Cerebral PalsyNCT03930836
Implementation of a New Motor Skill Learning Therapeutic Device in Children With Cerebral Palsy Rehabilitation
A study testing Hand Arm Bimanual Intensive Therapy Including Lower Extremities and Conventional physical and occupational therapy in people with Cerebral Palsy, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Study of the efficiency of a new interactive interface to apply all the therapeutic principles of motor skill learning used in high dosage intensive interventions. Investigation of its effects on motor, functional and neuroplastic changes in children after high and low dosage intensive interventions using or not the… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Hand Arm Bimanual Intensive Therapy Including Lower Extremities and Conventional physical and occupational therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Jun 2018to 15 Jul 2020
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosis of unilateral cerebral palsy
- MACS level I, II or III
- GMFCS level I, II, III
Who cannot join
- unstable seizure
- cognitive deficit that prevent understanding of simple games
- botulinic toxin injection, surgery, or another unusual intervention in the 6 months preceding the study and for the duration of the study
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Institute of Neuroscience, Université catholique de Louvain
Brussels, 1200
About this study
Official title: Implementation of a New Interactive Interface Applying Motor Skill Learning Principles to Generate Motor, Functional and Neuroplastic Changes During High and Low Dosage Interventions in Children With Cerebral Palsy
Study of the efficiency of a new interactive interface to apply all the therapeutic principles of motor skill learning used in high dosage intensive interventions. Investigation of its effects on motor, functional and neuroplastic changes in children after high and low dosage intensive interventions using or not the interface.
- Conditions
- Cerebral Palsy
- Being tested
- Hand Arm Bimanual Intensive Therapy Including Lower Extremities, Conventional physical and occupational therapy
- Keywords
- motor function, motor skill learning
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Arm Bimanual Intensive Therapy Including Lower ExtremitiesBehavioural
Intensive intervention focusing on a constant bimanual coordination with a lower extremities and trunk control stimulation during play and functional activities. 50% of therapeutic time will be performed using the new interactive interface
Conventional physical and occupational therapyBehavioural
Conventional therapy (physical and occupational therapy) is mainly based on neurodevelopmental therapeutic principles. 50% of therapeutic time will be performed using the new interactive interface
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | high/low dosage intervention, intensive or not (motor function rehabilitation) Receives: Behavioral: Hand Arm Bimanual Intensive Therapy Including Lower Extremities; Behavioral: Conventional physical and occupational therapy |
| interface group | Experimental | high/low dosage intensive intervention using the interactive interface (motor function rehabilitation) Receives: Behavioral: Hand Arm Bimanual Intensive Therapy Including Lower Extremities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Assisting Hand Assessments score at 1 week post-camp
The Assisting Hand Assessment has been developped to measure and describe the efficacy of use of the affected hand of children with unilateral cerebral palsy bimanual activity performance. This is a standardized criterion-referenced test. It is conducted as a recorded semi-structured play session using specific objects usually used in a bimanual manner. With twenty-two test items, the child's performance is measured and obtain a sum score measure and a scaled score (percent scale).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Change from baseline 6 Minutes Walking Test score at 1 week post-camp
Measurement developped to assess the exercise tolerance and walking abilities by asking the patient to walk as much as possible during 6 minutes in a 30 meters long corridor
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Secondary outcomes (9)
Change from baseline Box and Blocks test score at 1 week post-camp
Test measuring hand function through the number of blocks transported in 1 minute from one part an other of a box placed in front of the child. Each hand tested separately
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Change from baseline Jebsen-Taylor Test of Hand Function score at 1 week post-camp
Measure of hand function/dexterity, through 7 activities simulating daily life activities. Each hand is tested separately and time to complete each activity is reported using a stopwatch.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Change from baseline Modified Cooper test at 1 week post-camp
Measurement of the stereognosis abilities.16 objects are placed in the hand and the child has to recognise the object only by touch. both hands are tested separately and time to recognise the objects is reported using a stopwatch
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Change from baseline ABILHAND-Kids questionnaire score at 1 week post-camp
questionnaire measuring performance of the child in daily life activities focusing on the upper extremities.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Change from baseline ACTIVLIM-CP questionnaire score at 1 week post-camp
questionnaire measuring performance of the child in daily life activities focusing on upper and lower extremities.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Change from baseline ABILOCO-Kids questionnaire at 1 week post-camp
questionnaire measuring performance of the child in daily life activities focusing on the lower extremities.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Change from baseline Pediatric Evaluation of Disability Inventory score at 1 week post-camp
questionnaire measuring performance of the child in daily life activities focusing on the upper extremities and lower extremities. Only the self-care domain will be assessed here
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Change from baseline Canadian Occupational Performance Measure scores at 1 week post-camp
The Canadian Occupational Performance Measure is a measure designed to capture the patient's self-perception of performance in everyday living, over time. It consist of a semi-structured interview were the patient elicits daily life activities performed with difficulties (self-care, nutrition, transfer, household management, school, work, transport, leisure, etc). Five activities are then chosen as the most important to improve and score on a 1 to 10 scale based on the actual patient's performance and satisfaction levels.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Change from baseline MHAVIE-child questionnaire score at 1 week post-camp
Questionnaire measuring social participation
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start14 Jun 2018
- Primary completion20 Jun 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yannick Bleyenheuft, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930836
- Sponsor's protocol ID
- B403201316810c
- Status last verified
- Dec 2020
- First submitted
- 21 Jun 2018
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saussez G, Bailly R, Araneda R, Paradis J, Ebner-Karestinos D, Klocker A, Sogbossi ES, Riquelme I, Brochard S, Bleyenheuft Y. Efficacy of integrating a semi-immersive virtual device in the HABIT-ILE intervention for children with unilateral cerebral palsy: a non-inferiority randomized controlled trial. J Neuroeng Rehabil. 2023 Jul 29;20(1):98. doi: 10.1186/s12984-023-01218-4.
PubMed 37516873
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a New Interactive Interface Applying Motor Skill Learning Principles to Generate Motor, Functional and Neuroplastic Changes During High and Low Dosage Interventions in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03930836
- Acronym / sponsor ID
- B403201316810c
- Conditions
- Cerebral Palsy
- Keywords
- motor function, motor skill learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 29 Apr 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.
Study of the efficiency of a new interactive interface to apply all the therapeutic principles of motor skill learning used in high dosage intensive interventions. Investigation of its effects on motor, functional and neuroplastic changes in children after high and low dosage intensive interventions using or not the interface.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Behavioral: Hand Arm Bimanual Intensive Therapy Including Lower Extremities, Behavioral: Conventional physical and occupational therapyhigh/low dosage intervention, intensive or not (motor function rehabilitation) |
| interface group | Experimental | Behavioral: Hand Arm Bimanual Intensive Therapy Including Lower Extremitieshigh/low dosage intensive intervention using the interactive interface (motor function rehabilitation) |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- diagnosis of unilateral cerebral palsy
- MACS level I, II or III
- GMFCS level I, II, III
Key exclusion criteria (3 listed)
- unstable seizure
- cognitive deficit that prevent understanding of simple games
- botulinic toxin injection, surgery, or another unusual intervention in the 6 months preceding the study and for the duration of the study
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 |
|---|---|---|
| Hand Arm Bimanual Intensive Therapy Including Lower ExtremitiesIntensive intervention focusing on a constant bimanual coordination with a lower extremities and trunk control stimulation during play and functional activities. 50% of therapeutic time will be performed using the new interactive interface | Behavioural | control group, interface group |
| Conventional physical and occupational therapyConventional therapy (physical and occupational therapy) is mainly based on neurodevelopmental therapeutic principles. 50% of therapeutic time will be performed using the new interactive interface | Behavioural | control group |
Primary outcome
Change from baseline Assisting Hand Assessments score at 1 week post-camp
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
The Assisting Hand Assessment has been developped to measure and describe the efficacy of use of the affected hand of children with unilateral cerebral palsy bimanual activity performance. This is a standardized criterion-referenced test. It is conducted as a recorded semi-structured play session using specific objects usually used in a bimanual manner. With twenty-two test items, the child's performance is measured and obtain a sum score measure and a scaled score (percent scale).
Change from baseline 6 Minutes Walking Test score at 1 week post-camp
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Measurement developped to assess the exercise tolerance and walking abilities by asking the patient to walk as much as possible during 6 minutes in a 30 meters long corridor
9 secondary outcomes
Change from baseline Box and Blocks test score at 1 week post-camp
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Change from baseline Jebsen-Taylor Test of Hand Function score at 1 week post-camp
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Change from baseline Modified Cooper test at 1 week post-camp
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Change from baseline ABILHAND-Kids questionnaire score at 1 week post-camp
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Change from baseline ACTIVLIM-CP questionnaire score at 1 week post-camp
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Change from baseline ABILOCO-Kids questionnaire at 1 week post-camp
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Change from baseline Pediatric Evaluation of Disability Inventory score at 1 week post-camp
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Change from baseline Canadian Occupational Performance Measure scores at 1 week post-camp
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Change from baseline MHAVIE-child questionnaire score at 1 week post-camp
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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 21 Dec 2020.
- Derived from this study: PubMed 37516873Saussez G, Bailly R, Araneda R, Paradis J, Ebner-Karestinos D, Klocker A, Sogbossi ES, Riquelme I, Brochard S, Bleyenheuft Y. Efficacy of integrating a semi-immersive virtual device in the HABIT-ILE intervention for children with unilateral cerebral palsy: a non-inferiority randomized controlled trial. J Neuroeng Rehabil. 2023 Jul 29;20(1):98. doi: 10.1186/s12984-023-01218-4.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Arm Bimanual Intensive Therapy Including Lower Extremities and Conventional physical and occupational therapy in people with Cerebral Palsy, run by Université Catholique de Louvain at 1 site in Belgium.
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 3 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 21 Dec 2020. 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 Belgium. 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?
Change from baseline Assisting Hand Assessments score at 1 week post-camp (time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up). The study lists 2 primary outcomes in all. 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 NCT03930836, which also lists 1 linked publication.
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 21 Dec 2020.