Unilateral Spastic Cerebral PalsyBE-APINCT03888443
"Be an Airplane Pilot": A Bimanual 3D Motion Analysis in Children With Unilateral Cerebral Palsy
An observational study of Unilateral Spastic Cerebral Palsy, run by Rennes University Hospital at 1 site in France.
Trial summary
Cerebral Palsy, in particular in its unilateral spastic form (uCP), is the main cause of motor disability in children, with a prevalence of 2/1000 births. These children have upper limb motor impairments that hinder the realization of activities of daily life in bimanual situations. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Unilateral Spastic Cerebral Palsy
- What is being tested?
- Bimanual 3D Motion Analysis " Be-API "
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2019to 26 Jun 2019
- 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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: * Children with unilateral spastic Cerebral Palsy and a sufficient level of manipulation followed in Physical Medicine and Rehabilitation in Rennes University Hospital * Safe volunteers will be recruited among children of the staff of the Rennes University Hospital (except children unit of Department of Physical Medicine and Rehabilitation) and the M2S laboratory.
Who may be able to join
- uCP children
- Child aged from 6 to 17,
- With Cerebral Palsy as defined by the SCPE, in unilateral spastic form.
- Sufficient level of manipulation (MACS score from I to III)
- TDC children
- Child aged from 6 to 17
Who cannot join
- uCP children
- Cognitive deficit altering the comprehension of the instructions or visual disturbances not allowing the visualization of the board game
- Upper limb pain (EVA score> 3),
- Botulinum toxin injections or upper extremity surgery in the 3 months before inclusion
- Contraindication to the use of botulinum toxins and no indications as mentioned in the recommendations HAS 2010
- TDC children
- Visual disturbances not allowing the visualization of the board game
- Upper limb pain (EVA score> 3),
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Bimanual and Scenarized 3D Motion Analysis Protocol of Upper Limbs in Children With Unilateral Spastic Cerebral Palsy
Cerebral Palsy, in particular in its unilateral spastic form (uCP), is the main cause of motor disability in children, with a prevalence of 2/1000 births. These children have upper limb motor impairments that hinder the realization of activities of daily life in bimanual situations. 3D motion analysis (3DMA) is an objective and precise tool, considered as the gold standard for gait analysis. The existing 3DMA protocols consist of movements too standardized, in unimanual situations away from gestures of everyday life, or have not been validated in bimanual situations.
In a preliminary study, a 3DMA bimanual protocol was study. it was composed of 4 tasks integrated into a game scenario to have more spontaneity of movements, similar to those experienced by children in daily life. It allows the exploration of all degrees of freedom of the upper limb. Results showed an excellent acceptability and within day reliability on 20 uCP children and 20 typically developing children (TDC) for funct
Read the detailed description
This is a prospective study for evaluation of a diagnostic and therapeutic tool.
"Be An Airplane Pilot" 3DMA:
The protocol consists of 5 complementary bimanual tasks that are integrated into a scenario game of "becoming an airplane pilot". It allows the exploration of all degrees of freedom of the UL kinematics of the non-dominant/hemiplegic.
The protocol will take place in a session that corresponds to the driving of an airplane and includes several tasks which consist of 5 repetitions of movements (= 5 cycles).
The kinematics of the trunk (flexion-extension, lateral flexions and rotations), shoulder (elevation, plane of elevation, rotations), elbow (flexion-extension and pronosupination) and wrist (flexion-extension and adduction/abduction) will be explored. The calculated kinematic parameters are the range of motion (ROM) and the maximum angle (MAX) of the degrees of freedom (DoF) of interest.
Group 1: uCP children without botulinum toxin injections
The 3DMA protocol will be performed in two sessions separated from 2-4 weeks to explore the between day reliability in uCP children.
During the first session, this will be associated to physiotherapist and occupational therapist evaluation in order to correlate kinematic parameters to clinical score. During the first session, this will be associated to clinical assessment (muscle strength and tone, pinch, grasp) by a physiotherapist and bimanual performance-based measures (Assisting Hand Assessment (AHA) and Abilhand-kids) by an occupational therapist.
Group 2: uCP children with botulinum toxin injections
Five uCP children will perform the BE-API protocol before and after botulinum toxin injections in the upper limb. This treatment is used for its effect on the local reduction of spasticity after intramuscular injection. It is usually proposed to these children every 6-8 months.
Visit 1 is similar to Group 1 with 3DMA, occupational therapy and physiotherapy.
The second 3DMA will be done during the planned visit for toxin injections (2 to 4 weeks after visit 1) and before treatment administration. Injections of botulinum toxins will be followed by rehabilitation's intensification for 4 weeks (physiotherapy and home exercise) according to the usual care of treated patients.
During Visit 3, 4 to 6 weeks after treatment by botulinum toxin injections, children will have 3D analysis for the third time, with assessment in physiotherapy and occupational therapy, comparable to the Visit 1.
Group 3: healthy volunteers (TDC children)
Their participation in the study will consist of a single visit, during which they will realize the 3DMA protocol only.
Clinical measures
For uCP children, with or without toxin injections, descriptive characteristics such as age, sex, hemiplegic side, as well as Manual Ability Classification System (MACS), Bimanual Fine Motor Function (BFMF) and Modified House Classification will be collected in consultation.
The physiotherapy will do a clinical examination of the upper limbs: passive and active measurement of the range of motion by goniometry, muscle strength, motor selectivity, spasticity, grasp and pinch test, and sensitivity.
The evaluation of the bimanual performance will be carried out by a certified occupational therapist with a validated scale: the Assisting Hand Assessment (AHA) and a questionnaire: the Abiland-Kids (10) which will be filled with the parents
- Conditions
- Unilateral Spastic Cerebral Palsy
- Being tested
- Bimanual 3D Motion Analysis " Be-API "
- Keywords
- Unilateral cerebral palsy, three-dimensional movement analysis, upper limb, bimanual task, bimanual performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bimanual 3D Motion Analysis " Be-API "Device
Movements will be measured using an optoelectronic system (12 cameras) which captures the displacement of 26 markers placed on the upper limbs and trunk of the child, according to the standards of the International Society of Biomechanics.
The child is installed on a chair and table height (equipment adapted and approved for pediatrics). A game board is installed in front of the child, with objects to handle, set and placed according to its anthropometry (joystick, steering wheel, buzzer, board, chip).
| Study group | Role | What they receive |
|---|---|---|
| uCP children | 15 Children aged from 6 to 17 with unilateral spastic Cerebral Palsy and a sufficient level of manipulation will realize the bimanual protocol twice separated from 2 to 4 weeks Receives: Device: Bimanual 3D Motion Analysis " Be-API " | |
| uCP children with botulinum toxin injections | 5 children aged from 6 to 17 with unilateral spastic Cerebral Palsy and a sufficient level of manipulation will realize the bimanual protocol three times Receives: Device: Bimanual 3D Motion Analysis " Be-API " | |
| healthy volunteers (TDC children) | 20 children aged from 6 to 17 (healthy volunteers) will realize the bimanual protocol once Receives: Device: Bimanual 3D Motion Analysis " Be-API " |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: Between-day reliability of kinematic parameters (MAX and ROM) will be studied by calculating a between-day Intra-class Correlation Coefficient (ICC) and the Standard Measurement Errors (SEM) from the ICC.
Two kinematic parameters will be studied: MAX (Maximum angle value) and ROM (Range of Motion) parameters, measured in degrees.
Outcome measures :
- Between-day reliability of MAX will be studied by calculating a between-day Intra-class Correlation Coefficient (ICC).
- Between-day reliability of ROM will be studied by calculating a between-day Intra-class Correlation Coefficient (ICC).
From ICC, Standard Measurement Errors (SEM) can be calculated. SEM represents from how much degree, it can be considered that the fluctuation is unrelated to chance.
Measured: At the end of the participation to the study for each uCP children (2- 4 weeks maximum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start13 Feb 2019
- Primary completion26 Jun 2019
- Study completion26 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unilateral Spastic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- M2S lab, IPSEN, biopharmaceutical group (financial support)
- Responsible party
- Sponsor
- Investigators
- Isabelle bonan, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888443
- Sponsor's protocol ID
- 35RC18_8849_BE-API
- Other IDs
- 2018-A03290-55
- Acronym
- BE-API
- Status last verified
- Feb 2019
- First submitted
- 15 Mar 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cacioppo M, Lempereur M, Marin A, Rauscent H, Cretual A, Brochard S, Bonan I. Motor patterns of the impaired upper limb in children with unilateral cerebral palsy performing bimanual tasks. Clin Biomech (Bristol). 2022 Jul;97:105710. doi: 10.1016/j.clinbiomech.2022.105710. Epub 2022 Jun 22.
PubMed 35763887Cacioppo M, Marin A, Rauscent H, Le Pabic E, Gaillard F, Brochard S, Garlantezec R, Cretual A, Bonan I. A new child-friendly 3D bimanual protocol to assess upper limb movement in children with unilateral cerebral palsy: Development and validation. J Electromyogr Kinesiol. 2020 Dec;55:102481. doi: 10.1016/j.jelekin.2020.102481. Epub 2020 Oct 10.
PubMed 33091791
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Bimanual and Scenarized 3D Motion Analysis Protocol of Upper Limbs in Children With Unilateral Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03888443
- Acronym / sponsor ID
- BE-API / 35RC18_8849_BE-API
- Conditions
- Unilateral Spastic Cerebral Palsy
- Keywords
- Unilateral cerebral palsy, three-dimensional movement analysis, upper limb, bimanual task, bimanual performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- M2S lab, IPSEN, biopharmaceutical group (financial support)
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 25 Mar 2019 (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, in particular in its unilateral spastic form (uCP), is the main cause of motor disability in children, with a prevalence of 2/1000 births. These children have upper limb motor impairments that hinder the realization of activities of daily life in bimanual situations. 3D motion analysis (3DMA) is an objective and precise tool, considered as the gold standard for gait analysis. The existing 3DMA protocols consist of movements too standardized, in unimanual situations away from gestures of everyday life, or have not been validated in bimanual situations.
In a preliminary study, a 3DMA bimanual protocol was study. it was composed of 4 tasks integrated into a game scenario to have more spontaneity of movements, similar to those experienced by children in daily life. It allows the exploration of all degrees of freedom of the upper limb. Results showed an excellent acceptability and within day reliability on 20 uCP children and 20 typically developing children (TDC) for funct
Detailed description
This is a prospective study for evaluation of a diagnostic and therapeutic tool.
"Be An Airplane Pilot" 3DMA:
The protocol consists of 5 complementary bimanual tasks that are integrated into a scenario game of "becoming an airplane pilot". It allows the exploration of all degrees of freedom of the UL kinematics of the non-dominant/hemiplegic.
The protocol will take place in a session that corresponds to the driving of an airplane and includes several tasks which consist of 5 repetitions of movements (= 5 cycles).
The kinematics of the trunk (flexion-extension, lateral flexions and rotations), shoulder (elevation, plane of elevation, rotations), elbow (flexion-extension and pronosupination) and wrist (flexion-extension and adduction/abduction) will be explored. The calculated kinematic parameters are the range of motion (ROM) and the maximum angle (MAX) of the degrees of freedom (DoF) of interest.
Group 1: uCP children without botulinum toxin injections
The 3DMA protocol will be performed in two sessions separated from 2-4 weeks to explore the between day reliability in uCP children.
During the first session, this will be associated to physiotherapist and occupational therapist evaluation in order to correlate kinematic parameters to clinical score. During the first session, this will be associated to clinical assessment (muscle strength and tone, pinch, grasp) by a physiotherapist and bimanual performance-based measures (Assisting Hand Assessment (AHA) and Abilhand-kids) by an occupational therapist.
Group 2: uCP children with botulinum toxin injections
Five uCP children will perform the BE-API protocol before and after botulinum toxin injections in the upper limb. This treatment is used for its effect on the local reduction of spasticity after intramuscular injection. It is usually proposed to these children every 6-8 months.
Visit 1 is similar to Group 1 with 3DMA, occupational therapy and physiotherapy.
The second 3DMA will be done during the planned visit for toxin injections (2 to 4 weeks after visit 1) and before treatment administration. Injections of botulinum toxins will be followed by rehabilitation's intensification for 4 weeks (physiotherapy and home exercise) according to the usual care of treated patients.
During Visit 3, 4 to 6 weeks after treatment by botulinum toxin injections, children will have 3D analysis for the third time, with assessment in physiotherapy and occupational therapy, comparable to the Visit 1.
Group 3: healthy volunteers (TDC children)
Their participation in the study will consist of a single visit, during which they will realize the 3DMA protocol only.
Clinical measures
For uCP children, with or without toxin injections, descriptive characteristics such as age, sex, hemiplegic side, as well as Manual Ability Classification System (MACS), Bimanual Fine Motor Function (BFMF) and Modified House Classification will be collected in consultation.
The physiotherapy will do a clinical examination of the upper limbs: passive and active measurement of the range of motion by goniometry, muscle strength, motor selectivity, spasticity, grasp and pinch test, and sensitivity.
The evaluation of the bimanual performance will be carried out by a certified occupational therapist with a validated scale: the Assisting Hand Assessment (AHA) and a questionnaire: the Abiland-Kids (10) which will be filled with the parents
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| uCP children | – | Device: Bimanual 3D Motion Analysis " Be-API "15 Children aged from 6 to 17 with unilateral spastic Cerebral Palsy and a sufficient level of manipulation will realize the bimanual protocol twice separated from 2 to 4 weeks |
| uCP children with botulinum toxin injections | – | Device: Bimanual 3D Motion Analysis " Be-API "5 children aged from 6 to 17 with unilateral spastic Cerebral Palsy and a sufficient level of manipulation will realize the bimanual protocol three times |
| healthy volunteers (TDC children) | – | Device: Bimanual 3D Motion Analysis " Be-API "20 children aged from 6 to 17 (healthy volunteers) will realize the bimanual protocol once |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- * Children with unilateral spastic Cerebral Palsy and a sufficient level of manipulation followed in Physical Medicine and Rehabilitation in Rennes University Hospital * Safe volunteers will be recruited among children of the staff of the Rennes University Hospital (except children unit of Department of Physical Medicine and Rehabilitation) and the M2S laboratory.
Key inclusion criteria (6 listed)
- uCP children
- Child aged from 6 to 17,
- With Cerebral Palsy as defined by the SCPE, in unilateral spastic form.
- Sufficient level of manipulation (MACS score from I to III)
- TDC children
Key exclusion criteria (8 listed)
- uCP children
- Cognitive deficit altering the comprehension of the instructions or visual disturbances not allowing the visualization of the board game
- Upper limb pain (EVA score> 3),
- Botulinum toxin injections or upper extremity surgery in the 3 months before inclusion
- Contraindication to the use of botulinum toxins and no indications as mentioned in the recommendations HAS 2010
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 |
|---|---|---|
| Bimanual 3D Motion Analysis " Be-API "Movements will be measured using an optoelectronic system (12 cameras) which captures the displacement of 26 markers placed on the upper limbs and trunk of the child, according to the standards of the International Society of Biomechanics. The child is installed on a chair and table height (equipment adapted and approved for pediatrics). A game board is installed in front of the child, with objects to handle, set and placed according to its anthropometry (joystick, steering wheel, buzzer, board, chip). | Device | healthy volunteers (TDC children), uCP children, uCP children with botulinum toxin injections |
Primary outcome
Primary outcome: Between-day reliability of kinematic parameters (MAX and ROM) will be studied by calculating a between-day Intra-class Correlation Coefficient (ICC) and the Standard Measurement Errors (SEM) from the ICC.
Time frame: At the end of the participation to the study for each uCP children (2- 4 weeks maximum)
Two kinematic parameters will be studied: MAX (Maximum angle value) and ROM (Range of Motion) parameters, measured in degrees. Outcome measures : * Between-day reliability of MAX will be studied by calculating a between-day Intra-class Correlation Coefficient (ICC). * Between-day reliability of ROM will be studied by calculating a between-day Intra-class Correlation Coefficient (ICC). From ICC, Standard Measurement Errors (SEM) can be calculated. SEM represents from how much degree, it can be considered that the fluctuation is unrelated to chance.
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 23 Sep 2019.
- Derived from this study: PubMed 35763887Cacioppo M, Lempereur M, Marin A, Rauscent H, Cretual A, Brochard S, Bonan I. Motor patterns of the impaired upper limb in children with unilateral cerebral palsy performing bimanual tasks. Clin Biomech (Bristol). 2022 Jul;97:105710. doi: 10.1016/j.clinbiomech.2022.105710. Epub 2022 Jun 22.
- Derived from this study: PubMed 33091791Cacioppo M, Marin A, Rauscent H, Le Pabic E, Gaillard F, Brochard S, Garlantezec R, Cretual A, Bonan I. A new child-friendly 3D bimanual protocol to assess upper limb movement in children with unilateral cerebral palsy: Development and validation. J Electromyogr Kinesiol. 2020 Dec;55:102481. doi: 10.1016/j.jelekin.2020.102481. Epub 2020 Oct 10.
- Individual participant dataSharing planned: Undecided
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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.
Isabelle bonan principal investigator
Rennes University Hospital
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 Unilateral Spastic Cerebral Palsy, run by Rennes University Hospital 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 8 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 23 Sep 2019. 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?
Primary outcome: Between-day reliability of kinematic parameters (MAX and ROM) will be studied by calculating a between-day Intra-class Correlation Coefficient (ICC) and the Standard Measurement Errors (SEM) from the ICC. (time frame: At the end of the participation to the study for each uCP children (2- 4 weeks maximum)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03888443, which also lists 2 linked publications.
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 23 Sep 2019.