Impact of Early and Intensive Bimanual Stimulation on the Evolution of Bimanual Function in Infants With Clinical Findings Suggesting Unilateral Cerebral Palsy (BB-BIM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Hand Assessment in Infants (HAI)
研究概览
简要总结
The aim of this study is to measure the impact of early bimanual stimulation in babies with clinical signs of underuse of one hand. The observation focuses on the developmental curve of hands use. The intervention is provided by the family environment and takes place in the child's familiar surroundings.
详细描述
Congenital hemiplegia, often referred to as Unilateral Cerebral Palsy (UCP), is characterized by a unilateral or asymmetrical brain injury that occurs around birth and impacts the development of manual skills and motor abilities of one side of the body.
Affected children frequently develop hemiplegia with major limitations in the use of their impaired hand, resulting in poor bimanual coordination, thus impacting the performance of daily activities at home, school and in the community.
Several intensive therapy approaches currently exist, including the bimanual approach (BIM) which aims to improve the use of the affected hand as an assisting hand in daily functional activities. These approaches have long been established as effective, however, with these children reaching 90% of their potential gross motor skills around the age of 5, or even earlier in some cases, there is a growing interest in earlier approaches, well before school age. It has also long been established that during the first year of life, there is a critical time frame for hand motor development.
The investigators have thus set up an intensive bimanual stimulation program for infants showing early signs of UCP, delivered by the family environment, in the child's familiar surroundings, under the guidance of a therapist, over a period of 2 months.
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 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Baby between 3 and 12 months of age at the time of inclusion
- •Clinical signs of underuse of one of the two upper limbs, (reported by the parents and authenticated by the HAI)
- •Unilateral brain injury
- •Brain imaging performed at birth or upon initial parental concerns
- •Possibility of a home visit by the occupational therapist
- •At least one parent volunteering to actively participate in the intensive stimulation
- •Parental consent to enter the study
- •Consent for image rights
排除标准
- •Prematurity
- •Lack of interest suggesting underlying associated disorders
- •Active epilepsy
结局指标
主要结局
Hand Assessment in Infants (HAI)
时间窗: Change from baseline at 2 months with a weekly evaluation
The HAI was developed for infants 3 to 12 months of age; the test is performed by filming the baby during a 10-minute play session. The examiner stimulates the baby with specific toys to induce hand actions, separately and together. Scoring includes 12 unimanual and five bimanual items, each scored on a 3-modality response scale (0, 1 or 2 points). The HAI provides a score for each of the upper limbs (out of 24 points), allowing quantification of possible asymmetry in the form of an index, as well as an interval measure of hand use (the total raw score out of 58 is converted to a scale from 0 to 100 points).
次要结局
- Actimetry(Change from baseline at 2 months with a weekly evaluation)
- Goal Attainment Scales(Change from baseline at 2 months with a weekly evaluation)
- Compliance(Change from baseline at 2 months with a weekly evaluation)
- Parent satisfaction questionnaire(2 months)