Functional and Neuroplastic Effects of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Children With Bilateral Cerebral Palsy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Changes in Gross Motor Function
研究概览
简要总结
This randomized controlled trial will compare the effects of neuroplastic and functional changes of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) when presented in two periods (2HG; n=24) versus a single period (1HG; n=24) in people with bilateral CP. The 1HG will receive 65 hours of HABIT-ILE over one intervention period; the 2HG will receive 130 hours over two intervention periods, within 6 months apart. Children will be assessed at 6 time points: baseline, three weeks after the start, at 3, 6, 7 and 9 months after the start of the study.
详细描述
This study aims to compare, for the first time, the effects of a double period of HABIT-ILE therapy on functional and neuroplastic changes against a single period, in people with bilateral cerebral palsy (CP). Previous HABIT-ILE protocols have only assessed the effects of a single intervention period. Still, the literature suggests a possible dose-response relationship between the number of intensive therapy periods and progress in motor function.
A randomized controlled trial will be conducted, comparing the effects of a double period of HABIT-ILE; (2HG; n=24) versus a single period (1HG; n=24) in children and youth with bilateral CP. Each HABIT-ILE period will consider 6.5 hours of intervention during 10 consecutive working days. Children will be assessed at 6-time points: baseline, three weeks after, at 3 months, at 6 months, at 7 months, and at 9 months, to evaluate the long-term effect of HABIT-ILE and the summative effects of the double period in functional and neuroplastic variables. The 1HG will receive only 65 hours of HABIT-ILE after baseline; the 2HG will perform 130 hours over two intervention periods, after baseline and again at 6 months.
Overall, this study aims to provide evidence for the effectiveness of HABIT-ILE in producing functional and neuroplastic changes in children with bilateral CP. It will allow us to approach the possible mechanisms underlying the effect of HABIT-ILE.
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 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with medical diagnosis of bilateral cerebral palsy
- •Cognitive capacity and language that allows understanding and following the therapist's instructions.
- •Manual Ability Classification System (MACS) levels I to III
- •Bimanual Fine Motor Function (BFMF) levels I to III
- •Gross Motor Function Classification System (GMFCS) levels I to III
排除标准
- •Severe visual problems
- •Movement restriction due to orthopedic surgery in less than a year
- •Treatment with botulinum toxin and/or baclofen pump in the last 6 months
- •Contraindications to receive transcranial magnetic stimulation (epileptic history, metallic implants, neoplasm, etc.)
结局指标
主要结局
Changes in Gross Motor Function
时间窗: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)
The Gross Motor Function Measure is a standardized observational instrument designed to measure changes in gross motor function over time or following an intervention in children and youth with cerebral palsy using Rasch analysis. It is scored on a scale of 0 to 3, where 0 means the person cannot perform the activity and 3 means the person can complete the item. The score is converted to a percentage. A higher percentage means a better gross motor function.
次要结局
- Selective Control Assessment of the Lower Extremity (SCALE)(Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5))
- ABILHAND-Kids questionnaire(Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5))
- Changes of oxyhemoglobin concentration in sensorimotor cortex(Time Frame: Baseline (T0), two weeks after start (T1), at 6 months (T3), and at 7 months (T4))
- Melbourne 2 Assessment (MA2)(Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)])
- Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)(Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5))
- Participation and Environment Measure - Children and Youth (PEM-CY)(Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5))
- Canadian Occupational Performance Measure (COPM)(Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5))
- Both Hands Assessment (BoHA)(Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)])
- Six minutes walk test (6MWT)(Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5))
- Attention network test (ANT)(Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5))
- Test of Arm Selective Control (TASC)(Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5))
- ACTIVLIM-CP questionnaire(Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5))
- Behaviour Rating Inventory of Executive Function (BRIEF-2)(Time Frame: Baseline (T0), at 3 months (T2), at 6 months (T3), and at 9 months (T5))
- Changes of peak-to-peak amplitude of motor evoked potential(Time Frame: Baseline (T0), two weeks after start (T1), at 6 months (T3), and at 7 months (T4))
- Changes of latency in motor evoked potential(Time Frame: Baseline (T0), two weeks after start (T1), at 6 months (T3), and at 7 months (T4))
- Changes of Resting Motor Threshold(Time Frame: Baseline (T0), two weeks after start (T1), at 6 months (T3), and at 7 months (T4))
- Changes of oxyhemoglobin concentration in prefrontal cortex(Time Frame: Baseline (T0), two weeks after start (T1), at 6 months (T3), and at 7 months (T4))
研究者
Rodrigo Araneda, PhD
Principal Investigator
Universidad Nacional Andres Bello