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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03476148
Other study ID # Rehab. Home vs inpatient
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 13, 2018
Last updated March 18, 2018
Start date March 22, 2018
Est. completion date March 21, 2020

Study information

Verified date March 2018
Source The Catholic University of Korea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date March 21, 2020
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender Female
Age group 19 Years and older
Eligibility 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 Design


Intervention

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.
Other:
Inpatient Rehabilitation
Patients are given the exercises in the setting of inpatient rehabilitation

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The Catholic University of Korea

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Western Ontario and McMaster Universities Index(WOMAC index) preoperative, postoperative at 6, 12 weeks
Primary Change in Knee Society Score preoperative, postoperative at 6, 12 weeks
Primary Change in Time-Up-Go (TUG) test preoperative, postoperative at 6, 12 weeks
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