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

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Other: HABIT-ILE; Other: Control

• Registration Number: NCT02667613
• Lead Sponsor: Université Catholique de Louvain

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-12-21
• Study First Submitted QC: 2016-01-28
• Study First Posted: 2016-01-29
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-18
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HABIT-ILE	HABIT-ILE	HABIT-ILE (Hand and arm bimanual intensive therapy including lower extremities) will be applied over 2 weeks.
Control	Control	A two weeks period of usual customary care.

Primary Outcome Measures

Name	Time	Method
Change in activity measure (questionnaires)	2 weeks of intervention and 4 months (follow-up)	change in a measure of daily activities through ABILHAND-Kids, ACTIVLIM-CP and the COPM

Secondary Outcome Measures

Name	Time	Method
neuroplastic changes in the cortex (MRI, fMRI, DTI, TMS)	baseline and 2 weeks of intervention	measure of neuroplastic changes through TMS and MRI

Trial Locations

Locations (1)

Institute of Neuroscience, Université catholique de Louvain; 🇧🇪 Brussels, Belgium