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Serious game versus standard care for rehabilitation after distal radius fractures: a protocol for a multicentre randomised controlled trial

INTRODUCTION: Distal radius fractures are among the most prevalent traumatic injuries worldwide. These injuries are associated with high healthcare-related and socioeconomic costs, mainly resulting from loss of productivity. To optimise recovery and return to work, wrist exercises are recommended. H...

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Autores principales: Meijer, Henriëtte A W, Graafland, Maurits, Obdeijn, Miryam C, van Dieren, Susan, Goslings, J Carel, Schijven, Marlies P
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8030479/
https://www.ncbi.nlm.nih.gov/pubmed/33785488
http://dx.doi.org/10.1136/bmjopen-2020-042629
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author Meijer, Henriëtte A W
Graafland, Maurits
Obdeijn, Miryam C
van Dieren, Susan
Goslings, J Carel
Schijven, Marlies P
author_facet Meijer, Henriëtte A W
Graafland, Maurits
Obdeijn, Miryam C
van Dieren, Susan
Goslings, J Carel
Schijven, Marlies P
author_sort Meijer, Henriëtte A W
collection PubMed
description INTRODUCTION: Distal radius fractures are among the most prevalent traumatic injuries worldwide. These injuries are associated with high healthcare-related and socioeconomic costs, mainly resulting from loss of productivity. To optimise recovery and return to work, wrist exercises are recommended. However, adherence to standard exercise regimens is low. Serious games provide a treatment platform for standardised postoperative care, uniting meaningful recovery with entertainment. Also, mobile serious games, for example, smartphone or tablet applications, are able to send practice reminders believed to improve self-efficacy. METHODS AND ANALYSIS: To test the effectiveness of a mobile serious game for distal radius fracture rehabilitation compared with standard care, a multicentre, randomised controlled clinical trial was designed. Primary outcome will be the Patient-Rated Wrist Evaluation (PRWE) score after 6 weeks of treatment. Secondary outcomes are range of motion, grip strength, pain scores, and self-reported treatment adherence after 2, 6 and 12 weeks of treatment. Adult patients with any type of closed distal radius fracture are included directly after non-operative or operative fracture treatment. Patients are recruited in the outpatient clinics of four teaching hospitals. The intended sample size is 92 patients, based on the minimal clinically important difference of the PRWE score at 6 weeks, using a superiority model. Patients are randomised between using the wearable-controlled mobile serious game ReValidate! (intervention group) and standard care consisting of unsupervised exercises and a referral for physiotherapy or exercise therapy upon request or recommendation by the treating clinician (control group). ETHICS AND DISSEMINATION: The protocol has been approved by the Medical Ethical Review Board of the Amsterdam University Medical Centres, location Academic Medical Centre in Amsterdam, the Netherlands. Results will be made available to involved healthcare providers, funders, and to the general public including patients via peer-reviewed academic journals and international conferences. TRIAL REGISTRATION NUMBER: Dutch Trial Registry (NTR), NL6140, protocol V.2.
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spelling pubmed-80304792021-04-27 Serious game versus standard care for rehabilitation after distal radius fractures: a protocol for a multicentre randomised controlled trial Meijer, Henriëtte A W Graafland, Maurits Obdeijn, Miryam C van Dieren, Susan Goslings, J Carel Schijven, Marlies P BMJ Open Rehabilitation Medicine INTRODUCTION: Distal radius fractures are among the most prevalent traumatic injuries worldwide. These injuries are associated with high healthcare-related and socioeconomic costs, mainly resulting from loss of productivity. To optimise recovery and return to work, wrist exercises are recommended. However, adherence to standard exercise regimens is low. Serious games provide a treatment platform for standardised postoperative care, uniting meaningful recovery with entertainment. Also, mobile serious games, for example, smartphone or tablet applications, are able to send practice reminders believed to improve self-efficacy. METHODS AND ANALYSIS: To test the effectiveness of a mobile serious game for distal radius fracture rehabilitation compared with standard care, a multicentre, randomised controlled clinical trial was designed. Primary outcome will be the Patient-Rated Wrist Evaluation (PRWE) score after 6 weeks of treatment. Secondary outcomes are range of motion, grip strength, pain scores, and self-reported treatment adherence after 2, 6 and 12 weeks of treatment. Adult patients with any type of closed distal radius fracture are included directly after non-operative or operative fracture treatment. Patients are recruited in the outpatient clinics of four teaching hospitals. The intended sample size is 92 patients, based on the minimal clinically important difference of the PRWE score at 6 weeks, using a superiority model. Patients are randomised between using the wearable-controlled mobile serious game ReValidate! (intervention group) and standard care consisting of unsupervised exercises and a referral for physiotherapy or exercise therapy upon request or recommendation by the treating clinician (control group). ETHICS AND DISSEMINATION: The protocol has been approved by the Medical Ethical Review Board of the Amsterdam University Medical Centres, location Academic Medical Centre in Amsterdam, the Netherlands. Results will be made available to involved healthcare providers, funders, and to the general public including patients via peer-reviewed academic journals and international conferences. TRIAL REGISTRATION NUMBER: Dutch Trial Registry (NTR), NL6140, protocol V.2. BMJ Publishing Group 2021-03-30 /pmc/articles/PMC8030479/ /pubmed/33785488 http://dx.doi.org/10.1136/bmjopen-2020-042629 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle Rehabilitation Medicine
Meijer, Henriëtte A W
Graafland, Maurits
Obdeijn, Miryam C
van Dieren, Susan
Goslings, J Carel
Schijven, Marlies P
Serious game versus standard care for rehabilitation after distal radius fractures: a protocol for a multicentre randomised controlled trial
title Serious game versus standard care for rehabilitation after distal radius fractures: a protocol for a multicentre randomised controlled trial
title_full Serious game versus standard care for rehabilitation after distal radius fractures: a protocol for a multicentre randomised controlled trial
title_fullStr Serious game versus standard care for rehabilitation after distal radius fractures: a protocol for a multicentre randomised controlled trial
title_full_unstemmed Serious game versus standard care for rehabilitation after distal radius fractures: a protocol for a multicentre randomised controlled trial
title_short Serious game versus standard care for rehabilitation after distal radius fractures: a protocol for a multicentre randomised controlled trial
title_sort serious game versus standard care for rehabilitation after distal radius fractures: a protocol for a multicentre randomised controlled trial
topic Rehabilitation Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8030479/
https://www.ncbi.nlm.nih.gov/pubmed/33785488
http://dx.doi.org/10.1136/bmjopen-2020-042629
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