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

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Early Intensive Bimanual Stimulation
Sponsored by
Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Unilateral cerebral palsy, Unilateral brain lesion, Infantile cerebral palsy

Eligibility Criteria

3 Months - 12 Months (Child)All SexesDoes not accept 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

Sites / Locations

  • Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Infants eligible for Early Intensive Bimanual Stimulation

Arm 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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
Compliance
Interview reporting the number of bimanual stimulation sessions actually completed during the past week (from T6 to T13 during the intervention phase).
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.

Full Information

First Posted
May 18, 2021
Last Updated
May 25, 2023
Sponsor
Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
Collaborators
Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL) - France, Hospices Civils de Lyon, Laboratoire de Biomécanique et Mécanique des Chocs (LBMC) - France
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1. Study Identification

Unique Protocol Identification Number
NCT04899284
Brief Title
Impact of Early Intensive Stimulation on Bimanual Function in Infants at High Risk of Unilateral CP (BB-BIM)
Acronym
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
Collaborators
Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL) - France, Hospices Civils de Lyon, Laboratoire de Biomécanique et Mécanique des Chocs (LBMC) - France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Unilateral cerebral palsy, Unilateral brain lesion, Infantile cerebral palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infants eligible for Early Intensive Bimanual Stimulation
Arm Type
Experimental
Arm 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
Intervention Type
Other
Intervention Name(s)
Early Intensive Bimanual Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hand Assessment in Infants (HAI)
Description
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).
Time Frame
Change from baseline at 2 months with a weekly evaluation
Secondary Outcome Measure Information:
Title
Actimetry
Description
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.
Time Frame
Change from baseline at 2 months with a weekly evaluation
Title
Goal Attainment Scales
Description
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.
Time Frame
Change from baseline at 2 months with a weekly evaluation
Title
Compliance
Description
Interview reporting the number of bimanual stimulation sessions actually completed during the past week (from T6 to T13 during the intervention phase).
Time Frame
Change from baseline at 2 months with a weekly evaluation
Title
Parent satisfaction questionnaire
Description
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.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Bard-Pondarré, OT
Organizational Affiliation
Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues. Lyon, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emmanuelle Chaléat-Valayer, PhD
Organizational Affiliation
Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues. Lyon, France
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Carole Vuillerot, PhD
Organizational Affiliation
Hopital Femme Mère Enfant, l'Escale MPR pédiatrique (Hospices Civils de Lyon). Bron, France
Official's Role
Study Director
Facility Information:
Facility Name
Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues
City
Lyon
ZIP/Postal Code
69005
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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