Cerebral PalsyNCT04403464
Effect of a New Interactive Device on the Motor and Functional Abilities of Children With Bilateral Cerebral Palsy
A study testing HABIT-ILE with REAtouch® and HABIT-ILE without REAtouch® in people with Cerebral Palsy, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Recent research has shown that interventions with assistive technologies lead to an improvement in the motor and functional abilities of children with cerebral palsy (CP). REAtouch® is a new interactive interface based on motor skill learning principles. 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?
- HABIT-ILE with REAtouch® and HABIT-ILE without REAtouch®
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 26 May 2020to 20 Dec 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed bilateral cerebral palsy,
- MACS levels from I to III,
- GMFCS levels from I to III,
- Ability to follow instructions and complete testing.
Who cannot join
- Orthopedic surgery, botulinum toxin injections or another unusual intervention less than 6 months before or within the study period.
- Unstable seizure
- Severe visual or cognitive impairments likely to interfere with intervention or testing session completion
Trial locations and contacts
1 site in 1 country.
Seyma Kilcioglu, PhD Student contact
Belgium1 site, 1 recruiting
- Recruiting
Institute of Neuroscience, UCLouvain
Brussels, 1200
Yannick Bleyenheuft, PT, PhD, yannick.bleyenheuft@uclouvain.be
Seyma Kilcioglu, PhD Student, seyma.kilcioglu@student.uclouvain.be
About this study
Official title: The Effect of Using a New Interactive Device Based on Motor Skill Learning Principles on the Motor and Functional Abilities of Children With Bilateral Cerebral Palsy
Recent research has shown that interventions with assistive technologies lead to an improvement in the motor and functional abilities of children with cerebral palsy (CP). REAtouch® is a new interactive interface based on motor skill learning principles. Its efficiency during intensive motor skill learning interventions has never been tested in children with bilateral cerebral palsy.
Therefore, the study aims to investigate the efficiency of using a virtual reality tool to provide a motor skill learning intervention in a randomized trial.
Read the detailed description
Recent research has shown that interventions with assistive technologies could lead to an improvement in the motor and functional abilities of children with cerebral palsy (CP). However they usually miss the functional motor skill learning qualities to match the changes observed in high intensity motor skill learning based interventions.REAtouch® is a new interactive interface based on motor skill learning principles that could be implemented in intensive interventions.
Therefore, the study aims to investigate the effects of intensive interventions with or without the interface on the motor and functional abilities of children with bilateral CP.
- Conditions
- Cerebral Palsy
- Being tested
- HABIT-ILE with REAtouch®, HABIT-ILE without REAtouch®
- Keywords
- motor skill learning, intensive therapy, selective voluntary motor control, cerebral palsy, assistive technology, therapeutic device
- 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 with REAtouch®Behavioural
65h HABIT-ILE including 30h REAtouch®
HABIT-ILE without REAtouch®Behavioural
65h HABIT-ILE
| Study group | Role | What they receive |
|---|---|---|
| HABIT-ILE with REAtouch® | Experimental | Hand and Arm Bimanual Intensive Therapy Including Lower Extremities with an interactive device Receives: Behavioral: HABIT-ILE with REAtouch® |
| HABIT-ILE without REAtouch® | Active comparator | Hand and Arm Bimanual Intensive Therapy Including Lower Extremities Receives: Behavioral: HABIT-ILE without REAtouch® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Gross Motor Function Measure (GMFM-66):
The GMFM has been developed to measure the change in gross motor function over time in children with cerebral palsy.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
Changes in ABILHAND-Kids Questionnaire
This ABILHAND-Kids Questionnaire has been developed to assess a child's unimanual and bimanual upper limb activities. It ranges from - 6 to +6 logits (higher score means better performance).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
Secondary outcomes (22)
Changes in Test of Arm Selective Control (TASC)
The TASC is an upper limb selective motor control evaluation tool including eight motions in each arm and up to three attempts are allowed for each motion. After completion of the best attempt, points ranging from 0 (absent), 1 (impaired) to 2 (normal) are recorded for each joint depending on the movement properties and descriptors of the test.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
Changes in Selective Control Assessment of the Lower Extremity (SCALE)
The SCALE was designed to evaluate lower limb selective motor control of children with cerebral palsy. The SCALE includes testing of five reciprocal lower extremity movements. SVMC is graded at each joint as 'Normal' (2 points), 'Impaired' (1 point), or 'Unable' (0 points).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
Changes in 6 Minutes Walking Test (6MWT)
The 6 Minutes Walking Test measures the distance that the patient walk as much as possible within a period of 6-minutes in a 30 meters long corridor.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
Changes in Box and Blocks test (BBT)
The BBT is a test of gross manual dexterity. Each hand is tested individually and the BBT is scored through the number of blocks carried over the partition from one part to another part of a box during the one-minute trial period.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
Changes in Jebsen-Taylor Test
The Jebsen-Taylor Test assesses uni-manual hand function, through 7 subtests simulating daily life activities. The test assesses speed, not quality of performance 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
Changes in Modified Cooper test
The Modified Cooper test is a modified version of The Manual Form Perception Test, which evaluates stereognosis through 16 objects. 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
Changes in ACTIVLIM-CP Questionnaire
The ACTIVLIM-CP Questionnaire measures a patient's ability to perform daily activities requiring the use of the upper and/or the lower limbs through 42 items specific to patients with cerebral palsy. It ranges from - 5 to +5 logits (higher score means better performance).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
Changes in ABILOCO-Kids Questionnaire
The ABILOCO-Kids Questionnaire measures a patient's ability to perform daily activities requiring the use of the lower limbs through 10 items specific to patients with cerebral palsy. It ranges from - 4 to +4 logits (higher score means better performance).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
Changes in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)
The PEDI-CAT is the new version of the Pediatric Evaluation of Disability Inventory (PEDI). The PEDI-CAT is comprised of 276 functional activities acquired throughout infancy, childhood and young adulthood. Based on the nternational Classification of Functioning, Disability and Health for Children and Youth (ICF-CY) model, the PEDI-CAT contents provide information about the activities and participation component. It ranges from 0 to 100% (higher score means better performance).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
Changes in Canadian Occupational Performance Measure (COPM)
The COPM measures the patient's self-perception of occupational performance and satisfaction of it in daily activities over time. It ranges from 1 to 10 (higher score means better performance).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
Changes in Both Hands Assessment (BoHA)
The BoHA is a videotaped tool measuring how effectively children with bilateral CP use both hands in bimanual activities.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
Changes in Executive Functions
Cognitive functions of the children will be assessed by Stroop task and Flanker task.
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in spatial parameters of the gait (Kinematics assessments)
Through a 3D motion system, we measure the stride length (meters), step length (meters) and step width (meters).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the gait (Cycle time)
Through a 3D motion system, we measure the cycle of gait time (seconds).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the gait (Stance time)
Through a 3D motion system, we measure the stance time (percentage of the total gait cycle).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the gait (Swing time)
Through a 3D motion system, we measure the swing time (percentage of the total gait cycle).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the gait (Stride)
Through a 3D motion system, we measure the gait cadence (stride per minute).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the gait (Velocity)
Through a 3D motion system, we measure the gait velocity (meter/second).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the gait (Acceleration)
Through a 3D motion system, we measure the gait acceleration (meters/second^2).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in spatial parameters of the upper extremity (Straightness)
Through a 3D motion system, we measure the straightness (percentage of upper extremity trajectory during a reaching task).
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in spatial parameters of the upper extremity (Smoothness)
Through a 3D motion system, we measure the smoothness (variability of the movement during a reaching task)
Measured: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the upper extremity (Kinematics assessments)
Through a 3D motion system, we measure the time from onset to end of the task (seconds). the task consists in a reaching task.
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 posted27 May 2020
- Study start26 May 2020
- Primary completion20 Nov 2022 (estimated)
- Study completion20 Dec 2022 (estimated)
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
- 30 participants (estimated)
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
- Investigators
- Yannick Bleyenheuft, Professor, Principal investigator, Institute of Neuroscience, UCLouvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403464
- Sponsor's protocol ID
- B403201316810e
- Status last verified
- Jun 2022
- First submitted
- 20 May 2020
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kilcioglu S, Schiltz B, Carton de Tournai A, Herman E, Rosselli Z, Somville M, Ducoffre E, De Clerck C, Ebner-Karestinos D, Araneda R, Saussez G, Bleyenheuft Y. Efficacy of Integrating the Interactive Virtual Device (REAtouch(R)) into HABIT-ILE for Children with Bilateral Cerebral Palsy: A Randomized Controlled Non-Inferiority Trial. Neurorehabil Neural Repair. 2026 Aug 15:15459683261469065. doi: 10.1177/15459683261469065. Online ahead of print.
PubMed 42603855
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using a New Interactive Device Based on Motor Skill Learning Principles on the Motor and Functional Abilities of Children With Bilateral Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04403464
- Acronym / sponsor ID
- B403201316810e
- Conditions
- Cerebral Palsy
- Keywords
- motor skill learning, intensive therapy, selective voluntary motor control, cerebral palsy, assistive technology, therapeutic device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 26 May 2020 (actual)
- Primary completion
- 20 Nov 2022 (estimated)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 27 May 2020 (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.
Recent research has shown that interventions with assistive technologies lead to an improvement in the motor and functional abilities of children with cerebral palsy (CP). REAtouch® is a new interactive interface based on motor skill learning principles. Its efficiency during intensive motor skill learning interventions has never been tested in children with bilateral cerebral palsy.
Therefore, the study aims to investigate the efficiency of using a virtual reality tool to provide a motor skill learning intervention in a randomized trial.
Detailed description
Recent research has shown that interventions with assistive technologies could lead to an improvement in the motor and functional abilities of children with cerebral palsy (CP). However they usually miss the functional motor skill learning qualities to match the changes observed in high intensity motor skill learning based interventions.REAtouch® is a new interactive interface based on motor skill learning principles that could be implemented in intensive interventions.
Therefore, the study aims to investigate the effects of intensive interventions with or without the interface on the motor and functional abilities of children with bilateral CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HABIT-ILE with REAtouch® | Experimental | Behavioral: HABIT-ILE with REAtouch®Hand and Arm Bimanual Intensive Therapy Including Lower Extremities with an interactive device |
| HABIT-ILE without REAtouch® | Active comparator | Behavioral: HABIT-ILE without REAtouch®Hand and Arm Bimanual Intensive Therapy Including Lower Extremities |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosed bilateral cerebral palsy,
- MACS levels from I to III,
- GMFCS levels from I to III,
- Ability to follow instructions and complete testing.
Key exclusion criteria (3 listed)
- Orthopedic surgery, botulinum toxin injections or another unusual intervention less than 6 months before or within the study period.
- Unstable seizure
- Severe visual or cognitive impairments likely to interfere with intervention or testing session completion
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 with REAtouch®65h HABIT-ILE including 30h REAtouch® | Behavioural | HABIT-ILE with REAtouch® |
| HABIT-ILE without REAtouch®65h HABIT-ILE | Behavioural | HABIT-ILE without REAtouch® |
Primary outcome
Changes in Gross Motor Function Measure (GMFM-66):
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
The GMFM has been developed to measure the change in gross motor function over time in children with cerebral palsy.
Changes in ABILHAND-Kids Questionnaire
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
This ABILHAND-Kids Questionnaire has been developed to assess a child's unimanual and bimanual upper limb activities. It ranges from - 6 to +6 logits (higher score means better performance).
22 secondary outcomes
Changes in Test of Arm Selective Control (TASC)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
Changes in Selective Control Assessment of the Lower Extremity (SCALE)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
Changes in 6 Minutes Walking Test (6MWT)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
Changes in Box and Blocks test (BBT)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
Changes in Jebsen-Taylor Test
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
Changes in Modified Cooper test
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
Changes in ACTIVLIM-CP Questionnaire
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
Changes in ABILOCO-Kids Questionnaire
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
Changes in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
Changes in Canadian Occupational Performance Measure (COPM)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
Changes in Both Hands Assessment (BoHA)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
Changes in Executive Functions
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in spatial parameters of the gait (Kinematics assessments)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the gait (Cycle time)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the gait (Stance time)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the gait (Swing time)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the gait (Stride)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the gait (Velocity)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the gait (Acceleration)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in spatial parameters of the upper extremity (Straightness)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in spatial parameters of the upper extremity (Smoothness)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Changes in temporal parameters of the upper extremity (Kinematics assessments)
Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Derived from this study: PubMed 42603855Kilcioglu S, Schiltz B, Carton de Tournai A, Herman E, Rosselli Z, Somville M, Ducoffre E, De Clerck C, Ebner-Karestinos D, Araneda R, Saussez G, Bleyenheuft Y. Efficacy of Integrating the Interactive Virtual Device (REAtouch(R)) into HABIT-ILE for Children with Bilateral Cerebral Palsy: A Randomized Controlled Non-Inferiority Trial. Neurorehabil Neural Repair. 2026 Aug 15:15459683261469065. doi: 10.1177/15459683261469065. Online ahead of print.
- 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.
Seyma Kilcioglu, PhD Student contact
Yannick Bleyenheuft, Professor principal investigator
Institute of Neuroscience, UCLouvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HABIT-ILE with REAtouch® and HABIT-ILE without REAtouch® 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 4 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: status not confirmed, as of the sponsor's last update on 15 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yannick Bleyenheuft, Professor (+32 2 764 93 49, yannick.bleyenheuft@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Gross Motor Function Measure (GMFM-66): (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 NCT04403464, 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 15 Jun 2022.