Home Rehabilitation Using Interactive Device Versus Inpatient Rehabilitation in Total Knee Arthroplasty

March 18, 2018 updated by: Yong In, The Catholic University of Korea

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interactive Device Rehabilitation
Device: Home Rehabilitation using Interactive device
Rehabilitation is performed using interactive motion tracking augmented reality device. 6 exercises are included in one-day rehabilitation program. Each exercise is recorded in aspect of compliance, completion.
Active Comparator: Inpatient Rehabilitation
Other: Inpatient Rehabilitation
Patients are given the exercises in the setting of inpatient rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Western Ontario and McMaster Universities Index(WOMAC index)
Time Frame: preoperative, postoperative at 6, 12 weeks
preoperative, postoperative at 6, 12 weeks
Change in Knee Society Score
Time Frame: preoperative, postoperative at 6, 12 weeks
preoperative, postoperative at 6, 12 weeks
Change in Time-Up-Go (TUG) test
Time Frame: preoperative, postoperative at 6, 12 weeks
preoperative, postoperative at 6, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 22, 2018

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

March 21, 2020

Study Registration Dates

First Submitted

March 13, 2018

First Submitted That Met QC Criteria

March 18, 2018

First Posted (Actual)

March 23, 2018

Study Record Updates

Last Update Posted (Actual)

March 23, 2018

Last Update Submitted That Met QC Criteria

March 18, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rehab. Home vs inpatient

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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