Digitally Assisted Versus Conventional Home-Based Rehabilitation After Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial

Fernando Dias Correia, Maria Molinos, Sara Luís, Diana Carvalho, Carlos Carvalho, Pedro Costa, Rosmaninho Seabra, Gerard Francisco, Virgílio Bento, Jorge Lains, Fernando Dias Correia, Maria Molinos, Sara Luís, Diana Carvalho, Carlos Carvalho, Pedro Costa, Rosmaninho Seabra, Gerard Francisco, Virgílio Bento, Jorge Lains

Abstract

Objective: The aim of this study was to evaluate the clinical impact of a 12-wk home-based digitally assisted rehabilitation program after arthroscopic rotator cuff repair against conventional home-based rehabilitation.

Design: The digital therapy group performed independent technology-assisted sessions complemented with 13 face-to-face sessions, and the conventional therapy group had conventional face-to-face physical therapy (30 sessions). Primary outcome was functional change between baseline and 12 wks, measured through the Constant-Murley score. Secondary outcomes were the change in the QuickDASH Scale and shoulder range of motion.

Results: Fifty participants enrolled; 41 completed the 12-wk program (23 digital therapy group vs. 18 conventional therapy group), and 32 (15 vs. 17) were available for the 12-mo follow-up assessment. No differences were found between groups regarding study endpoints at the end of the 12-wk program. However, follow-up results revealed the superiority of the digital therapy group for QuickDASH (P = 0.043), as well as an interaction between time and group in the Constant-Murley score (P = 0.047) in favor of the digital therapy group.

Conclusions: The results demonstrate that digital therapeutics can be used to achieve similar, if not superior, short- and long-term outcomes as conventional approaches after arthroscopic rotator cuff repair, while being far less human resource intensive than conventional care.Level of evidence: II.

Trial registration: ClinicalTrials.gov NCT03648047.

Conflict of interest statement

MM, SL, DC, CC, and PC are employees at SWORD Health. FDC is the Chief Medical Officer of SWORD Health and owns stock in the company. JL and GF received a scientific councilor honorarium from SWORD Health. VB is the Chief Executive Officer of SWORD Health and owns stock in the company. RS declares that he has no conflict of interest.

Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.

Figures

FIGURE 1
FIGURE 1
Digital therapy system components. A, Motion tracker setup. B, Mobile app: preparation screen (bottom image)—this screen is shown before each exercise and displays a video of the exercise, as well as audio instructions, and execution screen (top image)—this screen is shown during exercise execution, giving real-time audiovisual feedback on exercise performance. C, Web portal: results screen (bottom) and exercise prescription screen (top), for patient’s remote management by the PT.
FIGURE 2
FIGURE 2
Study CONSORT diagram.
FIGURE 3
FIGURE 3
Evolution of the clinical outcomes over time in both groups, based on the repeated-measures analysis (estimated marginal means of transformed variables are presented). A, Constant-Murley shoulder outcome score. B, QuickDASH. C, Shoulder SE. D, Shoulder F. E, Shoulder A. F, Shoulder ER.

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