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NCT02667613 Clinical Trial

Changes in Everydaylife Activity of Children With CP During HABIT-ILE

Cerebral Palsy Clinical Trial

— change_CP  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02667613
Other study ID # B403201316810b
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2015
Est. completion date December 2019

Study information
Verified date December 2020
Source Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 5 Years to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• HABIT-ILE
Hand and arm bimanual intensive therapy including lower extremities
• Control
Usual customary care

Locations
Country Name City State
Belgium Institute of Neuroscience, Université catholique de Louvain Brussels

Sponsors (1)
Lead Sponsor Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in activity measure (questionnaires) change in a measure of daily activities through ABILHAND-Kids, ACTIVLIM-CP and the COPM 2 weeks of intervention and 4 months (follow-up)
Secondary neuroplastic changes in the cortex (MRI, fMRI, DTI, TMS) measure of neuroplastic changes through TMS and MRI baseline and 2 weeks of intervention
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