TY - JOUR
T1 - Serious game versus standard care for rehabilitation after distal radius fractures: A protocol for a multicentre randomised controlled trial
AU - Meijer, Henriëtte A. W.
AU - Graafland, Maurits
AU - Obdeijn, Miryam C.
AU - van Dieren, Susan
AU - Goslings, J. Carel
AU - Schijven, Marlies P.
N1 - Funding Information: Funding The ReValidate! project received funding from the Growing Games Program (Dutch Game Garden, iMMovator, Dutch Games Association and the Economic Board Utrecht), grant number CB00018, and by a grant from the CZ Fund, the Netherlands. Disclaimer The sponsor had no role of any sort in the study design. Competing interests None declared. Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details. Publisher Copyright: © Author(s) 2021.
PY - 2021/3/30
Y1 - 2021/3/30
N2 - 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.
AB - 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.
KW - biotechnology & bioinformatics
KW - hand & wrist
KW - information technology
KW - orthopaedic & trauma surgery
KW - rehabilitation medicine
KW - telemedicine
UR - http://www.scopus.com/inward/record.url?scp=85103522412&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/bmjopen-2020-042629
DO - https://doi.org/10.1136/bmjopen-2020-042629
M3 - Article
C2 - 33785488
SN - 2044-6055
VL - 11
JO - BMJ Open
JF - BMJ Open
IS - 3
M1 - e042629
ER -