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Completed

NCT Number: NCT02667613

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Neuroscience, Université catholique de Louvain

Brussels, 1200, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HABIT-ILE

Other

Hand and arm bimanual intensive therapy including lower extremities

Control

Other

Usual customary care

Primary outcomes

  1. 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

Secondary outcomes

  1. neuroplastic changes in the cortex (MRI, fMRI, DTI, TMS)

    Time frame: baseline and 2 weeks of intervention

    measure of neuroplastic changes through TMS and MRI

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Official study 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

Acronym: change_CP

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 29, 2016
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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