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

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
HABIT-ILE
Control
Sponsored by
Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring motor skill learning, functional changes, neuroplastic changes

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Neuroscience, Université catholique de Louvain

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HABIT-ILE

Control

Arm Description

HABIT-ILE (Hand and arm bimanual intensive therapy including lower extremities) will be applied over 2 weeks.

A two weeks period of usual customary care.

Outcomes

Primary Outcome Measures

Change in activity measure (questionnaires)
change in a measure of daily activities through ABILHAND-Kids, ACTIVLIM-CP and the COPM

Secondary Outcome Measures

neuroplastic changes in the cortex (MRI, fMRI, DTI, TMS)
measure of neuroplastic changes through TMS and MRI

Full Information

First Posted
December 21, 2015
Last Updated
December 18, 2020
Sponsor
Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT02667613
Brief Title
Changes in Everydaylife Activity of Children With CP During HABIT-ILE
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Catholique de Louvain

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
motor skill learning, functional changes, neuroplastic changes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HABIT-ILE
Arm Type
Experimental
Arm Description
HABIT-ILE (Hand and arm bimanual intensive therapy including lower extremities) will be applied over 2 weeks.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
A two weeks period of usual customary care.
Intervention Type
Other
Intervention Name(s)
HABIT-ILE
Intervention Description
Hand and arm bimanual intensive therapy including lower extremities
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Usual customary care
Primary Outcome Measure Information:
Title
Change in activity measure (questionnaires)
Description
change in a measure of daily activities through ABILHAND-Kids, ACTIVLIM-CP and the COPM
Time Frame
2 weeks of intervention and 4 months (follow-up)
Secondary Outcome Measure Information:
Title
neuroplastic changes in the cortex (MRI, fMRI, DTI, TMS)
Description
measure of neuroplastic changes through TMS and MRI
Time Frame
baseline and 2 weeks of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yannick Bleyenheuft, PhD
Organizational Affiliation
Institute of Neuroscience, Université catholique de Louvain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Neuroscience, Université catholique de Louvain
City
Brussels
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33647530
Citation
Araneda R, Dricot L, Ebner-Karestinos D, Paradis J, Gordon AM, Friel KM, Bleyenheuft Y. Brain activation changes following motor training in children with unilateral cerebral palsy: An fMRI study. Ann Phys Rehabil Med. 2021 May;64(3):101502. doi: 10.1016/j.rehab.2021.101502. Epub 2021 Mar 22.
Results Reference
derived
PubMed Identifier
32407247
Citation
Bleyenheuft Y, Dricot L, Ebner-Karestinos D, Paradis J, Saussez G, Renders A, De Volder A, Araneda R, Gordon AM, Friel KM. Motor Skill Training May Restore Impaired Corticospinal Tract Fibers in Children With Cerebral Palsy. Neurorehabil Neural Repair. 2020 Jun;34(6):533-546. doi: 10.1177/1545968320918841. Epub 2020 May 14.
Results Reference
derived
PubMed Identifier
30790557
Citation
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.
Results Reference
derived
Links:
URL
https://uclouvain.be/en/research-institutes/ions/cosy/motor-skill-learning-and-intensive-neurorehabilitation-lab-msl-in.html
Description
lab web page

Learn more about this trial

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

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