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

NCT ID: NCT01979718

Last Updated: 2016-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-06-30

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.

Conditions

Osteoarthritis, Knee; Nociceptive Pain; Virtual Reality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Full term 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.

Group Type: EXPERIMENTAL

Mirrored Virtual reality

Intervention Type: DEVICE

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.

Half term intervention

• 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 )

Group Type: ACTIVE_COMPARATOR

Mirrored Virtual reality

Intervention Type: DEVICE

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.

Interventions

Mirrored Virtual reality

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.

Intervention Type: DEVICE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ulsan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chang Ho Hwang

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chang Ho Hwang, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ulsan University Hospital

Sung Do Cho, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ulsan University Hospital

Youngjoon Chee, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Biomedical Engineering, University of Ulsan

Kyo-In Koo, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Biomedical Engineering, University of Ulsan

Locations

Ulsan University Hospital

Ulsan, , South Korea

Countries

South Korea

Other Identifiers

chhwang3

Identifier Type: -

Identifier Source: org_study_id