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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

Tracking Information
First Submitted Date  ICMJE December 21, 2015
First Posted Date  ICMJE January 29, 2016
Last Update Posted Date April 29, 2019
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2016)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Changes in Everydaylife Activity of Children With CP During HABIT-ILE
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Palsy
Intervention  ICMJE
  • Other: HABIT-ILE
    Hand and arm bimanual intensive therapy including lower extremities
  • Other: Control
    Usual customary care
Study Arms  ICMJE
  • Experimental: HABIT-ILE
    HABIT-ILE (Hand and arm bimanual intensive therapy including lower extremities) will be applied over 2 weeks.
    Intervention: Other: HABIT-ILE
  • Active Comparator: Control
    A two weeks period of usual customary care.
    Intervention: Other: Control
Publications * Paradis J, Dispa D, De Montpellier A, Ebner-Karestinos D, Araneda R, Saussez G, Renders A, Arnould C, Bleyenheuft Y. Interrater Reliability of Activity Questionnaires After an Intensive Motor-Skill Learning Intervention for Children With Cerebral Palsy. Arch Phys Med Rehabil. 2019 Sep;100(9):1655-1662. doi: 10.1016/j.apmr.2018.12.039. Epub 2019 Feb 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 28, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yannick Bleyenheuft, PhD yannick.bleyenheuft@uclouvain.be
Contact: Julie Paradis, OT julie.paradis@uclouvain.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02667613
Other Study ID Numbers  ICMJE B403201316810b
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yannick Bleyenheuft, Université Catholique de Louvain
Study Sponsor  ICMJE Université Catholique de Louvain
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yannick Bleyenheuft, PhD Institute of Neuroscience, Université catholique de Louvain
PRS Account Université Catholique de Louvain
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP