AGT-Reha-WK study: protocol for a non-inferiority trial comparing the efficacy and costs of home-based telerehabilitation for shoulder diseases with medical exercise therapy

Abstract

IntroductionShoulder lesions rank among the top 15 diagnoses accounting for days of incapacity to work. Inpatient or full-day outpatient rehabilitation are some of the standard therapies. For sustainable rehabilitation, continuation of rehabilitation after discharge from a rehabilitation centre is vital. Besides medical exercise therapy (MET), home-based physical exercise programmes are used. To monitor exercise quantity and quality, AGT-Reha, a health-enabling technology for home rehabilitation, has been developed and evaluated in a pilot study for technical feasibility and acceptance. To integrate the digital therapeutic AGT-Reha into regular healthcare processes, an efficacy evaluation is required.Methods and analysisAGT-Reha-WK is a prospective, monocentric, non-randomised, unblinded non-inferiority trial. Primary objective is to investigate whether AGT-Reha enhanced home-based exercise training is non-inferior to MET as standard aftercare. Secondary objective is to compare the costs of both therapies. Efficacy as medical success (primary outcome) is examined with regard to ability to work, return to work and sustainability of training (secondary outcomes). The outcome measure for non-inferiority is shoulder function (pain and disability) assessed by the standardised Shoulder Pain and Disability Index (SPADI). The non-inferiority margin is set to 10 points on SPADI score using a 95% CI. Subjects will be recruited at the Rehabilitation Center Bad Pyrmont, Germany. The total number of subjects should be 84 (42 per group). Treatment takes 6 months per patient. Subjects will be assessed at four time points: pre-baseline (admission to rehabilitation centre), baseline (discharge from rehabilitation centre), post-therapy and follow-up (3 months post-therapy).Ethics and disseminationEthics approval was granted by the Ethics Committee of Hannover Medical School (ethics approval no: 7313). Results of the trial are planned to be published in a peer-reviewed journal.Trial registration numberGerman Clinical Trials Register DRKS00011596. Registered 2 June 2017. Recruitment started on 3 March 2017, and it is expected to continue until December 2020.Protocol versionV2.0, 23 May 2018, Amendment 01: improved risk analysis, clarification of exclusion criteria to increase reproducibility, additional documentation with OpenClinica; these changes have no effect on structural equality.

The Future of Artificial Intelligence in Sports Medicine and Return to Play

“…42 Adherence to the rehabilitation protocol is one of the biggest factors in a positive recovery; monitoring patient progress with wearable technology during home-based rehabilitation has been shown to promote adherence and have similar outcomes to in-clinic rehabilitation. [43][44][45]…”

Home-Based Rehabilitation of the Shoulder Using Auxiliary Systems and Artificial Intelligence: An Overview

“…The outcomes of wearable applications in home-based shoulder rehabilitation have been predominantly positive, ensuring patient safety and yielding rehabilitation results comparable to those observed in a care unit [ 51 , 55 ]. For instance, Condino et al [ 43 ] successfully tested these approaches with a group of five rehabilitation specialists and twenty healthy subjects, demonstrating the ergonomic design and motivational value of these interventions, which added positive value to the rehabilitation process.…”

“…Case studies and observational studies, on the other hand, involve observing and documenting the experiences of individual patients or groups of patients using auxiliary technologies [ 55 , 87 ]. These studies can provide valuable insights into the real-world use and effectiveness of these technologies.…”

Advanced Home-Based Shoulder Rehabilitation: A Systematic Review of Remote Monitoring Devices and Their Therapeutic Efficacy

“…The shoulder joint is essential to activities of daily living (ADLs), facilitating fundamental needs like eating, dressing, and personal hygiene [1]. Shoulder pain represents the most frequently reported musculoskeletal disorder [2][3][4], entailing discomfort, limited range of motion (ROM), and decreased functional abilities, all of which significantly affect the quality of life [5]. Rotator cuff tendinitis, impingement syndrome, rotator cuff lesions, and adhesive capsulitis constitute the primary etiologies [1,6,7].…”