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

Primary Purpose

Osteoarthritis, Knee, Arthroplasty, Rehabilitation

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Home Rehabilitation using Interactive device

Inpatient Rehabilitation

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interactive Device Rehabilitation

Inpatient Rehabilitation

Arm Description

Outcomes

Primary Outcome Measures

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

Change in Knee Society Score

Change in Time-Up-Go (TUG) test

Secondary Outcome Measures

Full Information

NCT ID

NCT03476148

First Posted

March 13, 2018

Last Updated

March 18, 2018

Sponsor

The Catholic University of Korea

1. Study Identification

Unique Protocol Identification Number

NCT03476148

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 22, 2018 (Anticipated)

Primary Completion Date

December 31, 2018 (Anticipated)

Study Completion Date

March 21, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Catholic University of Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee, Arthroplasty, Rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Interactive Device Rehabilitation

Arm Type

Experimental

Arm Title

Inpatient Rehabilitation

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Home Rehabilitation using Interactive device

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Inpatient Rehabilitation

Intervention Description

Patients are given the exercises in the setting of inpatient rehabilitation

Primary Outcome Measure Information:

Title

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

Time Frame

preoperative, postoperative at 6, 12 weeks

Title

Change in Knee Society Score

Time Frame

preoperative, postoperative at 6, 12 weeks

Title

Change in Time-Up-Go (TUG) test

Time Frame

preoperative, postoperative at 6, 12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Learn more about this trial

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

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