Knee ArthropathyVRRS_KNEENCT03454256
Virtual Reality Rehabilitation in Patients With Total Knee Replacement
A study testing Virtual Reality in people with Knee Arthropathy and Total Knee Replacement, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial summary
Impaired proprioceptive accuracy could be a risk factor for progression of gait limitations in knee osteoarthritis patients, even after the Total Knee Replacement (TKR). Recent studies on Virtual Reality (VR) in rehabilitation show its efficacy in restoring proprioceptive capacity, postural control and gait. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Arthropathy, Total Knee Replacement
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 8 Nov 2016to 13 Nov 2019
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- recruitment and initial assessment within 10 days of surgery;
- monolateral knee arthroplasty in election;
- collaborating patients who are able to perform the proposed exercise;
- good cardiovascular compensation;
- cognitively intact;
- able to provide informed consent;
Who cannot join
- no severe cognitive / behavioral deficit;
- refusal or inability to provide informed consent;
- presence of sever cardiorespiratory co-morbidities;
- peripheral and /or central neurological deficits;
- visual deficits;
- presence of serious osteo-arthro-muscular diseases at controlateral lower limb against the prosthetic side;
- complication at surgical wound
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Virtual Reality Rehabilitation in Patients With Total Knee Replacement
Impaired proprioceptive accuracy could be a risk factor for progression of gait limitations in knee osteoarthritis patients, even after the Total Knee Replacement (TKR). Recent studies on Virtual Reality (VR) in rehabilitation show its efficacy in restoring proprioceptive capacity, postural control and gait. However, literature lacks such studies in TKR patients. This preliminary study aims to evaluate the efficacy of a VR system for the enhancement of motor skills in TKR patients compared to a traditional approach of rehabilitation.
Read the detailed description
In this randomized controlled trial (RCT), the randomization of the sample will be performed by a local software and in a single blind design. Forty patients will be enrolled and after giving the informed consent, assigned to two groups :
- the experimental group (VRG), which will be undergone to treatment with virtual reality for the recovery of load distribution and proper gait pattern;
- the control group (CG), which will be undergone to a traditional rehabilitation addressed to recovery of correct gait pattern for the same time period as VRG.
Both treatments consist in 15 sessions, at least 5 per week , each lasting 45 minutes. Both VRG or CG will last for 21 days from the start of treatment.
All patients, in adjunction to Virtual Reality Rehabilitation (EG) or Traditional Rehabilitation (CG), will execute a global rehabilitation project, consisting in Physiotherapy, Physical Therapies for pain and inflammation control, and Occupational Therapy, personalized by a multidisciplinary rehabilitation team for a minimum of 150-180 minutes per day, and according to their clinical conditions for them.
The purposes of this study in detail are:
- Observing differences in the distribution of the bi-podalic load in the group that performs a re-education with virtual reality compared to those who perform the traditional treatment.
- Observing differences in the recovery time of a correct pattern of gait in the group that performs a re-education with virtual reality compared to those who perform a traditional treatment.
- Observing changes in neurophysiological patterns in the two groups.
- Conditions
- Knee Arthropathy, Total Knee Replacement
- Being tested
- Virtual Reality
- Keywords
- Virtual Reality, Total Knee Replacement, Proprioception, Balance, Gait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Also called VRRS EVO, Khymeia s.r.l., Italy
Virtual Reality Rehabilitation System
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group (VRG) | Experimental | The Virtual Reality Group (VRG) will perform the rehabilitation trough the Virtual Reality Rehabilitation system (VRRS, Khymeia,Italy). The patient standing upright on a balance board will practice exercises of vertical position control with a visual biofeedback received from the VRRS and interacting with the serious video-games. The difficulty level of the exercises will increase gradually session by session. Every session will last 45 minutes with a frequency of at least 5 times a week. Receives: Device: Virtual Reality |
| Control Group (CG) | No intervention | The Control Group (CG) will perform the traditional treatment consisting of the exercises of rehabilitation of gait and postural passages, exercises for postural control, and proprioceptive exercises in a vertical position according to the method chosen by the physiotherapist. Every session will last 45 minutes with a frequency of at least 5 times a week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Time Up and Go (TUG)
The TUG is a timed test used to assess mobility, balance, and walking in people with balance impairments. The subject must stand up from a chair (which should not be leaned up against a wall), walk a distance of 3 meters, turn around, walk back to the chair and sit down - all performed as quickly and as safely as possible.
Measured: Session 1 (baseline) and session 15 (day 21)
Secondary outcomes (5)
Change in 10 Meter Walk Test (10-MWT)
The 10-MWT examine the patient's gait speed. Patients will be directed to walk at their preferred maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 second). The test will be recorded 3 times, with adequate rest in between. The average of the 3 times should be recorded.
Measured: Session 1 (baseline) and session 15 (day 21)
Change in Medical Research Council scale (MRC)
The MRC will be used to evaluate the muscle strength of Quadriceps Femoris (QF) and Tibialis Anterior (TA). The muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle.
Measured: Session 1 (baseline) and session 15 (day 21)
Change in Visual Analog Scale (VAS)
VAS is a 0-10 rating scale for pain which is used to gain a subjective report of the intensity of a person's pain. Zero represents "no pain" and ten represents "the most intense pain imaginable". A meaningful change would be plus or minus 3 points.
Measured: Session 1 (baseline) and session 15 (day 21)
Change in Barthel Index (BI)
The BI is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. It uses ten variables describing ADL and mobility. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital.
Measured: Session 1 (baseline) and session 15 (day 21)
MiniMental State evaluation (MMSE)
The MMSE (Folstein et al., 1975), is a 30-point questionnaire that is used extensively in clinical and research settings to measure intellectual efficiency disorder as well as cognitive impairment.
Measured: Session 1 (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start8 Nov 2016
- Primary completion8 Oct 2019
- Study completion13 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Knee ArthropathyStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Franceschini, MD, Study chair, IRCCS Sanraffaele Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454256
- Sponsor's protocol ID
- RP 15/16
- Acronym
- VRRS_KNEE
- Status last verified
- Apr 2024
- First submitted
- 26 Feb 2018
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Knoop J, Steultjens MP, van der Leeden M, van der Esch M, Thorstensson CA, Roorda LD, Lems WF, Dekker J. Proprioception in knee osteoarthritis: a narrative review. Osteoarthritis Cartilage. 2011 Apr;19(4):381-8. doi: 10.1016/j.joca.2011.01.003. Epub 2011 Jan 18.
PubMed 21251988Laver K, George S, Thomas S, Deutsch JE, Crotty M. Cochrane review: virtual reality for stroke rehabilitation. Eur J Phys Rehabil Med. 2012 Sep;48(3):523-30. Epub 2012 Jun 20.
PubMed 22713539Fung V, Ho A, Shaffer J, Chung E, Gomez M. Use of Nintendo Wii Fit in the rehabilitation of outpatients following total knee replacement: a preliminary randomised controlled trial. Physiotherapy. 2012 Sep;98(3):183-8. doi: 10.1016/j.physio.2012.04.001. Epub 2012 Jul 10.
PubMed 22898573Lee M, Suh D, Son J, Kim J, Eun SD, Yoon B. Patient perspectives on virtual reality-based rehabilitation after knee surgery: Importance of level of difficulty. J Rehabil Res Dev. 2016;53(2):239-52. doi: 10.1682/JRRD.2014.07.0164.
PubMed 27149529Negus JJ, Cawthorne DP, Chen JS, Scholes CJ, Parker DA, March LM. Patient outcomes using Wii-enhanced rehabilitation after total knee replacement - the TKR-POWER study. Contemp Clin Trials. 2015 Jan;40:47-53. doi: 10.1016/j.cct.2014.11.007. Epub 2014 Nov 12.
PubMed 25460343Levinger P, Zeina D, Teshome AK, Skinner E, Begg R, Abbott JH. A real time biofeedback using Kinect and Wii to improve gait for post-total knee replacement rehabilitation: a case study report. Disabil Rehabil Assist Technol. 2016;11(3):251-62. doi: 10.3109/17483107.2015.1080767. Epub 2015 Sep 4.
PubMed 26336875Dieppe P, Basler HD, Chard J, Croft P, Dixon J, Hurley M, Lohmander S, Raspe H. Knee replacement surgery for osteoarthritis: effectiveness, practice variations, indications and possible determinants of utilization. Rheumatology (Oxford). 1999 Jan;38(1):73-83. doi: 10.1093/rheumatology/38.1.73. No abstract available.
PubMed 10334686Koralewicz LM, Engh GA. Comparison of proprioception in arthritic and age-matched normal knees. J Bone Joint Surg Am. 2000 Nov;82(11):1582-8. doi: 10.2106/00004623-200011000-00011.
PubMed 11097448Pournajaf S, Goffredo M, Pellicciari L, Piscitelli D, Criscuolo S, Le Pera D, Damiani C, Franceschini M. Effect of balance training using virtual reality-based serious games in individuals with total knee replacement: A randomized controlled trial. Ann Phys Rehabil Med. 2022 Nov;65(6):101609. doi: 10.1016/j.rehab.2021.101609. Epub 2022 Sep 29.
PubMed 34839056
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality Rehabilitation in Patients With Total Knee Replacement
- ClinicalTrials.gov ID
- NCT03454256
- Acronym / sponsor ID
- VRRS_KNEE / RP 15/16
- Conditions
- Knee Arthropathy, Total Knee Replacement
- Keywords
- Virtual Reality, Total Knee Replacement, Proprioception, Balance, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 8 Nov 2016 (actual)
- Primary completion
- 8 Oct 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 5 Mar 2018 (actual)
- 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.
Impaired proprioceptive accuracy could be a risk factor for progression of gait limitations in knee osteoarthritis patients, even after the Total Knee Replacement (TKR). Recent studies on Virtual Reality (VR) in rehabilitation show its efficacy in restoring proprioceptive capacity, postural control and gait. However, literature lacks such studies in TKR patients. This preliminary study aims to evaluate the efficacy of a VR system for the enhancement of motor skills in TKR patients compared to a traditional approach of rehabilitation.
Detailed description
In this randomized controlled trial (RCT), the randomization of the sample will be performed by a local software and in a single blind design. Forty patients will be enrolled and after giving the informed consent, assigned to two groups :
- the experimental group (VRG), which will be undergone to treatment with virtual reality for the recovery of load distribution and proper gait pattern;
- the control group (CG), which will be undergone to a traditional rehabilitation addressed to recovery of correct gait pattern for the same time period as VRG.
Both treatments consist in 15 sessions, at least 5 per week , each lasting 45 minutes. Both VRG or CG will last for 21 days from the start of treatment.
All patients, in adjunction to Virtual Reality Rehabilitation (EG) or Traditional Rehabilitation (CG), will execute a global rehabilitation project, consisting in Physiotherapy, Physical Therapies for pain and inflammation control, and Occupational Therapy, personalized by a multidisciplinary rehabilitation team for a minimum of 150-180 minutes per day, and according to their clinical conditions for them.
The purposes of this study in detail are:
- Observing differences in the distribution of the bi-podalic load in the group that performs a re-education with virtual reality compared to those who perform the traditional treatment.
- Observing differences in the recovery time of a correct pattern of gait in the group that performs a re-education with virtual reality compared to those who perform a traditional treatment.
- Observing changes in neurophysiological patterns in the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group (VRG) | Experimental | Device: Virtual RealityThe Virtual Reality Group (VRG) will perform the rehabilitation trough the Virtual Reality Rehabilitation system (VRRS, Khymeia,Italy). The patient standing upright on a balance board will practice exercises of vertical position control with a visual biofeedback received from the VRRS and interacting with the serious video-games. The difficulty level of the exercises will increase gradually session by session. Every session will last 45 minutes with a frequency of at least 5 times a week. |
| Control Group (CG) | No intervention | –The Control Group (CG) will perform the traditional treatment consisting of the exercises of rehabilitation of gait and postural passages, exercises for postural control, and proprioceptive exercises in a vertical position according to the method chosen by the physiotherapist. Every session will last 45 minutes with a frequency of at least 5 times a week. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- recruitment and initial assessment within 10 days of surgery;
- monolateral knee arthroplasty in election;
- collaborating patients who are able to perform the proposed exercise;
- good cardiovascular compensation;
- cognitively intact;
Key exclusion criteria (7 listed)
- no severe cognitive / behavioral deficit;
- refusal or inability to provide informed consent;
- presence of sever cardiorespiratory co-morbidities;
- peripheral and /or central neurological deficits;
- visual deficits;
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 |
|---|---|---|
| Virtual RealityAlso: VRRS EVO, Khymeia s.r.l., ItalyVirtual Reality Rehabilitation System | Device | Virtual Reality Group (VRG) |
Primary outcome
Change in Time Up and Go (TUG)
Time frame: Session 1 (baseline) and session 15 (day 21)
The TUG is a timed test used to assess mobility, balance, and walking in people with balance impairments. The subject must stand up from a chair (which should not be leaned up against a wall), walk a distance of 3 meters, turn around, walk back to the chair and sit down - all performed as quickly and as safely as possible.
5 secondary outcomes
Change in 10 Meter Walk Test (10-MWT)
Time frame: Session 1 (baseline) and session 15 (day 21)
Change in Medical Research Council scale (MRC)
Time frame: Session 1 (baseline) and session 15 (day 21)
Change in Visual Analog Scale (VAS)
Time frame: Session 1 (baseline) and session 15 (day 21)
Change in Barthel Index (BI)
Time frame: Session 1 (baseline) and session 15 (day 21)
MiniMental State evaluation (MMSE)
Time frame: Session 1 (baseline)
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 10 Apr 2024.
- Background: PubMed 21251988Knoop J, Steultjens MP, van der Leeden M, van der Esch M, Thorstensson CA, Roorda LD, Lems WF, Dekker J. Proprioception in knee osteoarthritis: a narrative review. Osteoarthritis Cartilage. 2011 Apr;19(4):381-8. doi: 10.1016/j.joca.2011.01.003. Epub 2011 Jan 18.
- Background: PubMed 22713539Laver K, George S, Thomas S, Deutsch JE, Crotty M. Cochrane review: virtual reality for stroke rehabilitation. Eur J Phys Rehabil Med. 2012 Sep;48(3):523-30. Epub 2012 Jun 20.
- Background: PubMed 22898573Fung V, Ho A, Shaffer J, Chung E, Gomez M. Use of Nintendo Wii Fit in the rehabilitation of outpatients following total knee replacement: a preliminary randomised controlled trial. Physiotherapy. 2012 Sep;98(3):183-8. doi: 10.1016/j.physio.2012.04.001. Epub 2012 Jul 10.
- Background: PubMed 27149529Lee M, Suh D, Son J, Kim J, Eun SD, Yoon B. Patient perspectives on virtual reality-based rehabilitation after knee surgery: Importance of level of difficulty. J Rehabil Res Dev. 2016;53(2):239-52. doi: 10.1682/JRRD.2014.07.0164.
- Background: PubMed 25460343Negus JJ, Cawthorne DP, Chen JS, Scholes CJ, Parker DA, March LM. Patient outcomes using Wii-enhanced rehabilitation after total knee replacement - the TKR-POWER study. Contemp Clin Trials. 2015 Jan;40:47-53. doi: 10.1016/j.cct.2014.11.007. Epub 2014 Nov 12.
- Background: PubMed 26336875Levinger P, Zeina D, Teshome AK, Skinner E, Begg R, Abbott JH. A real time biofeedback using Kinect and Wii to improve gait for post-total knee replacement rehabilitation: a case study report. Disabil Rehabil Assist Technol. 2016;11(3):251-62. doi: 10.3109/17483107.2015.1080767. Epub 2015 Sep 4.
- Background: PubMed 10334686Dieppe P, Basler HD, Chard J, Croft P, Dixon J, Hurley M, Lohmander S, Raspe H. Knee replacement surgery for osteoarthritis: effectiveness, practice variations, indications and possible determinants of utilization. Rheumatology (Oxford). 1999 Jan;38(1):73-83. doi: 10.1093/rheumatology/38.1.73. No abstract available.
- Background: PubMed 11097448Koralewicz LM, Engh GA. Comparison of proprioception in arthritic and age-matched normal knees. J Bone Joint Surg Am. 2000 Nov;82(11):1582-8. doi: 10.2106/00004623-200011000-00011.
- Derived from this study: PubMed 34839056Pournajaf S, Goffredo M, Pellicciari L, Piscitelli D, Criscuolo S, Le Pera D, Damiani C, Franceschini M. Effect of balance training using virtual reality-based serious games in individuals with total knee replacement: A randomized controlled trial. Ann Phys Rehabil Med. 2022 Nov;65(6):101609. doi: 10.1016/j.rehab.2021.101609. Epub 2022 Sep 29.
- 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.
Marco Franceschini, MD study chair
IRCCS Sanraffaele Pisana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Knee Arthropathy and Total Knee Replacement, run by IRCCS San Raffaele Roma at 1 site in Italy.
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 6 inclusion and 7 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 10 Apr 2024. 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 Italy. 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?
Change in Time Up and Go (TUG) (time frame: Session 1 (baseline) and session 15 (day 21)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03454256, which also lists 9 linked publications.
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 10 Apr 2024.