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临床试验/NCT03476148
NCT03476148Unknown不适用

Effect of Home-Based Rehabilitation Using Interactive Motion Tracking Device on Function and Patient Satisfaction After Total Knee Arthroplasty

The Catholic University of Korea0 个研究点目标入组 60 人开始时间: 2018年3月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
主要终点
Change in Knee Society Score

研究概览

简要总结

Rehabilitation after total knee arthroplasty is very important in terms of range of motion of the knee, muscle power, normal gait, pain control and consequently the patient's satisfaction. Convectional rehabilitation methods in assist of therapist required high demand of resources. Recently, outpatient clinic or tele-communication tool based rehabilitations were investigated and reported equivalent results. However, those methods also required group or one-to-one facing that restricted availability of the exercise.

With development of the motion tracking technology, new device that gives real time feedback with augmented reality images can be used for rehabilitation in home-based setting.

This study aims to compare the clinical outcomes after the rehabilitation by interactive home-based device or conventional inpatient setting.

详细描述

The objective of this work is to compare the pain, stiffness, function and satisfaction between groups at 6 months after the total knee arthroplasty.

The investigators hypothesized that the clinical outcomes of rehabilitation by interactive home-based device are not inferior than that by conventional inpatient setting.

The study design is a single-blind non-randomized controlled trial. Patients takes different rehabilitation method but the outcome assessor is blinded. The clinical outcome is compared at preoperative, postoperative 6weeks, 3months. And clinical outcome consists of Range of Motion (ROM), WOMAC (Western Ontario and McMaster University Arthritis Index ) score, Knee Society Score, Time-up-go (TUG) test.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •over 19 year old
  • •Patients for total knee arthroplasty of one knee
  • •Patients who can understand and utilize the device

排除标准

  • •who don't agree with participation of the study
  • •who can not understand and utilize the device
  • •Rheumatoid arthritis, Other inflammatory arthritis
  • •Neuropsychiatric patients

研究组 & 干预措施

Interactive Device Rehabilitation

Experimental

干预措施: Home Rehabilitation using Interactive device (Device)

Inpatient Rehabilitation

Active Comparator

干预措施: Inpatient Rehabilitation (Other)

结局指标

主要结局

Change in Knee Society Score

时间窗: preoperative, postoperative at 6, 12 weeks

Change in Western Ontario and McMaster Universities Index(WOMAC index)

时间窗: preoperative, postoperative at 6, 12 weeks

Change in Time-Up-Go (TUG) test

时间窗: preoperative, postoperative at 6, 12 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yong In

Professor

The Catholic University of Korea

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