- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04899284
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)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rachel Bard-Pondarré, OT
- Phone Number: +33 (0)472384620
- Email: Rachel.BardPondarre@croix-rouge.fr
Study Contact Backup
- Name: Emmanuelle Chaléat-Valayer, PhD
- Phone Number: +33 (0)472384823
- Email: Emmanuelle.Chaleat-Valayer@croix-rouge.fr
Study Locations
-
-
-
Lyon, France, 69005
- Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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)
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
|
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)
Time Frame: 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).
|
Change from baseline at 2 months with a weekly evaluation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Actimetry
Time Frame: Change from baseline at 2 months with a weekly evaluation
|
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
Time Frame: Change from baseline at 2 months with a weekly evaluation
|
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
Time Frame: Change from baseline at 2 months with a weekly evaluation
|
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
Time Frame: 2 months
|
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
Collaborators
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)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BB-BIM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebral Palsy
-
Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
-
Northwestern UniversityActive, not recruitingCerebral Palsy | Diplegic Cerebral Palsy | Bilateral Cerebral PalsyUnited States
-
Centre Médico-Chirurgical de Réadaptation des Massues...RecruitingCerebral Palsy, Dyskinetic | Cerebral Palsy, Spastic | Infantile Hemiplegic Cerebral PalsyFrance
-
St Mary's University CollegeUniversity of GloucestershireUnknownCerebral Palsy | Cerebral Palsy Ataxic | Cerebral Palsy, MixedUnited Kingdom
-
Hilde FeysHasselt University; ETH Zurich; Curtin UniversityRecruitingHemiplegic Cerebral Palsy | Cerebral Palsy, SpasticBelgium
-
University of California, San FranciscoNational Institutes of Health (NIH)RecruitingDystonic Cerebral Palsy | Dyskinetic Cerebral PalsyUnited States
-
MTI UniversityEnrolling by invitationSpastic Diplegic Cerebral PalsyEgypt
-
East Carolina UniversityRecruitingHemiplegic Cerebral Palsy | Unilateral Cerebral Palsy | Remote Ischemic ConditioningUnited States
-
October 6 UniversityCompletedSpastic Cerebral Palsy | Spastic Hemiplegic Cerebral PalsyEgypt
-
Marmara UniversityUnknownCerebral Palsy, Spastic | Cerebral Palsy, Spastic, DiplegicTurkey
Clinical Trials on Early Intensive Bimanual Stimulation
-
Laval UniversityRecruiting
-
University of AlcalaEuropean University SpainCompleted
-
Samsung Medical CenterNot yet recruiting
-
University of NebraskaRecruitingHemiplegic Cerebral PalsyUnited States
-
University of LahoreCompleted
-
Teachers College, Columbia UniversityBurke Medical Research InstituteCompletedCerebral Palsy | Children | HemiplegiaUnited States
-
Université Catholique de LouvainRecruiting
-
Riphah International UniversityNot yet recruitingHemiplegic Cerebral PalsyPakistan
-
University of ZurichUnknownAutism Spectrum DisorderSwitzerland
-
Teachers College, Columbia UniversityEmory University; Thrasher Research FundCompletedCerebral Palsy | Children | Hemiplegia | PediatricUnited States