Can a pathological model improve the abilities of the paretic hand in hemiplegic children? The PAM-AOT study protocol of a randomised controlled trial

Introduction Action Observation Treatment (AOT) is an innovative therapeutic approach consisting in the observation of actions followed by subsequent repetition. In children with unilateral cerebral palsy (UCP), it improves upper limb function in daily activities. The standard paradigm of AOT requir...

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Main Authors: Stefania Costi, Silvio Cavuto, Adriano Ferrari, Jessica Verzelloni, Antonino Errante, Laura Beccani, Mariacristina Filippi, Barbara Bressi, Settimio Ziccarelli, Francesca Bozzetti, Elena Pineschi, Leonardo Fogassi
Format: Article
Language:English
Published: BMJ Publishing Group 2021-12-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/11/12/e053910.full
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author Stefania Costi
Silvio Cavuto
Adriano Ferrari
Jessica Verzelloni
Antonino Errante
Laura Beccani
Mariacristina Filippi
Barbara Bressi
Settimio Ziccarelli
Francesca Bozzetti
Elena Pineschi
Leonardo Fogassi
author_facet Stefania Costi
Silvio Cavuto
Adriano Ferrari
Jessica Verzelloni
Antonino Errante
Laura Beccani
Mariacristina Filippi
Barbara Bressi
Settimio Ziccarelli
Francesca Bozzetti
Elena Pineschi
Leonardo Fogassi
author_sort Stefania Costi
collection DOAJ
description Introduction Action Observation Treatment (AOT) is an innovative therapeutic approach consisting in the observation of actions followed by subsequent repetition. In children with unilateral cerebral palsy (UCP), it improves upper limb function in daily activities. The standard paradigm of AOT requires the observation of healthy models; however, it has been demonstrated that the mirror neuron system of children with UCP is more activated by observation of pathological models, showing a similar motor repertoire, than by the healthy model, suggesting that AOT based on pathological models is superior to the standard paradigm of AOT in the functional rehabilitation of the affected upper limb of children with UCP.Methods and analysis This protocol describes an active two-arm randomised controlled evaluator-blinded trial. Twenty-six children with UCP will participate in 3 weeks of intensive AOT: the experimental group will observe a pathological model, while the control group will observe a typically developed model. The primary outcome is the spontaneous use of the paretic hand, measured with the Assisting Hand Assessment. Secondary outcome measures are the Melbourne Assessment of Unilateral Upper Limb Function, the ABILHAND-Kids and the Activities Scale for Kids-performance. Assessments will be performed at baseline (T0), at the end of intensive AOT (T1), at 8–12 weeks (T2) and at 24–28 weeks (T3) after the end of intensive AOT.Ethics and dissemination The trial was approved by the Area Vasta Emilia Nord Ethics Committee (AVEN prot. n. 133117, 29 November 2018), and it was prospectively registered on ClinicalTrials.gov. The results will be submitted for publication to a peer-reviewed journal, discussed with parents of children participating in the trial and disseminated at suitable conferences.Trial registration number NCT04088994; Pre-results.
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spelling doaj-art-2a6cf0860ff0497ba91e319a7610786a2024-12-10T16:55:08ZengBMJ Publishing GroupBMJ Open2044-60552021-12-01111210.1136/bmjopen-2021-053910Can a pathological model improve the abilities of the paretic hand in hemiplegic children? The PAM-AOT study protocol of a randomised controlled trialStefania Costi0Silvio Cavuto1Adriano Ferrari2Jessica Verzelloni3Antonino Errante4Laura Beccani5Mariacristina Filippi6Barbara Bressi7Settimio Ziccarelli8Francesca Bozzetti9Elena Pineschi10Leonardo Fogassi11University of Modena and Reggio Emilia, Modena, Italy2 Clinical Trials and Statistics Unit, Azienda USL-IRCCS of Reggio Emilia, via Amendola, Reggio Emilia, ItalyUnità per le gravi disabilità dell`età evolutiva, Azienda USL—IRCCS di Reggio Emilia, Reggio Emilia, Emilia-Romagna, ItalyDepartment of Surgery, Medicine, Dentistry and Morphological Sciences, University of Modena and Reggio Emilia, Modena, Emilia-Romagna, ItalyDepartment of Medicine and Surgery, University of Parma, Parma, Emilia-Romagna, ItalyUnità per le gravi disabilità dell`età evolutiva, Azienda USL—IRCCS di Reggio Emilia, Reggio Emilia, Emilia-Romagna, ItalyUnità per le gravi disabilità dell`età evolutiva, Azienda USL—IRCCS di Reggio Emilia, Reggio Emilia, Emilia-Romagna, ItalyDepartment of Neuromotor Physiopathology and Rehabilitation Medicine, Physical Medicine and Rehabilitation Unit, Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia, Reggio Emilia, ItalyDepartment of Medicine and Surgery, University of Parma, Parma, Emilia-Romagna, ItalyNeuroradiology Unit, University Hospital of Parma, Parma, Emilia-Romagna, ItalyUnità per le gravi disabilità dell`età evolutiva, Azienda USL—IRCCS di Reggio Emilia, Reggio Emilia, Emilia-Romagna, ItalyDepartment of Medicine and Surgery, University of Parma, Parma, Emilia-Romagna, ItalyIntroduction Action Observation Treatment (AOT) is an innovative therapeutic approach consisting in the observation of actions followed by subsequent repetition. In children with unilateral cerebral palsy (UCP), it improves upper limb function in daily activities. The standard paradigm of AOT requires the observation of healthy models; however, it has been demonstrated that the mirror neuron system of children with UCP is more activated by observation of pathological models, showing a similar motor repertoire, than by the healthy model, suggesting that AOT based on pathological models is superior to the standard paradigm of AOT in the functional rehabilitation of the affected upper limb of children with UCP.Methods and analysis This protocol describes an active two-arm randomised controlled evaluator-blinded trial. Twenty-six children with UCP will participate in 3 weeks of intensive AOT: the experimental group will observe a pathological model, while the control group will observe a typically developed model. The primary outcome is the spontaneous use of the paretic hand, measured with the Assisting Hand Assessment. Secondary outcome measures are the Melbourne Assessment of Unilateral Upper Limb Function, the ABILHAND-Kids and the Activities Scale for Kids-performance. Assessments will be performed at baseline (T0), at the end of intensive AOT (T1), at 8–12 weeks (T2) and at 24–28 weeks (T3) after the end of intensive AOT.Ethics and dissemination The trial was approved by the Area Vasta Emilia Nord Ethics Committee (AVEN prot. n. 133117, 29 November 2018), and it was prospectively registered on ClinicalTrials.gov. The results will be submitted for publication to a peer-reviewed journal, discussed with parents of children participating in the trial and disseminated at suitable conferences.Trial registration number NCT04088994; Pre-results.https://bmjopen.bmj.com/content/11/12/e053910.full
spellingShingle Stefania Costi
Silvio Cavuto
Adriano Ferrari
Jessica Verzelloni
Antonino Errante
Laura Beccani
Mariacristina Filippi
Barbara Bressi
Settimio Ziccarelli
Francesca Bozzetti
Elena Pineschi
Leonardo Fogassi
Can a pathological model improve the abilities of the paretic hand in hemiplegic children? The PAM-AOT study protocol of a randomised controlled trial
BMJ Open
title Can a pathological model improve the abilities of the paretic hand in hemiplegic children? The PAM-AOT study protocol of a randomised controlled trial
title_full Can a pathological model improve the abilities of the paretic hand in hemiplegic children? The PAM-AOT study protocol of a randomised controlled trial
title_fullStr Can a pathological model improve the abilities of the paretic hand in hemiplegic children? The PAM-AOT study protocol of a randomised controlled trial
title_full_unstemmed Can a pathological model improve the abilities of the paretic hand in hemiplegic children? The PAM-AOT study protocol of a randomised controlled trial
title_short Can a pathological model improve the abilities of the paretic hand in hemiplegic children? The PAM-AOT study protocol of a randomised controlled trial
title_sort can a pathological model improve the abilities of the paretic hand in hemiplegic children the pam aot study protocol of a randomised controlled trial
url https://bmjopen.bmj.com/content/11/12/e053910.full
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