Intensive Rehabilitation Program for Upper Limb in Children and Adolescents With Cerebral Palsy

Официальное название

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

Обзор

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.

Вмешательства

• Другое Intensive Rehabilitation
  Children aged 3 to 8 years : 2 weeks program over 10 days including two individual sessions and three group sessions per participant per day combining CIMT and BIT. Adolescents aged 9 to 17 years in day-hospital care/ in inpatient care: 2 weeks program over 10 days including two individual sessions and three group sessions per participant per day combining CIMT and BIT. Daily routines, and activities involve functional and playful motor tasks of progressively increasing difficulty.

Первичные конечные точки

• Assisting Hand Assessment (AHA) /Both Hands Assessment(BoHA) [Срок оценки: 3 months]

Вторичные конечные точки (7)

• Melbourne Assessment 2 [Срок оценки: 3 months]
• Canadian Occupational Performance Measure (COPM) [Срок оценки: 3 months]
• Goal Attainment Scaling (GAS) [Срок оценки: 3 months]
• Children's Hand Experience Questionnaire (CHEQ) [Срок оценки: 3 months]
• Box and Blocks test [Срок оценки: 3 months]
• Gross Motor Function Measure (GMFM) [Срок оценки: 3 months]
• 6 minutes walking test [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Fondation Ellen Poidatz — Saint-Fargeau-Ponthierry

Идентификаторы

NCT: NCT07285837 · Habil'Hand+

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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