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

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.

Keywords: action observation training; information and communication technologies; randomized controlled trial; tele-rehabilitation; unilateral cerebral palsy; upper limb.

Conflict of interest statement

Competing interests: None declared.

© 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.

Figures

Figure 1

Flow chart of Tele-UPCAT study according to CONSORT guidelines. AHA, Assisting Hand Assessment; AOT, action observation training; BBT, Box and Block Test; CP-QOL, Cerebral Palsy Quality of Life; CONSORT, Consolidated Standards of Reporting Trials; MA 2, Melbourne Assessment 2; PEM-CY, Participation and Environment Measure – Children and Youth.

Figure 2

Schedule of enrolment, interventions and assessments. AHA, Assisting Hand Assessment; AOT, action observation training; BBT, Box and Block Test; CP-QOL, Cerebral Palsy Quality of Life Questionnaire; MA 2, Melbourne Assessment 2.

Figure 3

Tele-UPCAT platform. Set-up of the Tele-UPCAT platform for delivering the AOT at home. It includes an observation module for the presentation of AOT videos (1) selected in the clinical interface (2) by the clinical staff in relation to HFCS level (6–8, 4–5 or 2–3), side of impaired hand and type of interface. A dedicated software, aimed at guiding and motivating subjects to perform AOT, is also provided with age-related features (3) for teenagers or little boys and girls. The motor performance module for the execution of actions is composed of a kit of common objects and toys, identical to those shown in the videos and a couple of Actigraphs (wGT3X-BT and wActiSleep-BT) worn on both wrists and a button. The integrated camera records subject’s attention during the observation task and exercise execution. AOT, action observation training; HFCS, House functional classification system.

Figure 4

(A) Example of the unimanual action B of day 1 for the left hand, with a different pattern of movement, based on subject HFCS level, maintaining the same goal. (B) Example of the bimanual action B of day 11 for the right hand, with a different pattern of movement, based on subject HFCS level, maintaining the same goal. HFCS, House functional classification system.