Clinical trial NCT02667613: Changes in Everydaylife Activity of Children With CP During HABIT-ILE
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: motor skill learning
functional changes
neuroplastic changes
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* no active seizure
* no botulinum toxin in the 6 months previous to the intervention or during intervention time
* major visual deficit

Primary outcomes:
measure: Change in activity measure (questionnaires)
timeFrame: 2 weeks of intervention and 4 months (follow-up)
Secondary outcomes:
measure: neuroplastic changes in the cortex (MRI, fMRI, DTI, TMS)
timeFrame: baseline and 2 weeks of intervention
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institute of Neuroscience, Université catholique de Louvain
Study officials:
affiliation: Institute of Neuroscience, Université catholique de Louvain
name: Yannick Bleyenheuft, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Bleyenheuft 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.
citation: Paradis 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.