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Published in: BMC Pediatrics 1/2018

Open Access 01-12-2018 | Study protocol

Combining constraint-induced movement therapy and action-observation training in children with unilateral cerebral palsy: a randomized controlled trial

Authors: Cristina Simon-Martinez, Lisa Mailleux, Els Ortibus, Anna Fehrenbach, Giuseppina Sgandurra, Giovanni Cioni, Kaat Desloovere, Nicole Wenderoth, Philippe Demaerel, Stefan Sunaert, Guy Molenaers, Hilde Feys, Katrijn Klingels

Published in: BMC Pediatrics | Issue 1/2018

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Abstract

Background

Upper limb (UL) deficits in children with unilateral cerebral palsy (uCP) have traditionally been targeted with motor execution treatment models, such as modified Constraint-Induced Movement Therapy (mCIMT). However, new approaches based on a neurophysiological model such as Action-Observation Training (AOT) may provide new opportunities for enhanced motor learning. The aim of this study is to describe a randomised controlled trial (RCT) protocol investigating the effects of an intensive treatment model, combining mCIMT and AOT compared to mCIMT alone on UL function in children with uCP. Additionally, the role of neurological factors as potential biomarkers of treatment response will be analysed.

Methods

An evaluator-blinded RCT will be conducted in 42 children aged between 6 and 12 years. Before randomization, children will be stratified according to their House Functional Classification Scale, age and type of corticospinal tract wiring. A 2-week day-camp will be set up in which children receive intensive mCIMT therapy for 6 hours a day on 9 out of 11 consecutive days (54 h) including AOT or control condition (15 h). During AOT, these children watch video sequences showing goal-directed actions and subsequently execute the observed actions with the more impaired UL. The control group performs the same actions after watching computer games without human motion. The primary outcome measure will be the Assisting Hand Assessment. Secondary outcomes comprise clinical assessments across body function, activity and participation level of the International Classification of Function, Disability and Health. Furthermore, to quantitatively evaluate UL movement patterns, a three-dimensional motion analysis will be conducted. UL function will be assessed at baseline, immediately before and after intervention and at 6 months follow up. Brain imaging comprising structural and functional connectivity measures as well as Transcranial Magnetic Stimulation (TMS) to evaluate corticospinal tract wiring will be acquired before the intervention.

Discussion

This paper describes the methodology of an RCT with two main objectives: (1) to evaluate the added value of AOT to mCIMT on UL outcome in children with uCP and (2) to investigate the role of neurological factors as potential biomarkers of treatment response.

Trial registration

NCT03256357 registered on 21st August 2017 (retrospectively registered).
Appendix
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Metadata
Title
Combining constraint-induced movement therapy and action-observation training in children with unilateral cerebral palsy: a randomized controlled trial
Authors
Cristina Simon-Martinez
Lisa Mailleux
Els Ortibus
Anna Fehrenbach
Giuseppina Sgandurra
Giovanni Cioni
Kaat Desloovere
Nicole Wenderoth
Philippe Demaerel
Stefan Sunaert
Guy Molenaers
Hilde Feys
Katrijn Klingels
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Pediatrics / Issue 1/2018
Electronic ISSN: 1471-2431
DOI
https://doi.org/10.1186/s12887-018-1228-2

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