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

Impact of Early and Intensive Bimanual Stimulation on the Evolution of Bimanual Function in Infants With Clinical Findings Suggesting Unilateral Cerebral Palsy (BB-BIM)

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Early Intensive Bimanual Stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69005
    • Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 1 year (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Infants eligible for Early Intensive Bimanual Stimulation; 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	Other: Early Intensive Bimanual Stimulation; Early 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand Assessment in Infants (HAI)	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).	Change from baseline at 2 months with a weekly evaluation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Actimetry	The children will wear two accelerometers (one on each wrist) several times a week, during specific time sessions (training-game time guided by the parents and free play time). The data will be recorded on three axes (vertical, anteroposterior and mediolateral) and will be converted into activity quantity, with calculations such as the amplitude of the average vector, and the ratio of use between the two upper limbs.	Change from baseline at 2 months with a weekly evaluation
Goal Attainment Scales	A maximum of 2 objectives will be determined with the parents: they will have to involve the use of the upper limb in practical situations of daily life, where a clear asymmetry of use has been observed, in order to be able to assess the evolution. The methodology used will be GAS 3 markers, the final score will be expressed on a 5-level ordinal scale, between (-2) and (+2), where (-2) corresponds to the initial level, (-1) to progress without having reached the expected level, (0) to reaching the expected level, (+1) to progress beyond the expected level, and (-2) to the most favourable result for the given objective.	Change from baseline at 2 months with a weekly evaluation
Compliance	Interview reporting the number of bimanual stimulation sessions actually completed during the past week (from T6 to T13 during the intervention phase).	Change from baseline at 2 months with a weekly evaluation
Parent satisfaction questionnaire	Assessment of satisfaction with the support provided by the occupational therapist, self-satisfaction with the role assigned to them, and satisfaction with the effectiveness of the program. List of questions to be answered with visual analog scales ranging from 0 to 10.	2 months

Collaborators and Investigators

• Sponsor: Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
• Collaborators: Hospices Civils de Lyon; Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL) - France; Laboratoire de Biomécanique et Mécanique des Chocs (LBMC) - France
• Investigators: Principal Investigator: Rachel Bard-Pondarré, OT, Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues. Lyon, France; Study Director: Emmanuelle Chaléat-Valayer, PhD, Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues. Lyon, France; Study Director: Carole Vuillerot, PhD, Hopital Femme Mère Enfant, l'Escale MPR pédiatrique (Hospices Civils de Lyon). Bron, France

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2021
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Unilateral cerebral palsy; Unilateral brain lesion; Infantile cerebral palsy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: BB-BIM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No