Cerebral Palsy InfantileBE API CHANGENCT05691556
Study of the Sensitivity to Change of a Bimanual 3D Analysis Protocol for the Assessment of Upper Limb Movement in Children With Cerebral Palsy Before and After Therapies
An observational study of Cerebral Palsy Infantile, run by University Hospital, Brest at 1 site in France.
Trial summary
Cerebral Palsy is the most common cause of motor disability in children. It can lead to a deficit of the upper limb which alters the realization of daily activities, in particular in bimanual situations, and eventually leads to a decrease in their participation. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cerebral Palsy Infantile
- What is being tested?
- HABIT ILE rehabilitation course and botulinum toxin injections
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jul 2020to 31 Dec 2023
- Phase
- Observational
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with cerebral palsy with motor impairment of the upper limb(s), seen in consultation and included in a HABIT-ILE therapeutic program and/or botulinum toxin injections.
Who may be able to join
- Child between the ages of 5 and 18,
- Child with cerebral palsy as defined by the CSEP
- Level of manipulation sufficient to perform the tasks of the 3D protocol (MACS score I to III included),
- For whom the HABIT-ILE therapeutic program and/or botulinum toxin injection is prescribed
- Affiliated via his/her parents to a social security plan,
- No opposition formulated by the holders of parental authority and the child
Who cannot join
- Child with unilateral or bilateral spastic cerebral palsy
- Cognitive deficits hindering the comprehension of instructions or visual disorders not allowing the visualization of the game board,
- Pain in the upper limb (VAS score>3),
- Contraindications to the use of botulinum toxins and absence of indications as mentioned in the HAS 2010 recommendations
- Patients under legal protection (guardianship, curatorship, ...)
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Brest
Brest, 29200
Marine Cacioppo, marine.cacioppo@chu-brest.fr
About this study
Cerebral Palsy is the most common cause of motor disability in children. It can lead to a deficit of the upper limb which alters the realization of daily activities, in particular in bimanual situations, and eventually leads to a decrease in their participation.
Three-dimensional (3D) movement analysis is a tool that provides an accurate and objective measurement of movement. This technology allows us to understand and characterize movement anomalies in order to guide and adapt therapies to the upper limb. The majority of 3D upper limb analysis protocols used to measure the effect of interventions, such as botulinum toxin injections indicated for the treatment of spasticity or other innovative rehabilitative therapies, are unimanual and do not study bimanual function, which is more representative of the actual use of the upper limbs in daily life.
Recently, a 3D bimanual analysis protocol called "Be An Airplane Pilot" (BE-API), taking place in an innovative play context, has been developed and validated in PC children. The 2nd version of the protocol (BE API 2.0) also allowed the exploration of new parameters in a bimanual situation such as the fluidity and the trajectory of the movement. In order to determine the interest of the BE API 2.0 protocol in routine clinical evaluation of the upper limbs, its sensitivity to change, i.e. its capacity to detect modifications caused by a therapy on the movements of the upper limbs is necessary (e.g.: Hand and Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT ILE), botulinum toxin injections).
- Conditions
- Cerebral Palsy Infantile
- Being tested
- HABIT ILE rehabilitation course, botulinum toxin injections
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HABIT ILE rehabilitation courseProcedure or surgery
The HABIT-ILE course, created by the Belgian team of Prof. Yannick Bleyenheuft, is a rehabilitation of the upper and lower limbs, following the concepts of structured motor learning and intensive therapy. The internships last 2 weeks and are performed on a multi-year basis since 2018 at the SSR pediatric, Fondation Ildys, Site de Ty Yann in Brest.
In this group, upper limb assessments are performed the week before and the week after the HABIT ILE training course
botulinum toxin injectionsProcedure or surgery
Toxin injections are used for their effect on the local reduction of spasticity after intramuscular injection. This treatment is usually offered to these children every 6 months or so for functional improvement.
These botulinum toxin injections are organized on a weekly basis in a pediatric day hospital (CHU Morvan in Brest).
In this group, upper limb assessments were performed 0-2 weeks before and then 4 to 6 weeks after the botulinum toxin injections (see table below), at the peak of the toxin's efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Children CP | Children with cerebral palsy with motor impairment of the upper limb(s), seen in consultation and included in a HABIT-ILE therapeutic program and/or botulinum toxin injections Receives: Procedure: HABIT ILE rehabilitation course; Procedure: botulinum toxin injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the sensitivity to change of the BE API 2.0 bimanual 3D analysis protocol by measuring the change in the severity of movement deviation in the upper limb before and after therapy
The Arm Profile score is a kinematic index that reflects the severity of the subject's movement deviation compared to the "normal" deviation of healthy children.
Measured: 2 months
Secondary outcomes (5)
To measure the change induced by the therapy on the parameters measured in movement analysis (kinematic), clinical and functional measures at the deficient MS (comparison before and after therapy).
kinematic parameters measured in motion analysis with the BE API 2.0 protocol
Measured: 2 months
To measure the change induced by the therapy on the parameters measured in movement analysis (spatio-temporal), clinical and functional measures at the deficient MS (comparison before and after therapy).
Spatio-temporal parameters measured in motion analysis with the BE API 2.0 protocol
Measured: 2 months
To study the association between the parameters measured in motion analysis clinical/functional measurements (kinematics and spatio-temporal parameters) before and after therapy.
Correlation of motion analysis measurements (kinematics and spatio-temporal parameters) measured with the BE API 2.0 protocol before and after therapy to clinical.
Measured: 2 months
To study the association between the parameters measured in motion analysis with the BE API 2.0 protocol (kinematics and spatio-temporal parameters) before and after therapy.
Correlation of motion analysis measurements (kinematics and spatio-temporal parameters) measured with the BE API 2.0 protocol before and after functional measurements
Measured: 2 months
Compare the dominant and non-dominant upper limb of PC children on parameters measured in motion analysis with the BE API 2.0 protocol (kinematic and spatio-temporal), before and after therapy.
Compare motion analysis measurements (kinematics and spatiotemporal parameters) of dominant and non-dominant MS measured with the BE API 2.0 protocol before and after therapy
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 posted20 Jan 2023
- Study start16 Jul 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy InfantileStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691556
- Sponsor's protocol ID
- 29BRC21.0299 - BE API CHANGE
- Acronym
- BE API CHANGE
- Status last verified
- Jan 2023
- First submitted
- 2 Jan 2023
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Sensitivity to Change of a Bimanual 3D Analysis Protocol for the Assessment of Upper Limb Movement in Children With Cerebral Palsy Before and After Therapies
- ClinicalTrials.gov ID
- NCT05691556
- Acronym / sponsor ID
- BE API CHANGE / 29BRC21.0299 - BE API CHANGE
- Conditions
- Cerebral Palsy Infantile
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Jan 2023 (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.
Cerebral Palsy is the most common cause of motor disability in children. It can lead to a deficit of the upper limb which alters the realization of daily activities, in particular in bimanual situations, and eventually leads to a decrease in their participation.
Three-dimensional (3D) movement analysis is a tool that provides an accurate and objective measurement of movement. This technology allows us to understand and characterize movement anomalies in order to guide and adapt therapies to the upper limb. The majority of 3D upper limb analysis protocols used to measure the effect of interventions, such as botulinum toxin injections indicated for the treatment of spasticity or other innovative rehabilitative therapies, are unimanual and do not study bimanual function, which is more representative of the actual use of the upper limbs in daily life.
Recently, a 3D bimanual analysis protocol called "Be An Airplane Pilot" (BE-API), taking place in an innovative play context, has been developed and validated in PC children. The 2nd version of the protocol (BE API 2.0) also allowed the exploration of new parameters in a bimanual situation such as the fluidity and the trajectory of the movement. In order to determine the interest of the BE API 2.0 protocol in routine clinical evaluation of the upper limbs, its sensitivity to change, i.e. its capacity to detect modifications caused by a therapy on the movements of the upper limbs is necessary (e.g.: Hand and Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT ILE), botulinum toxin injections).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children CP | – | Procedure: HABIT ILE rehabilitation course, Procedure: botulinum toxin injectionsChildren with cerebral palsy with motor impairment of the upper limb(s), seen in consultation and included in a HABIT-ILE therapeutic program and/or botulinum toxin injections |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with cerebral palsy with motor impairment of the upper limb(s), seen in consultation and included in a HABIT-ILE therapeutic program and/or botulinum toxin injections.
Key inclusion criteria (6 listed)
- Child between the ages of 5 and 18,
- Child with cerebral palsy as defined by the CSEP
- Level of manipulation sufficient to perform the tasks of the 3D protocol (MACS score I to III included),
- For whom the HABIT-ILE therapeutic program and/or botulinum toxin injection is prescribed
- Affiliated via his/her parents to a social security plan,
Key exclusion criteria (6 listed)
- Child with unilateral or bilateral spastic cerebral palsy
- Cognitive deficits hindering the comprehension of instructions or visual disorders not allowing the visualization of the game board,
- Pain in the upper limb (VAS score>3),
- Contraindications to the use of botulinum toxins and absence of indications as mentioned in the HAS 2010 recommendations
- Patients under legal protection (guardianship, curatorship, ...)
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 |
|---|---|---|
| HABIT ILE rehabilitation courseThe HABIT-ILE course, created by the Belgian team of Prof. Yannick Bleyenheuft, is a rehabilitation of the upper and lower limbs, following the concepts of structured motor learning and intensive therapy. The internships last 2 weeks and are performed on a multi-year basis since 2018 at the SSR pediatric, Fondation Ildys, Site de Ty Yann in Brest. In this group, upper limb assessments are performed the week before and the week after the HABIT ILE training course | Procedure or surgery | Children CP |
| botulinum toxin injectionsToxin injections are used for their effect on the local reduction of spasticity after intramuscular injection. This treatment is usually offered to these children every 6 months or so for functional improvement. These botulinum toxin injections are organized on a weekly basis in a pediatric day hospital (CHU Morvan in Brest). In this group, upper limb assessments were performed 0-2 weeks before and then 4 to 6 weeks after the botulinum toxin injections (see table below), at the peak of the toxin's efficacy. | Procedure or surgery | Children CP |
Primary outcome
To study the sensitivity to change of the BE API 2.0 bimanual 3D analysis protocol by measuring the change in the severity of movement deviation in the upper limb before and after therapy
Time frame: 2 months
The Arm Profile score is a kinematic index that reflects the severity of the subject's movement deviation compared to the "normal" deviation of healthy children.
5 secondary outcomes
To measure the change induced by the therapy on the parameters measured in movement analysis (kinematic), clinical and functional measures at the deficient MS (comparison before and after therapy).
Time frame: 2 months
To measure the change induced by the therapy on the parameters measured in movement analysis (spatio-temporal), clinical and functional measures at the deficient MS (comparison before and after therapy).
Time frame: 2 months
To study the association between the parameters measured in motion analysis clinical/functional measurements (kinematics and spatio-temporal parameters) before and after therapy.
Time frame: 2 months
To study the association between the parameters measured in motion analysis with the BE API 2.0 protocol (kinematics and spatio-temporal parameters) before and after therapy.
Time frame: 2 months
Compare the dominant and non-dominant upper limb of PC children on parameters measured in motion analysis with the BE API 2.0 protocol (kinematic and spatio-temporal), before and after therapy.
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for Cerebral Palsy Infantile
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
RecruitingObservational study
Study of Sagittal Pelvic Statics in the Sitting Position in Children With Cerebral Palsy
Cerebral Palsy Infantile
Not yet recruiting
Using Power Mobility Training to Promote Arm & Hand Function in Children With Cerebral Palsy
Cerebral Palsy, Hemiplegia, Infantile
Not yet recruiting
Coaching, Learning, Empowerment in Cerebral Palsy - a 6-Week Integrated PT/OT Caregiver "Primer" Bootcamp for Infants Diagnosed With or at High Risk for Cerebral Palsy
Cerebral Palsy, Cerebral Palsy (CP)
RecruitingObservational study
Motor-voice Assessment in Infants (MAMI)
Cerebral Palsy Infantile, Pre-Term
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy Infantile, run by University Hospital, Brest 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 20 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marine Cacioppo (02 98 02 11 36 ext. +33, marine.cacioppo@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study the sensitivity to change of the BE API 2.0 bimanual 3D analysis protocol by measuring the change in the severity of movement deviation in the upper limb before and after therapy (time frame: 2 months). 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 20 Jan 2023.