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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cerebral Palsy

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

External Links

•   lab web page