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

December 18, 2020 updated by: Yannick Bleyenheuft, Université Catholique de Louvain

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Institute of Neuroscience, Université catholique de Louvain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 weeks of intervention and 4 months (follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline and 2 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université Catholique de Louvain

Investigators

  • Principal Investigator: Yannick Bleyenheuft, PhD, Institute of Neuroscience, Université catholique de Louvain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

December 21, 2015

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Actual)

December 21, 2020

Last Update Submitted That Met QC Criteria

December 18, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B403201316810b

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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