The Post-operative Analgesia of the Virtual Reality Using a Mirror Therapy After Total Knee Arthroplasty

Study Overview
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Brief Summary
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It was well known that the mirror therapy could decrease pain of upper-limb amputated patients. The mirror therapy is known to make a plastic change some parts of the brain perceiving the painful body part and modulating its signal by feedback of visual information mirrored with the corresponding contra-lateral normal parts. In this study, post-operative analgesic efficiency of the virtual reality using a mirror therapy after total knee arthroplasty will be evaluated. This clinical trial will be performed in the form of prospective, single-blind (i.e. assessor-blind), parallel group, randomized (allocation ratio 1:1), single cohort.

Official Title
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The Post-operative Analgesia of the Virtual Reality Using a Mirror Therapy After Total Knee Arthroplasty: Prospective, Single-blind, Parallel Group, Randomized, Single Cohort Clinical Trial of Efficacy

Conditions
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Osteoarthritis, Knee, Nociceptive Pain, Virtual Reality

Intervention / Treatment
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* Device: Mirrored Virtual reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who were transferred to RM after unilateral TKA Exclusion Criteria: patients cannot freely move the contralat. leg d/t neurologic or musculoskeletal problems patients are not enough clear to indicate VAS patients cannot look at the virtual reality monitor d/t visual problem refusal of the participation
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full term intervention<br>random selection composed of the daily standard physical treatment and 1 session per one day over two weeks with a break on Saturday and Sunday (1 session is consisted of 50 repetitions of voluntary simultaneous flexion and extension of the both knees, taking a look at the mirrored virtual reality simulating the surgeried knee. | Device: Mirrored Virtual reality<br>* Patients are required to look at the images of both lower extremities ranged from the perineal area to the foot. Virtual reality system records in real-time method both lower extremities. Following the validity assessement mirrored image of the surgeried lower extremity is re-formed using the virtusal reality system flipping the image of lower extremity not-surgeried and being calibration for the symmetricity.<br>|
| Active Comparator: Half term intervention<br>random selection composed of the daily standard physical treatment over two weeks and 1 session per one day over one weeks with a break on Saturday and Sunday (1 session is consisted of 50 repetitions of voluntary simultaneous flexion and extension of the both knees, taking a look at the mirrored virtual reality stimmulating the surgeried knee ) | Device: Mirrored Virtual reality<br>* Patients are required to look at the images of both lower extremities ranged from the perineal area to the foot. Virtual reality system records in real-time method both lower extremities. Following the validity assessement mirrored image of the surgeried lower extremity is re-formed using the virtusal reality system flipping the image of lower extremity not-surgeried and being calibration for the symmetricity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walk test | The distance walked at a self-selected speed along a 40 cm corridor in 6 min. The distance was measured in meters, and more the meters better the result. A walking aid was used if needed. | shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale (VAS) while resting | checking the VAS while resting | shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention | 
| Visual analogue scale (VAS) while moving | checking the VAS while resting | shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention | 
| Active ROM of flexion and extension on the knee |  | shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention | 
| Tridol consumption per week |  | after the 1st and 2nd session (5 days) intervention | 
| WOMAC index |  | shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention | 
| Graded ambulation distances | Grade 1: able to ambulate ≤5 feet Grade 2: able to ambulate >5 feet but <10 feet Grade 3: able to ambulate >10 feet but <30 feet Grade 4: able to ambulate ≥30 feet | shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention | 
| Timed-stands test | The patients were asked to rise from and sit down on a chair with a height of 45 cm, 10 times and as quickly as possible, without using the armrests. The time spent was recorded. | shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention | 
| Side effects |  | after the 1st and 2nd session (5 days) intervention |