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

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ClinicalTrials.gov Identifier: NCT02667613
Recruitment Status : Recruiting
First Posted : January 29, 2016
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Yannick Bleyenheuft, 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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: HABIT-ILE Other: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: HABIT-ILE
HABIT-ILE (Hand and arm bimanual intensive therapy including lower extremities) will be applied over 2 weeks.
Other: HABIT-ILE
Hand and arm bimanual intensive therapy including lower extremities

Active Comparator: Control
A two weeks period of usual customary care.
Other: Control
Usual customary care




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02667613


Contacts
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Contact: Yannick Bleyenheuft, PhD yannick.bleyenheuft@uclouvain.be
Contact: Julie Paradis, OT julie.paradis@uclouvain.be

Locations
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Belgium
Institute of Neuroscience, Université catholique de Louvain Recruiting
Brussels, Belgium, 1200
Contact: Yannick Bleyenheuft, PhD       yannick.bleyenheuft@uclouvain.be   
Contact: Julie Paradis, OT       julie.paradis@uclouvain.be   
Sponsors and Collaborators
Université Catholique de Louvain
Investigators
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Principal Investigator: Yannick Bleyenheuft, PhD Institute of Neuroscience, Université catholique de Louvain

Additional Information:
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Responsible Party: Yannick Bleyenheuft, Professor, Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT02667613     History of Changes
Other Study ID Numbers: B403201316810b
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Yannick Bleyenheuft, Université Catholique de Louvain:
motor skill learning
functional changes
neuroplastic changes

Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases