Association of a HABIT-ILE Course and a Home Programme on the Bimanual Performance of Children Aged 3 to 5 Years With Cerebral Palsy: a Multicentre Randomised Controlled Trial of Non-inferiority
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Assisting Hand Assessment (AHA)
研究概览
简要总结
This non-inferiority, mixed-methods, multicentre randomised controlled trial will compare the effects of functional changes and families' resources at 3 months of the PARTNER programme (35h HABIT-ILE + 15h home programme) with the reference HABIT-ILE programme (50h) on the bimanual performance (Assisting Hand Assessment [AHA]) of 66 children with unilateral CP aged 3 to 5 years.
详细描述
The PARTNERSHIP study will compare, for the first time, a mixed PARTNER camp modality, including a HABIT-ILE camp modality and a home programme modality, with parental coaching, to a reference HABIT-ILE modality.
The children in the PARTNER group will therefore spend 3.5 hours a day for 10 days in HABIT-ILE therapy, plus 1.5 hours a day for 10 days in home activities carried out by the family.
The children in the HABIT-ILE group will have 5 hours of HABIT-ILE therapy per day, the reference modality.
A non-inferiority, mixed-methods, multicentre randomised controlled trial will be conducted to compare the effectiveness of the PARTNER programme with the reference HABIT-ILE programme on the bimanual performance (Assisting Hand Assessment [AHA]) of children with unilateral CP aged 3 to 5 years. The secondary aims are to compare the 3-month effectiveness of the programmes on occupational performance, functional skills and upper limb activity levels, as well as families' resources, the parent-child relationship, the quantity and quality of resources available in the home to stimulate the child's motor development, and parental perceptions of their child's disability and their child's abilities (qualitative study). The tertiary aim is to conduct a cost-effectiveness analysis of care consumption in each group up to 6 months after the end of the programmes.
Target recruitment is 66 children (33 in each group) from 3 centres in France. Outcomes will be evaluated before the interventions, immediately after, at 3 months and up to 6 months for the cost-effectiveness analysis. Families in the PARTNER group will receive specific coaching and extensive support to perform the home programme. The coaching will focus on enhancing their resources.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child with unilateral CP confirmed by a physician
- •Child aged between 3 years and 5 years 11 months (corrected age) at study entry
- •Ability to grasp a light object and lift it ≥15cm above the table using the affected hand.
- •Ability to understand instructions and complete all assessments.
- •Matched with another child based on age (± 3 months), CP aetiology, and Manual Ability Classification System (MACS) level.
- •Written informed consent obtained from a parent or legal guardian.
- •Commitment to having the same parent or guardian participate throughout the study.
排除标准
- •Diagnosis of ataxic CP.
- •Uncontrolled epilepsy.
- •History of botulinum toxin injection or surgery within 6 months of study entry or scheduled within 3 months of the intervention (ie, during the study period).
- •Visual or auditory deficits that could interfere with participation in the study.
- •Significant cognitive or behavioural disorder limiting the ability to follow instructions, as reported in discussions with the family, therapists and/or during a prior assessment
研究组 & 干预措施
HABIT-ILE
Subjects will receive 50 hours of HABIT-ILE as camp format 5h/day, 5 days/week for two weeks.
干预措施: Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (Other)
PARTNER
Subjects will receive 35 hours of HABIT-ILE as camp format 3,5h/day, 5 days/week and 15 hours of home programme 1,5h/day, 5 day/week. These two procedures will be carried out concurrently over a 2-week period.
干预措施: Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (Other)
结局指标
主要结局
Assisting Hand Assessment (AHA)
时间窗: At the baseline (T0), at the end of the camp (T1: T0 + 21 + 2 days), and during the follow-up visit (T2: T0 + 90+2 days)
The Assisting Hand Assessment (AHA) is a valid tool to assess children's ability to perform bimanual tasks, focusing on the functional use of the impaired hand. Its validity, reliability and responsiveness have been demonstrated, and it is regularly used in studies of children with unilateral CP. The raw AHA scores (min: 22 to max: 88) will be covered to a logit scale from 0 to 100 in order to obtain an interval scale, a proprety that the raw scores do not have. The conversion to this scale is based on a Rasch model. An increase in the AHA score indicates an improvement in the child's hability to perform bimanual taks. This study falls into the "Balanced Advantages" model of non-inferiority study designs. In this model, it is common to accept an inferiority level of 10 to 50% of the experimental treatment compared with the reference treatment. For this study, we set the accepted inferiority at -10% of the known values for the reference HABIT-ILE treatment; approximately 5 points.
次要结局
- Changes of family resources: The Psychological Empowerment Scale (PES)(At the baseline (T0), at the end of the camp (T1: T0+ 21+2 days), and during the follow-up visit (T2: T0+ 90+2days))
- Canadian Measure of Occupational Performance (COPM)(At the baseline (T0), at the end of the camp (T1: T0+ 21+2 days), and during the follow-up visit (T2: T0+ 90+2 days))
- Pediatric Evaluation of Disability Inventory Computer Adaptative Test (PEDI-CAT)(At the baseline (T0), at the end of the camp (T1: T0+ 21+2 days), and during the follow-up visit (T2: T0 +90+2 days))
- Gross motor activity and upper limb activity(4 days at home before T0, during the camp, 4days at home before T2)
- Changes of family resources: World health organization quality of life - Bref (WHOQOL-Bref)(At the baseline (T0), at the end of the camp (T1: T0+ 21+2 days), and during the follow-up visit (T2: T0+ 90+2 days))
- Changes of family resources: The Enabling Practice Scale (EPS)(At the baseline (T0), at the end of the camp (T1: T0+ 21+2 days), and during the follo-up visit (T2: T0+90+2 days))
- Changes of family resources: The Parental Stress Inventory (PSI)(At the baseline (T0), at the end of the camp (T1: T0+ 21±2 days)), and during the follow-up visit (T2: T0+ 90±2 days))
- Home Environment for Motor Development Self-Report (AHEMD-SR)(At the baseline (T0), at the end of the camp (T1: T0+ 21±2 days)), and during the follow-up visit (T2: T0+ 90±2 days))
- Parent-Child Early Relational Assessment (PCERA)(At the baseline (T0), at the end of the camp (T1: T0+ 21±2 days), and during the follow-up visit (T2: T0+ 90±2 days))
- Parental representations: PARTNER programme(At the baseline (T0), and during the follow-up visit (T2: T0+ 90±2 days))
- Cost-effectiveness analysis(From baseline (T0) to the end of the camp (T1: T0+ 21±2 days)
- Impact on care consumption(From baseline (T0) to 6 months post intervention.)
- Canadian Measure of Occupational Performance (COPM)(At the baseline (T0), at the end of the camp (T1: T0+ 21+2 days), and during the follow-up visit (T2: T0+ 90+2 days))
- Changes of family resources: World health organization quality of life - Bref (WHOQOL-Bref)(At the baseline (T0), at the end of the camp (T1: T0+ 21+2 days), and during the follow-up visit (T2: T0+ 90+2 days))
- Changes of family resources: The Psychological Empowerment Scale (PES)(At the baseline (T0), at the end of the camp (T1: T0+ 21+2 days), and during the follow-up visit (T2: T0+ 90+2days))
- Pediatric Evaluation of Disability Inventory Computer Adaptative Test (PEDI-CAT)(At the baseline (T0), at the end of the camp (T1: T0+ 21+2 days), and during the follow-up visit (T2: T0 +90+2 days))
- Gross motor activity and upper limb activity(4 days at home before T0, during the camp, 4days at home before T2)
- Changes of family resources: The Enabling Practice Scale (EPS)(At the baseline (T0), at the end of the camp (T1: T0+ 21+2 days), and during the follo-up visit (T2: T0+90+2 days))
- Changes of family resources: The Parental Stress Inventory (PSI)(At the baseline (T0), at the end of the camp (T1: T0+ 21±2 days)), and during the follow-up visit (T2: T0+ 90±2 days))
- Home Environment for Motor Development Self-Report (AHEMD-SR)(At the baseline (T0), at the end of the camp (T1: T0+ 21±2 days)), and during the follow-up visit (T2: T0+ 90±2 days))
- Parent-Child Early Relational Assessment (PCERA)(At the baseline (T0), at the end of the camp (T1: T0+ 21±2 days), and during the follow-up visit (T2: T0+ 90±2 days))
- Parental representations: PARTNER programme(At the baseline (T0), and during the follow-up visit (T2: T0+ 90±2 days))
- Cost-effectiveness analysis(From baseline (T0) to the end of the camp (T1: T0+ 21±2 days)
- Impact on care consumption(From baseline (T0) to 6 months post intervention.)