Cerebral PalsyBB-BIMNCT04899284
Impact of Early Intensive Stimulation on Bimanual Function in Infants at High Risk of Unilateral CP (BB-BIM)
A study testing Early Intensive Bimanual Stimulation in people with Cerebral Palsy, run by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 months
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Early Intensive Bimanual Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 21 Apr 2021to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Prematurity
- Lack of interest suggesting underlying associated disorders
- Active epilepsy
Trial locations and contacts
1 site in 1 country.
France1 site
Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues
Lyon, 69005
About this study
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)
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Early Intensive Bimanual Stimulation
- Keywords
- Unilateral cerebral palsy, Unilateral brain lesion, Infantile cerebral palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Intensive Bimanual StimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Infants eligible for Early Intensive Bimanual Stimulation | Experimental | 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 Receives: Other: Early Intensive Bimanual Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from baseline at 2 months with a weekly evaluation
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start21 Apr 2021
- Primary completion1 May 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
- Sponsor type
- University, hospital or other
- Collaborators
- Groupement des Hôpitaux de l'Institut Catholique de Lille, Hospices Civils de Lyon, Laboratoire de Biomécanique et Mécanique des Chocs (LBMC) - France
- Responsible party
- Sponsor
- Investigators
- Rachel Bard-Pondarré, OT, Principal investigator, Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues. Lyon, FranceEmmanuelle Chaléat-Valayer, PhD, Study director, Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues. Lyon, FranceCarole Vuillerot, PhD, Study director, Hopital Femme Mère Enfant, l'Escale MPR pédiatrique (Hospices Civils de Lyon). Bron, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899284
- Sponsor's protocol ID
- BB-BIM
- Acronym
- BB-BIM
- Status last verified
- May 2023
- First submitted
- 18 May 2021
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04899284
- Acronym / sponsor ID
- BB-BIM / BB-BIM
- Conditions
- Cerebral Palsy
- Keywords
- Unilateral cerebral palsy, Unilateral brain lesion, Infantile cerebral palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge FrançaiseUniversity, hospital or other
- Collaborators
- Groupement des Hôpitaux de l'Institut Catholique de Lille, Hospices Civils de Lyon, Laboratoire de Biomécanique et Mécanique des Chocs (LBMC) - France
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants eligible for Early Intensive Bimanual Stimulation | Experimental | Other: Early Intensive Bimanual StimulationInfants 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 |
Who may qualify
- Ages
- 3 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Prematurity
- Lack of interest suggesting underlying associated disorders
- Active epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Intensive Bimanual StimulationEarly 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. | Other | Infants eligible for Early Intensive Bimanual Stimulation |
Primary outcome
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).
4 secondary outcomes
Actimetry
Time frame: 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
Compliance
Time frame: Change from baseline at 2 months with a weekly evaluation
Parent satisfaction questionnaire
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Bard-Pondarré, OT principal investigator
Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues. Lyon, France
Emmanuelle Chaléat-Valayer, PhD study director
Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues. Lyon, France
Carole Vuillerot, PhD study director
Hopital Femme Mère Enfant, l'Escale MPR pédiatrique (Hospices Civils de Lyon). Bron, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Intensive Bimanual Stimulation in people with Cerebral Palsy, run by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand Assessment in Infants (HAI) (time frame: Change from baseline at 2 months with a weekly evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.