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

Gowun Kim, Won-Seok Kim, Tae Woo Kim, Yong Seuk Lee, Hooman Lee, Nam-Jong Paik, Gowun Kim, Won-Seok Kim, Tae Woo Kim, Yong Seuk Lee, Hooman Lee, Nam-Jong Paik

Abstract

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.

Conflict of interest statement

HL is the founder and chief executive officer of Exosystems (Seongnam, South Korea), which is the manufacturer of the device. Exosystems supplied the product, and unrestricted technical and customer support. Other authors have no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
Schedule of enrolment, interventions, and assessments. T0: enrollment; T1: baseline variables; T2: allocation; T3: 2-wk after intervention initiation; T4: 6-wk after intervention initiation (endpoint of intervention, post-intervention evaluation); AROM = active range of motion, IKDC = International Knee Documentation Committee (IKDC questionnaire), KOS-ADLS = knee outcome survey activities of daily living scale, Lysholm = Lysholm knee scoring scale, PROM = passive range of motion, QoL = quality of life, RMS = root mean square, sEMG = surface electromyography, VAS = visual analog scale.
Figure 2
Figure 2
Flow diagram of the study.
Figure 3
Figure 3
A smart wearable knee exercise and electrical stimulation device. (A) User wearing device; (B) one of the games for range of motion exercise; (C) screenshot of subject exercises using the bio-feedback – the left side of the screen shows the threshold; (D) screenshot of the neuromuscular electrical stimulation setting.

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Source: PubMed

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