Effect of an Intensive Rehabilitation Protocol Combining Constraint-Induced Movement Therapy and Bimanual Training on Upper Limb Use and Gross Motor Function in Children and Adolescents With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Assisting Hand Assessment (AHA) /Both Hands Assessment(BoHA)
研究概览
简要总结
Cerebral palsy is the most common motor disability in children. Individuals with CP often experience significant difficulties in the use of their upper limbs, which affects their autonomy and quality of life. Conventional rehabilitation, although essential, is often insufficient to compensate for these deficits in a meaningful way.
The French National Authority for Health has issued recommendations for intensifying rehabilitation in order to maximize functional gains in children with CP. Among the intensive approaches that have been studied, two techniques have demonstrated efficacy: Constraint-Induced Movement Therapy (CIMT) and Bimanual Intensive Therapy (BIT).
CIMT focuses on restricting the use of the unaffected limb to encourage the use of the affected limb, thereby promoting neuroplasticity and functional improvement. In contrast, BIT emphasizes intensive training of both hands simultaneously to enhance coordination and overall upper limb functionality.
At the Ellen Poidatz Foundation, an intensive rehabilitation program has been developed that combines these two complementary approaches. This program, which is already in place, is based on the principles of neuromotor rehabilitation and motor learning. It integrates several methods recommended by the HAS, including Bimanual Intensive Therapy (BIT) such as HABIT (Grade A) or HABIT-ILE (Grade B), Modified Constraint-Induced Movement Therapy (mCIMT) (Grade B), and Adapted Physical Activity (APA) (Grade A).
The aim of this intensive program is to enhance the functional use of the upper limb by improving bimanual coordination, grasping, manipulation, and overall motor function. The program lasts 10 days over a 2-week period and is tailored to the child's age and care setting. It includes approximately 60 hours of rehabilitation for children aged 3 to 8 years and 80 hours for those aged 9 to 17 years, in line with current international recommendations.
The aim of this study is to evaluate the effectiveness of this existing intensive rehabilitation program in improving manual abilities in children with CP. Specifically, the study seeks to objectively assess the benefits of the Habil'Hand+ program and to contribute to the optimization of rehabilitation protocols for this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of CP mentioned in the medical record
- •Aged between 3 and 17 years inclusive (<18 years)
- •Global Motor Function Classification System (GMFCS) and Manual Ability Classification System (MACS) levels I to IV
- •Ability to cooperate, understand and follow simple instructions
- •Patient affiliated to the French social security system
- •Voluntary patient whose parents have given their consent for their child to participate in the study.
排除标准
- •Presence of injuries incompatible with participation in the program, or pain rated >3 on the Visual Analogue Scale (VAS)
- •Presence of behavioral disorders
- •History of botulinum toxin injections or surgical intervention within six months prior to study enrollment.
研究组 & 干预措施
CP children and adolescents
The program is tailored to the child's age and care setting. Children aged 3 to 8 years : 2 weeks program over 10 days with a total of 60 hours of CIMT+ BIT in a day-hospital setting.
Adolescents aged 9 to 17 years in day-hospital care : 2 weeks program over 10 days with a total of 80 hours of CIMT+ BIT in a day-hospital setting.
Adolescents aged 9 to 17 years in inpatient care : 2 weeks program over 10 days with a total of 80 hours of CIMT+ BIT in inpatient care.
干预措施: Intensive Rehabilitation (Other)
结局指标
主要结局
Assisting Hand Assessment (AHA) /Both Hands Assessment(BoHA)
时间窗: 3 months
The AHA determine a score of natural use of the affected upper limb in standardized activity test. The BoHA is a standardized test designed for children with bilateral cerebral palsy. Both assessments contains 20 items rated on a 4-point scale (4=effective, 3=somewhat effective, 2=ineffective, and 1=does not do). A higher score therefore represents better performance.
次要结局
- Melbourne Assessment 2(3 months)
- Canadian Occupational Performance Measure (COPM)(3 months)
- Goal Attainment Scaling (GAS)(3 months)
- Children's Hand Experience Questionnaire (CHEQ)(3 months)
- Box and Blocks test(3 months)
- Gross Motor Function Measure (GMFM)(3 months)
- 6 minutes walking test(3 months)