Osteoarthritis, KneeNCT01979718
The Post-operative Analgesia of the Virtual Reality Using a Mirror Therapy After Total Knee Arthroplasty
A study testing Mirrored Virtual reality in people with Osteoarthritis, Knee and Nociceptive Pain, run by Ulsan University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Knee, Nociceptive Pain, Virtual Reality
- What is being tested?
- Mirrored Virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients who were transferred to RM after unilateral TKA
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Mirrored Virtual reality
- Medical subject headings
- Osteoarthritis, Knee, Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirrored Virtual realityDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Full term intervention | Experimental | * 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. Receives: Device: Mirrored Virtual reality |
| Half term intervention | Active comparator | * 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 ) Receives: Device: Mirrored Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
Secondary outcomes (8)
Visual analogue scale (VAS) while resting
checking the VAS while resting
Measured: 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
Measured: 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
Measured: shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
Tridol consumption per week
Measured: after the 1st and 2nd session (5 days) intervention
WOMAC index
Measured: 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
Measured: 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.
Measured: shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
Side effects
Measured: after the 1st and 2nd session (5 days) intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulsan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Ho Hwang, Ulsan University Hospital
- Investigators
- Chang Ho Hwang, M.D., Ph.D., Principal investigator, Ulsan University HospitalSung Do Cho, M.D., Ph.D., Principal investigator, Ulsan University HospitalYoungjoon Chee, Ph.D., Principal investigator, Department of Biomedical Engineering, University of UlsanKyo-In Koo, Ph.D., Principal investigator, Department of Biomedical Engineering, University of Ulsan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979718
- Sponsor's protocol ID
- chhwang3
- Status last verified
- Jun 2016
- First submitted
- 3 Nov 2013
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01979718
- Acronym / sponsor ID
- chhwang3
- Conditions
- Osteoarthritis, Knee, Nociceptive Pain, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ulsan University HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full term intervention | Experimental | Device: Mirrored Virtual reality* 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. |
| Half term intervention | Active comparator | Device: Mirrored Virtual reality* 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 ) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients who were transferred to RM after unilateral TKA
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirrored Virtual realityPatients 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. | Device | Full term intervention, Half term intervention |
Primary outcome
6 minute walk test
Time frame: shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
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.
8 secondary outcomes
Visual analogue scale (VAS) while resting
Time frame: shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
Visual analogue scale (VAS) while moving
Time frame: 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
Time frame: shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
Tridol consumption per week
Time frame: after the 1st and 2nd session (5 days) intervention
WOMAC index
Time frame: shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
Graded ambulation distances
Time frame: shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
Timed-stands test
Time frame: shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
Side effects
Time frame: after the 1st and 2nd session (5 days) intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang Ho Hwang, M.D., Ph.D. principal investigator
Ulsan University Hospital
Sung Do Cho, M.D., Ph.D. principal investigator
Ulsan University Hospital
Youngjoon Chee, Ph.D. principal investigator
Department of Biomedical Engineering, University of Ulsan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirrored Virtual reality in people with Osteoarthritis, Knee and Nociceptive Pain, run by Ulsan University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minute walk test (time frame: shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2016.