Impact of Early Intensive Stimulation on Bimanual Function in Infants at High Risk of Unilateral CP (BB-BIM)

Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française

Status: Completed

Conditions: Cerebral Palsy

Treatments: Other: Early Intensive Bimanual Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04899284

BB-BIM

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 5 patients

Sex: All

Ages: 3 to 12 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Prematurity
• Lack of interest suggesting underlying associated disorders
• Active epilepsy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Infants eligible for Early Intensive Bimanual Stimulation

Experimental group

Description:

Infants between 3 and 12 months of age at the time of inclusion, with unilateral brain injury and clinical signs of underuse of one of the two upper limbs

Treatment:

Other: Early Intensive Bimanual Stimulation