Tele-UPCAT: study protocol of a randomised controlled trial of a home-based Tele-monitored UPper limb Children Action observation Training for participants with unilateral cerebral palsy

Giuseppina Sgandurra, Francesca Cecchi, Elena Beani, Irene Mannari, Martina Maselli, Francesco Paolo Falotico, Emanuela Inguaggiato, Silvia Perazza, Elisa Sicola, Hilde Feys, Katrijn Klingels, Adriano Ferrari, Paolo Dario, Roslyn N Boyd, Giovanni Cioni

Research output: Contribution to journalArticle

Abstract

INTRODUCTION: A new rehabilitative approach, called UPper Limb Children Action Observation Training (UPCAT), based on the principles of action observation training (AOT), has provided promising results for upper limb rehabilitation in children with unilateral cerebral palsy (UCP). This study will investigate if a new information and communication technology platform, named Tele-UPCAT, is able to deliver AOT in a home setting and will test its efficacy on children and young people with UCP.

METHODS AND ANALYSIS: A randomised, allocation concealed (waitlist control) and evaluator-blinded clinical trial with two investigative arms will be carried out. The experimental group will perform AOT at home for 3 weeks using a customised Tele-UPCAT system where they will watch video sequences of goal-directed actions and then complete the motor training of the same actions. The control group will receive usual care for 3 weeks, which may include upper limb training. They will be offered AOT at home after 3 weeks. Twenty-four children with UCP will be recruited for 12 participants per group. The primary outcome will be measured using Assisting Hand Assessment. The Melbourne Assessment 2, ABILHAND, Participation and Environment Measure-Children and Youth and Cerebral Palsy Quality of Life Questionnaire will be included as secondary measures. Quantitative measures from sensorised objects and participants worn Actigraphs GXT3+ will be analysed. The assessment points will be the week before (T0) and after (T1) the period of AOT/standard care. Further assessments will be at T1 plus, the week after the AOT period for the waitlist group and at 8 weeks (T2) and 24 weeks (T3) after AOT training.

ETHICS AND DISSEMINATION: The trial has been approved by the Tuscany Paediatric Ethics Committee (169/2016). Publication of all outcomes will be in peer-reviewed journals and conference presentations.

TRIAL REGISTRATION: NCT03094455.

Original languageEnglish
Pages (from-to)e017819
JournalBMJ Open
Volume8
Issue number5
DOIs
Publication statusPublished - May 14 2018

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Cerebral Palsy
Upper Extremity
Randomized Controlled Trials
Observation
Ethics Committees
Publications
Arm
Rehabilitation
Hand
Communication
Quality of Life
Clinical Trials
Pediatrics
Technology
Control Groups

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Tele-UPCAT : study protocol of a randomised controlled trial of a home-based Tele-monitored UPper limb Children Action observation Training for participants with unilateral cerebral palsy. / Sgandurra, Giuseppina; Cecchi, Francesca; Beani, Elena; Mannari, Irene; Maselli, Martina; Falotico, Francesco Paolo; Inguaggiato, Emanuela; Perazza, Silvia; Sicola, Elisa; Feys, Hilde; Klingels, Katrijn; Ferrari, Adriano; Dario, Paolo; Boyd, Roslyn N; Cioni, Giovanni.

In: BMJ Open, Vol. 8, No. 5, 14.05.2018, p. e017819.

Research output: Contribution to journalArticle

Sgandurra, Giuseppina ; Cecchi, Francesca ; Beani, Elena ; Mannari, Irene ; Maselli, Martina ; Falotico, Francesco Paolo ; Inguaggiato, Emanuela ; Perazza, Silvia ; Sicola, Elisa ; Feys, Hilde ; Klingels, Katrijn ; Ferrari, Adriano ; Dario, Paolo ; Boyd, Roslyn N ; Cioni, Giovanni. / Tele-UPCAT : study protocol of a randomised controlled trial of a home-based Tele-monitored UPper limb Children Action observation Training for participants with unilateral cerebral palsy. In: BMJ Open. 2018 ; Vol. 8, No. 5. pp. e017819.
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abstract = "INTRODUCTION: A new rehabilitative approach, called UPper Limb Children Action Observation Training (UPCAT), based on the principles of action observation training (AOT), has provided promising results for upper limb rehabilitation in children with unilateral cerebral palsy (UCP). This study will investigate if a new information and communication technology platform, named Tele-UPCAT, is able to deliver AOT in a home setting and will test its efficacy on children and young people with UCP.METHODS AND ANALYSIS: A randomised, allocation concealed (waitlist control) and evaluator-blinded clinical trial with two investigative arms will be carried out. The experimental group will perform AOT at home for 3 weeks using a customised Tele-UPCAT system where they will watch video sequences of goal-directed actions and then complete the motor training of the same actions. The control group will receive usual care for 3 weeks, which may include upper limb training. They will be offered AOT at home after 3 weeks. Twenty-four children with UCP will be recruited for 12 participants per group. The primary outcome will be measured using Assisting Hand Assessment. The Melbourne Assessment 2, ABILHAND, Participation and Environment Measure-Children and Youth and Cerebral Palsy Quality of Life Questionnaire will be included as secondary measures. Quantitative measures from sensorised objects and participants worn Actigraphs GXT3+ will be analysed. The assessment points will be the week before (T0) and after (T1) the period of AOT/standard care. Further assessments will be at T1 plus, the week after the AOT period for the waitlist group and at 8 weeks (T2) and 24 weeks (T3) after AOT training.ETHICS AND DISSEMINATION: The trial has been approved by the Tuscany Paediatric Ethics Committee (169/2016). Publication of all outcomes will be in peer-reviewed journals and conference presentations.TRIAL REGISTRATION: NCT03094455.",
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AU - Sgandurra, Giuseppina

AU - Cecchi, Francesca

AU - Beani, Elena

AU - Mannari, Irene

AU - Maselli, Martina

AU - Falotico, Francesco Paolo

AU - Inguaggiato, Emanuela

AU - Perazza, Silvia

AU - Sicola, Elisa

AU - Feys, Hilde

AU - Klingels, Katrijn

AU - Ferrari, Adriano

AU - Dario, Paolo

AU - Boyd, Roslyn N

AU - Cioni, Giovanni

N1 - © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

PY - 2018/5/14

Y1 - 2018/5/14

N2 - INTRODUCTION: A new rehabilitative approach, called UPper Limb Children Action Observation Training (UPCAT), based on the principles of action observation training (AOT), has provided promising results for upper limb rehabilitation in children with unilateral cerebral palsy (UCP). This study will investigate if a new information and communication technology platform, named Tele-UPCAT, is able to deliver AOT in a home setting and will test its efficacy on children and young people with UCP.METHODS AND ANALYSIS: A randomised, allocation concealed (waitlist control) and evaluator-blinded clinical trial with two investigative arms will be carried out. The experimental group will perform AOT at home for 3 weeks using a customised Tele-UPCAT system where they will watch video sequences of goal-directed actions and then complete the motor training of the same actions. The control group will receive usual care for 3 weeks, which may include upper limb training. They will be offered AOT at home after 3 weeks. Twenty-four children with UCP will be recruited for 12 participants per group. The primary outcome will be measured using Assisting Hand Assessment. The Melbourne Assessment 2, ABILHAND, Participation and Environment Measure-Children and Youth and Cerebral Palsy Quality of Life Questionnaire will be included as secondary measures. Quantitative measures from sensorised objects and participants worn Actigraphs GXT3+ will be analysed. The assessment points will be the week before (T0) and after (T1) the period of AOT/standard care. Further assessments will be at T1 plus, the week after the AOT period for the waitlist group and at 8 weeks (T2) and 24 weeks (T3) after AOT training.ETHICS AND DISSEMINATION: The trial has been approved by the Tuscany Paediatric Ethics Committee (169/2016). Publication of all outcomes will be in peer-reviewed journals and conference presentations.TRIAL REGISTRATION: NCT03094455.

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