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

Primary Purpose

Osteoarthritis, Knee, Nociceptive Pain, Virtual Reality

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mirrored Virtual reality
Sponsored by
Ulsan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ulsan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Full term intervention

Half term intervention

Arm Description

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.

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 )

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Visual analogue scale (VAS) while resting
checking the VAS while resting
Visual analogue scale (VAS) while moving
checking the VAS while resting
Active ROM of flexion and extension on the knee
Tridol consumption per week
WOMAC index
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
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.
Side effects

Full Information

First Posted
November 3, 2013
Last Updated
June 15, 2016
Sponsor
Ulsan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01979718
Brief Title
The Post-operative Analgesia of the Virtual Reality Using a Mirror Therapy After Total Knee Arthroplasty
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ulsan University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Nociceptive Pain, Virtual Reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Full term intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Half term intervention
Arm Type
Active Comparator
Arm Description
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 )
Intervention Type
Device
Intervention Name(s)
Mirrored Virtual reality
Intervention Description
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.
Primary Outcome Measure Information:
Title
6 minute walk test
Description
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.
Time Frame
shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
Secondary Outcome Measure Information:
Title
Visual analogue scale (VAS) while resting
Description
checking the VAS while resting
Time Frame
shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
Title
Visual analogue scale (VAS) while moving
Description
checking the VAS while resting
Time Frame
shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
Title
Active ROM of flexion and extension on the knee
Time Frame
shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
Title
Tridol consumption per week
Time Frame
after the 1st and 2nd session (5 days) intervention
Title
WOMAC index
Time Frame
shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
Title
Graded ambulation distances
Description
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
Time Frame
shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
Title
Timed-stands test
Description
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.
Time Frame
shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
Title
Side effects
Time Frame
after the 1st and 2nd session (5 days) intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Ho Hwang, M.D., Ph.D.
Organizational Affiliation
Ulsan University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sung Do Cho, M.D., Ph.D.
Organizational Affiliation
Ulsan University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Youngjoon Chee, Ph.D.
Organizational Affiliation
Department of Biomedical Engineering, University of Ulsan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kyo-In Koo, Ph.D.
Organizational Affiliation
Department of Biomedical Engineering, University of Ulsan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ulsan University Hospital
City
Ulsan
ZIP/Postal Code
682-714
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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