Home-based rehabilitation using smart wearable knee exercise device with electrical stimulation after anterior cruciate ligament reconstruction: A study protocol for a randomized controlled trial

INTRODUCTION: Rehabilitation after anterior cruciate ligament (ACL) reconstruction is critical to patient outcome. Despite its importance; however, hospital-based rehabilitation is limited, with barriers, including distance and cost. With recent technological advancements, wearable devices have actively been used to address these barriers. In this study, we propose a randomized controlled trial protocol investigating the efficacy and feasibility of home-based rehabilitation after ACL reconstruction using a smart wearable device providing electrical stimulation that allows knee exercise. METHODS AND ANALYSIS: This is a protocol proposal for a prospective, single-center, randomized, controlled study. We plan to recruit adults discharged after ACL reconstruction; the recruited subjects will be randomly allocated to 1 of 2 groups, using a computer-generated randomization method: the intervention (n = 20) or control group (n = 20). The intervention group will receive a 6-week home-based rehabilitation program using smart wearable device. The control group will undergo a 6-week self-exercise program as normal. The following outcomes will be assessed at baseline, 2 weeks, and 6 weeks post the 6-week intervention program: quadriceps strength of the affect side as measured by a dynamometer (primary outcome); range of motion; root mean square of quadriceps muscle using surface electromyography; knee function using questionnaire; quality of life; subject's satisfaction score using questionnaire; frequency and duration of exercise; and knee pain. An intention-to-treat analysis will be conducted for the primary outcome. DISCUSSION: This study is a prospective, single-center, randomized, controlled study. This study aims to research the feasibility and efficacy of a 6-week, structured home-based rehabilitation program for patients after ACL reconstruction using a smart wearable device. The findings of this study will help to establish a home-based rehabilitation program to better recovery in patients with ACL reconstruction. TRIAL REGISTRATION NUMBER: This protocol was registered in ClinicalTrials.gov, under the number NCT04079205.