Jong In Lee1, Ji Hye Hwang2, Seung Mi Yeo3, Ji Young Lim4, Jong Geol Do3, Jae-Young Lim5. 1. Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 222, Banpo-daero, Seocho-gu, Seoul, 06591, Republic of Korea. ljikyh@catholic.ac.kr. 2. Department of Physical and Rehabilitation Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. hwanglee@skku.edu. 3. Department of Physical and Rehabilitation Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. 4. Department of Physical Therapy, General School of Medical Sciences, Konyang University, Daejeon, Republic of Korea. 5. Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Republic of Korea.
Abstract
BACKGROUND: As the primary treatment for adhesive capsulitis, intensive and accurate home exercise is as important as physical therapy in hospitals. Augmented reality (AR)-based telerehabilitation has been implemented recently in various musculoskeletal conditions to increase patient compliance and enable patients to exercise with the correct posture. The objective of this study is to present a protocol for investigating the additive effect of interactive AR-based telerehabilitation in comparison with the usual care for patients with adhesive capsulitis. METHODS: This study presents the protocol of a prospective, multi-center, single-blinded, two-armed randomized controlled trial (RCT). One hundred patients with stage I or II adhesive capsulitis will be recruited at the physical medicine and rehabilitation clinic. Patients will be randomly divided into two groups with 1:1 allocation. The intervention group will receive 3 months of hospital-based physical therapy in conjunction with home-based telerehabilitation. The control group will receive 3 months of hospital-based physical therapy in conjunction with a home-based exercise described in a brochure provided by the hospital. The primary outcome will be the change in passive range of motion (ROM) of the affected shoulder joint from baseline to 12 weeks after baseline assessment. The secondary outcomes will be active ROM, pain measured with the numeric rating scale, shoulder pain and disability index, 36-Item Short Form Survey, EuroQoL-5D-5L, and Canadian Occupational Performance Measure. DISCUSSION: This will be the first RCT study protocol to investigate the effect of telerehabilitation in patients with adhesive capsulitis. The result of this RCT will determine whether AR-based telerehabilitation is more effective than a brochure-based home exercise program and will provide evidence of the usefulness of "telerehabilitation" using hardware (IoT) and software (monitoring platform) technologies to develop "digital therapeutics" for the future. TRIAL REGISTRATION: This trial was retrospectively registered at the Clinicaltrials.gov website on 20 March 2020, with the identifier NCT04316130 .
RCT Entities:
BACKGROUND: As the primary treatment for adhesive capsulitis, intensive and accurate home exercise is as important as physical therapy in hospitals. Augmented reality (AR)-based telerehabilitation has been implemented recently in various musculoskeletal conditions to increase patient compliance and enable patients to exercise with the correct posture. The objective of this study is to present a protocol for investigating the additive effect of interactive AR-based telerehabilitation in comparison with the usual care for patients with adhesive capsulitis. METHODS: This study presents the protocol of a prospective, multi-center, single-blinded, two-armed randomized controlled trial (RCT). One hundred patients with stage I or II adhesive capsulitis will be recruited at the physical medicine and rehabilitation clinic. Patients will be randomly divided into two groups with 1:1 allocation. The intervention group will receive 3 months of hospital-based physical therapy in conjunction with home-based telerehabilitation. The control group will receive 3 months of hospital-based physical therapy in conjunction with a home-based exercise described in a brochure provided by the hospital. The primary outcome will be the change in passive range of motion (ROM) of the affected shoulder joint from baseline to 12 weeks after baseline assessment. The secondary outcomes will be active ROM, pain measured with the numeric rating scale, shoulder pain and disability index, 36-Item Short Form Survey, EuroQoL-5D-5L, and Canadian Occupational Performance Measure. DISCUSSION: This will be the first RCT study protocol to investigate the effect of telerehabilitation in patients with adhesive capsulitis. The result of this RCT will determine whether AR-based telerehabilitation is more effective than a brochure-based home exercise program and will provide evidence of the usefulness of "telerehabilitation" using hardware (IoT) and software (monitoring platform) technologies to develop "digital therapeutics" for the future. TRIAL REGISTRATION: This trial was retrospectively registered at the Clinicaltrials.gov website on 20 March 2020, with the identifier NCT04316130 .
Authors: Maria Jesus Vinolo Gil; Gloria Gonzalez-Medina; David Lucena-Anton; Veronica Perez-Cabezas; María Del Carmen Ruiz-Molinero; Rocío Martín-Valero Journal: JMIR Serious Games Date: 2021-12-15 Impact factor: 4.143