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

NCT02667613 | Completed

• 1 other identifier: B403201316810b
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

motor skill learning; functional changes; neuroplastic changes

Outcome Measures

Primary Outcomes (1)

• Change in activity measure (questionnaires)

  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 Outcomes (1)

• neuroplastic changes in the cortex (MRI, fMRI, DTI, TMS)

  baseline and 2 weeks of intervention

Study Arms (2)

HABIT-ILE

EXPERIMENTAL

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

Other: HABIT-ILE

Control

ACTIVE COMPARATOR

A two weeks period of usual customary care.

Other: Control

Interventions

HABIT-ILE OTHER

Hand and arm bimanual intensive therapy including lower extremities

HABIT-ILE

Control OTHER

Usual customary care

Control

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• no active seizure
• no botulinum toxin in the 6 months previous to the intervention or during intervention time
• major visual deficit

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

Institute of Neuroscience, Université catholique de Louvain

Brussels, 1200, Belgium

Location

Related Publications (3)

• 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.

  PMID: 33647530 DERIVED

• 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.

  PMID: 32407247 DERIVED

• 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.

  PMID: 30790557 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Yannick Bleyenheuft, PhD

  Institute of Neuroscience, Université catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: January 29, 2016
• Study Start: June 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)