NCT01979718|CompletedDMC
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Sponsor study identifier
interventional
60
1 country
1
Study Start
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2016
Actual (reported)Study Completion
June 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
November 3, 2013
Actual (reported)November 8, 2013
Actual (reported)June 2016
Actual (reported)June 2016
Actual (reported)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
Visual analogue scale (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
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
* 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 )
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Ulsan University Hospital
Ulsan, 682-714, South Korea
Chang Ho Hwang, M.D., Ph.D.
Ulsan University Hospital
Sung Do Cho, M.D., Ph.D.
Ulsan University Hospital
Youngjoon Chee, Ph.D.
Department of Biomedical Engineering, University of Ulsan
Kyo-In Koo, Ph.D.
Department of Biomedical Engineering, University of Ulsan
60 participants (actual enrollment reported by the registry).
First Submitted
November 3, 2013
First Posted
November 8, 2013
Study Start
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
June 2016
Actual (reported)Study Completion
June 2016
Actual (reported)Last Updated
June 16, 2016
Record last verified: 2016-06
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Source: ClinicalTrials.gov.
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