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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03476148
Recruitment Status : Unknown
Verified March 2018 by Yong In, The Catholic University of Korea.
Recruitment status was:  Not yet recruiting
First Posted : March 23, 2018
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
Yong In, The Catholic University of Korea

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.


Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Arthroplasty Rehabilitation Device: Home Rehabilitation using Interactive device Other: Inpatient Rehabilitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Home-Based Rehabilitation Using Interactive Motion Tracking Device on Function and Patient Satisfaction After Total Knee Arthroplasty
Estimated Study Start Date : March 22, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 21, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in Western Ontario and McMaster Universities Index(WOMAC index) [ Time Frame: preoperative, postoperative at 6, 12 weeks ]
  2. Change in Knee Society Score [ Time Frame: preoperative, postoperative at 6, 12 weeks ]
  3. Change in Time-Up-Go (TUG) test [ Time Frame: preoperative, postoperative at 6, 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
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Responsible Party: Yong In, Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT03476148    
Other Study ID Numbers: Rehab. Home vs inpatient
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases