Cerebral Palsychange_CPNCT02667613
Changes in Everydaylife Activity of Children With CP During HABIT-ILE
A study testing HABIT-ILE in people with Cerebral Palsy, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Studying in a RCT the changes in everyday llife activities of children with CP during HABIT-ILE or control period, changes being scored by parents and by experts. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2015to Dec 2019
- 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
- cerebral palsy
- ability to make a few steps with a walking device
- ability to pick a light object from a table with the more affected hand
- ability to understand simple games
Who cannot join
- no active seizure
- no botulinum toxin in the 6 months previous to the intervention or during intervention time
- major visual deficit
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: Effet de la réadaptation Sur Les déficiences, Limitations d'activité et Restriction de la Participation Des Enfants présentant Des lésions Neurologiques Non-évolutives. Part IIb
Studying in a RCT the changes in everyday llife activities of children with CP during HABIT-ILE or control period, changes being scored by parents and by experts.
Read the detailed description
Studying in a RCT the changes in everyday llife activities of children with CP (unilateral and bilateral) during HABIT-ILE or control period, changes being scored by parents and by experts on ABILHAND-Kids, the PEDI, the ACTIVLM-CP and the COPM. Investigate neuroplastic changes and correlation with everyday life changes.
- Conditions
- Cerebral Palsy
- Being tested
- HABIT-ILE, Control
- Keywords
- motor skill learning, functional changes, neuroplastic changes
- 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-ILEOther
Hand and arm bimanual intensive therapy including lower extremities
ControlOther
Usual customary care
| Study group | Role | What they receive |
|---|---|---|
| HABIT-ILE | Experimental | HABIT-ILE (Hand and arm bimanual intensive therapy including lower extremities) will be applied over 2 weeks. Receives: Other: HABIT-ILE |
| Control | Active comparator | A two weeks period of usual customary care. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in activity measure (questionnaires)
change in a measure of daily activities through ABILHAND-Kids, ACTIVLIM-CP and the COPM
Measured: 2 weeks of intervention and 4 months (follow-up)
Secondary outcomes (1)
neuroplastic changes in the cortex (MRI, fMRI, DTI, TMS)
measure of neuroplastic changes through TMS and MRI
Measured: baseline and 2 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 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
- Investigators
- Yannick Bleyenheuft, PhD, Principal investigator, Institute of Neuroscience, Université catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667613
- Sponsor's protocol ID
- B403201316810b
- Acronym
- change_CP
- Status last verified
- Dec 2020
- First submitted
- 21 Dec 2015
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Araneda R, Dricot L, Ebner-Karestinos D, Paradis J, Gordon AM, Friel KM, Bleyenheuft Y. Brain activation changes following motor training in children with unilateral cerebral palsy: An fMRI study. Ann Phys Rehabil Med. 2021 May;64(3):101502. doi: 10.1016/j.rehab.2021.101502. Epub 2021 Mar 22.
PubMed 33647530Bleyenheuft Y, Dricot L, Ebner-Karestinos D, Paradis J, Saussez G, Renders A, De Volder A, Araneda R, Gordon AM, Friel KM. Motor Skill Training May Restore Impaired Corticospinal Tract Fibers in Children With Cerebral Palsy. Neurorehabil Neural Repair. 2020 Jun;34(6):533-546. doi: 10.1177/1545968320918841. Epub 2020 May 14.
PubMed 32407247Paradis J, Dispa D, De Montpellier A, Ebner-Karestinos D, Araneda R, Saussez G, Renders A, Arnould C, Bleyenheuft Y. Interrater Reliability of Activity Questionnaires After an Intensive Motor-Skill Learning Intervention for Children With Cerebral Palsy. Arch Phys Med Rehabil. 2019 Sep;100(9):1655-1662. doi: 10.1016/j.apmr.2018.12.039. Epub 2019 Feb 18.
PubMed 30790557
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
- Effet de la réadaptation Sur Les déficiences, Limitations d'activité et Restriction de la Participation Des Enfants présentant Des lésions Neurologiques Non-évolutives. Part IIb
- ClinicalTrials.gov ID
- NCT02667613
- Acronym / sponsor ID
- change_CP / B403201316810b
- Conditions
- Cerebral Palsy
- Keywords
- motor skill learning, functional changes, neuroplastic changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 29 Jan 2016 (estimated)
- 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.
Studying in a RCT the changes in everyday llife activities of children with CP during HABIT-ILE or control period, changes being scored by parents and by experts.
Detailed description
Studying in a RCT the changes in everyday llife activities of children with CP (unilateral and bilateral) during HABIT-ILE or control period, changes being scored by parents and by experts on ABILHAND-Kids, the PEDI, the ACTIVLM-CP and the COPM. Investigate neuroplastic changes and correlation with everyday life changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HABIT-ILE | Experimental | Other: HABIT-ILEHABIT-ILE (Hand and arm bimanual intensive therapy including lower extremities) will be applied over 2 weeks. |
| Control | Active comparator | Other: ControlA two weeks period of usual customary care. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- cerebral palsy
- ability to make a few steps with a walking device
- ability to pick a light object from a table with the more affected hand
- ability to understand simple games
Key exclusion criteria (3 listed)
- no active seizure
- no botulinum toxin in the 6 months previous to the intervention or during intervention time
- major visual deficit
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-ILEHand and arm bimanual intensive therapy including lower extremities | Other | HABIT-ILE |
| ControlUsual customary care | Other | Control |
Primary outcome
Change in activity measure (questionnaires)
Time frame: 2 weeks of intervention and 4 months (follow-up)
change in a measure of daily activities through ABILHAND-Kids, ACTIVLIM-CP and the COPM
1 secondary outcome
neuroplastic changes in the cortex (MRI, fMRI, DTI, TMS)
Time frame: baseline and 2 weeks of intervention
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 33647530Araneda R, Dricot L, Ebner-Karestinos D, Paradis J, Gordon AM, Friel KM, Bleyenheuft Y. Brain activation changes following motor training in children with unilateral cerebral palsy: An fMRI study. Ann Phys Rehabil Med. 2021 May;64(3):101502. doi: 10.1016/j.rehab.2021.101502. Epub 2021 Mar 22.
- Derived from this study: PubMed 32407247Bleyenheuft Y, Dricot L, Ebner-Karestinos D, Paradis J, Saussez G, Renders A, De Volder A, Araneda R, Gordon AM, Friel KM. Motor Skill Training May Restore Impaired Corticospinal Tract Fibers in Children With Cerebral Palsy. Neurorehabil Neural Repair. 2020 Jun;34(6):533-546. doi: 10.1177/1545968320918841. Epub 2020 May 14.
- Derived from this study: PubMed 30790557Paradis J, Dispa D, De Montpellier A, Ebner-Karestinos D, Araneda R, Saussez G, Renders A, Arnould C, Bleyenheuft Y. Interrater Reliability of Activity Questionnaires After an Intensive Motor-Skill Learning Intervention for Children With Cerebral Palsy. Arch Phys Med Rehabil. 2019 Sep;100(9):1655-1662. doi: 10.1016/j.apmr.2018.12.039. Epub 2019 Feb 18.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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.
Yannick Bleyenheuft, PhD principal investigator
Institute of Neuroscience, Université catholique de Louvain
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 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: 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 in activity measure (questionnaires) (time frame: 2 weeks of intervention and 4 months (follow-up)). 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 NCT02667613, which also lists 3 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 21 Dec 2020.