Clinical trial NCT04899284: Impact of Early Intensive Stimulation on Bimanual Function in Infants at High Risk of Unilateral CP (BB-BIM)
Official title: Impact of Early and Intensive Bimanual Stimulation on the Evolution of Bimanual Function in Infants With Clinical Findings Suggesting Unilateral Cerebral Palsy (BB-BIM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Unilateral cerebral palsy
Unilateral brain lesion
Infantile cerebral palsy
Lead sponsor: Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
Sponsor class: OTHER
Collaborators: name: Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL) - France
name: Hospices Civils de Lyon
name: Laboratoire de Biomécanique et Mécanique des Chocs (LBMC) - France
First posted: 2021-05-24
Enrollment: 5
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hand Assessment in Infants (HAI)
timeFrame: Change from baseline at 2 months with a weekly evaluation
Secondary outcomes:
measure: Actimetry
timeFrame: Change from baseline at 2 months with a weekly evaluation
measure: Goal Attainment Scales
timeFrame: Change from baseline at 2 months with a weekly evaluation
measure: Compliance
timeFrame: Change from baseline at 2 months with a weekly evaluation
measure: Parent satisfaction questionnaire
timeFrame: 2 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues
Study officials:
affiliation: Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues. Lyon, France
name: Rachel Bard-Pondarré, OT
role: PRINCIPAL_INVESTIGATOR
affiliation: Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues. Lyon, France
name: Emmanuelle Chaléat-Valayer, PhD
role: STUDY_DIRECTOR
affiliation: Hopital Femme Mère Enfant, l'Escale MPR pédiatrique (Hospices Civils de Lyon). Bron, France
name: Carole Vuillerot, PhD
role: STUDY_DIRECTOR
References: