Changes in ACTIVLIM-CP questionnaire(T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up))
- Changes in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)(T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up))
- Changes in Pediatric quality of life inventory (PedsQL)(T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up))
- Changes in Measure of Processes of Care (MPOC-20)(T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up))
- Status in Wechsler Intelligence Scale for Children-Non verbal short version (WISC)(T0 (baseline))
- Classification du niveau moteur: The Gross Motor Function Classification System - Expanded & Revised (GMFCS - E&R)(T0 (baseline))
- QUALITY OF LIFE : KIDSCREEN 10(T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up))
研究者
Yannick Bleyenheuft
Professor
Université Catholique de Louvain