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

NCT ID: NCT02667613

Last Updated: 2020-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Cerebral Palsy

Keywords

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motor skill learning functional changes neuroplastic changes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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HABIT-ILE

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

Group Type EXPERIMENTAL

HABIT-ILE

Intervention Type OTHER

Hand and arm bimanual intensive therapy including lower extremities

Control

A two weeks period of usual customary care.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Usual customary care

Interventions

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HABIT-ILE

Hand and arm bimanual intensive therapy including lower extremities

Intervention Type OTHER

Control

Usual customary care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Yannick Bleyenheuft

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yannick Bleyenheuft, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Neuroscience, Université catholique de Louvain

Locations

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Institute of Neuroscience, Université catholique de Louvain

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 33647530 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32407247 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30790557 (View on PubMed)

Other Identifiers

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B403201316810b

Identifier Type: -

Identifier Source: org_study_id