Total Knee ReplacementNCT02413996
Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty
A study testing Kinetec® knee continuous passive motion (CPM ), Functional activities and VRRS rehabilitation in people with Total Knee Replacement and Virtual Reality Therapy, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
The aim of this study is to assess the efficacy of virtual rehabilitation through the Virtual Reality Rehabilitation System (VRRS) versus traditional rehabilitation improving the functional outcomes after primary Total Knee Arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Total Knee Replacement, Virtual Reality Therapy, Osteoarthritis
- What is being tested?
- Kinetec® knee continuous passive motion (CPM ), Functional activities and VRRS rehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2014to 25 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary unilateral TKA for knee osteoarthritis
- informed consent
Who cannot join
- people with unstable serious disease (e.g., heart or lung disease)
- people with previous orthopedics pathologies on the same side (e.g., hip arthroprosthesis)
- pregnancy
- psychotropic drugs assumption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty: A Randomised Controlled Trial
The aim of this study is to assess the efficacy of virtual rehabilitation through the Virtual Reality Rehabilitation System (VRRS) versus traditional rehabilitation improving the functional outcomes after primary Total Knee Arthroplasty (TKA).
Read the detailed description
Following ethics approval by the Ospedale San Raffaele, 84 adults aged between 45 and 80 years old will be recruited for the study, excluding people with unstable serious disease (e.g., heart or lung disease), previous orthopedics pathologies on the same side (e.g., hip arthroprosthesis), pregnancy and intake of psychotropic drugs.
Patients who consent to participate in this study will be randomized into two rehabilitation groups after TKA: experimental (virtual rehabilitation) and control (traditional rehabilitation). In the experimental arm, subjects will undergo a virtual rehabilitation training during the post-surgical rehabilitation period, in addition to passive knee range of motion device (kinetec) and functional activity (stairs). In the control arm, subjects with similar demographic characteristics to those of the experimental arm, will undergo the usual physiotherapy rehabilitation, in addition to passive knee range of motion device (kinetec) and functional activity (stairs). Both control and study interventions will be provided 60 minute daily session.
General status of patients will be undertaken for the following outcomes at the baseline and 10 days after surgery (at discharge).
The primary outcome will be the visual analogue scale (VAS); the secondary outcomes will be: the disability knee assessed by the Western Ontario and McMaster Universities (WOMAC), the health related quality of life assessed by the EuroQol (EQ-5D), the global perceived effect assessed by the GPE score, the functional Independent measure assessed by the FIM questionnaire, the drugs assumption, the isometric strength of quadriceps and hamstrings assessed by dynamometer, the range of motion (R.O.M.) and proprioception assessed by VRRS.
- Conditions
- Total Knee Replacement, Virtual Reality Therapy, Osteoarthritis, Knee Arthroplasty, Rehabilitation
- Being tested
- Kinetec® knee continuous passive motion (CPM ), Functional activities, VRRS rehabilitation, traditional rehabilitation
- Keywords
- Virtual Reality Therapy, Rehabilitation, Total Knee Replacement, Knee Arthroplasty, Exercise, Arthritis, Rheumatic Disease
- Medical subject headings
- Osteoarthritis, Motor Activity, Arthritis, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinetec® knee continuous passive motion (CPM )Device
CPM of the knee
Functional activitiesBehavioural
Stairs, walking
VRRS rehabilitationOther
exercise therapy through a virtual reality rehabilitation system (VRRS)
traditional rehabilitationOther
exercise therapy through a traditional rehabilitation training made by physiotherapists
| Study group | Role | What they receive |
|---|---|---|
| VRRS rehabilitation | Experimental | exercise therapy through a virtual reality rehabilitation system (VRRS) in addition to a knee continuous passive motion device ( Kinetec® continuous passive motion ( CPM )) and functional activities (e.g.,stairs, walking) Receives: Device: Kinetec® knee continuous passive motion (CPM ); Behavioral: Functional activities; Other: VRRS rehabilitation |
| traditional rehabilitation | Active comparator | exercise therapy through a traditional rehabilitation training in addition to a knee continuous passive motion device ( Kinetec® continuous passive motion ( CPM )) and functional activities (e.g.,stairs, walking) Receives: Device: Kinetec® knee continuous passive motion (CPM ); Behavioral: Functional activities; Other: traditional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain: Visual Analogue Scale (VAS)
The VAS scale was measured in a range of 0-100 cm (0 no pain and 100 the worst pain)
Measured: baseline and 10 days (value at day 10 minus value at baseline)
Secondary outcomes (8)
Knee Disability: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Questionnaire
The WOMAC measures five items for pain (score range 0-500), two for stiffness (score range 0-200), and 17 for functional limitation (score range 0-1700) for a total score of 2400 (0= no disability, 2400= highest disability):
- Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing
- Stiffness (2 items): after first waking and later in the day
- Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties
Measured: baseline and 10 days (value at day 10 minus value at baseline)
Knee Active Range of Motion
assessed by Virtual Reality Rehabilitation System (degree of movement)
Measured: assesed and reported at 10 days
Health Related Quality of Life: Euro Quality of Life Five Dimensions Questionnaire (EQ-5D)
The EQ-5D comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.The EQ-5D descriptive system is divided into five levels of perceived problems: LEVEL 1: indicating no problem; LEVEL 2:indicating some problems;LEVEL 3: indicating extreme problems. EQ-5D health states can be summarised using the 5-digit code (e.g., 11111, 12311).The answers given to ED-5D permit to find 243 5-digit codes defining the health states.The 5-digit code are linked to an unique index derived by applying a formula that attaches values (weights) to each of the levels in each dimension.Weights depend on the country (Italian Population-Based Values of EQ-5D HealthStates,Scalone 2013).The index has been calculated by deducting the appropriate weights from 1 which is the best health status as highest score (i.e. the corresponding 5-digit code is 11111) and -0.38 for the worst health status as minimum score (i.e., the corresponding 5-digit code is 33333).
Measured: assessed and reported at 10 days
Global Perceived Effect (GPE)
The GPE scale asks the patient to rate, on a numerical scale, how much their condition has improved or deteriorated since some predefined time point. The GPE was administered at the end of the physiotherapy treatment to measure the effect of the intervention on patients' health status perception. This Likert scale had five response options (5 = Very much improved; 4 = Much improved, 3 = No change, 2 = Much worse, 1 = Very much worse).
Measured: assessed and reported at 10 days
The Functional Independence Measure (FIM) Scale
The FIM scale assesses physical and cognitive disability focusing on the level of disability indicating the burden of caring for them. The total score is 126 (18=highest disability, 126=no disability).
Measured: baseline and 10 days (value at day 10 minus value at baseline)
Proprioception
assessed by Virtual Reality Rehabilitation System (percentage value of similarity between ideal and patient knee movement trajector)
Measured: assessed and reported at 10 day
Isometric Strength of Quadriceps and Hamstrings
Isometric strength of quadriceps and hamstrings is assessed by dynamometer (newton unit)
Measured: baseline and 10 days (value at day 10 minus value at baseline)
Drugs Assumption
number of drugs assumpted for each group during rehabilitation recovery
Measured: value at day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startSep 2014
- Primary completion5 May 2018
- Study completion25 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- 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
- Model description
- A phase III randomized clinical trial was approved by the San Raffaele Hospital's Ethic Committee of Milan (31/03/2014)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Tornese, I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Investigators
- Giuseppe Banfi, MD, Study director, IRCCS Galeazzi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413996
- Sponsor's protocol ID
- VRRS
- Status last verified
- Dec 2019
- First submitted
- 11 Mar 2015
- Last updated
- 9 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gianola S, Stucovitz E, Castellini G, Mascali M, Vanni F, Tramacere I, Banfi G, Tornese D. Effects of early virtual reality-based rehabilitation in patients with total knee arthroplasty: A randomized controlled trial. Medicine (Baltimore). 2020 Feb;99(7):e19136. doi: 10.1097/MD.0000000000019136.
PubMed 32049833
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. 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 Arthroplasty: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02413996
- Acronym / sponsor ID
- VRRS
- Conditions
- Total Knee Replacement, Virtual Reality Therapy, Osteoarthritis, Knee Arthroplasty, Rehabilitation
- Keywords
- Virtual Reality Therapy, Rehabilitation, Total Knee Replacement, Knee Arthroplasty, Exercise, Arthritis, Rheumatic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- 5 May 2018 (actual)
- Study completion
- 25 May 2018 (actual)
- First posted
- 10 Apr 2015 (estimated)
- Results
- Posted 9 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess the efficacy of virtual rehabilitation through the Virtual Reality Rehabilitation System (VRRS) versus traditional rehabilitation improving the functional outcomes after primary Total Knee Arthroplasty (TKA).
Detailed description
Following ethics approval by the Ospedale San Raffaele, 84 adults aged between 45 and 80 years old will be recruited for the study, excluding people with unstable serious disease (e.g., heart or lung disease), previous orthopedics pathologies on the same side (e.g., hip arthroprosthesis), pregnancy and intake of psychotropic drugs.
Patients who consent to participate in this study will be randomized into two rehabilitation groups after TKA: experimental (virtual rehabilitation) and control (traditional rehabilitation). In the experimental arm, subjects will undergo a virtual rehabilitation training during the post-surgical rehabilitation period, in addition to passive knee range of motion device (kinetec) and functional activity (stairs). In the control arm, subjects with similar demographic characteristics to those of the experimental arm, will undergo the usual physiotherapy rehabilitation, in addition to passive knee range of motion device (kinetec) and functional activity (stairs). Both control and study interventions will be provided 60 minute daily session.
General status of patients will be undertaken for the following outcomes at the baseline and 10 days after surgery (at discharge).
The primary outcome will be the visual analogue scale (VAS); the secondary outcomes will be: the disability knee assessed by the Western Ontario and McMaster Universities (WOMAC), the health related quality of life assessed by the EuroQol (EQ-5D), the global perceived effect assessed by the GPE score, the functional Independent measure assessed by the FIM questionnaire, the drugs assumption, the isometric strength of quadriceps and hamstrings assessed by dynamometer, the range of motion (R.O.M.) and proprioception assessed by VRRS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A phase III randomized clinical trial was approved by the San Raffaele Hospital's Ethic Committee of Milan (31/03/2014)
| Arm | Type | Receives |
|---|---|---|
| VRRS rehabilitation | Experimental | Device: Kinetec® knee continuous passive motion (CPM ), Behavioral: Functional activities, Other: VRRS rehabilitationexercise therapy through a virtual reality rehabilitation system (VRRS) in addition to a knee continuous passive motion device ( Kinetec® continuous passive motion ( CPM )) and functional activities (e.g.,stairs, walking) |
| traditional rehabilitation | Active comparator | Device: Kinetec® knee continuous passive motion (CPM ), Behavioral: Functional activities, Other: traditional rehabilitationexercise therapy through a traditional rehabilitation training in addition to a knee continuous passive motion device ( Kinetec® continuous passive motion ( CPM )) and functional activities (e.g.,stairs, walking) |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- primary unilateral TKA for knee osteoarthritis
- informed consent
Key exclusion criteria (4 listed)
- people with unstable serious disease (e.g., heart or lung disease)
- people with previous orthopedics pathologies on the same side (e.g., hip arthroprosthesis)
- pregnancy
- psychotropic drugs assumption
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 |
|---|---|---|
| Kinetec® knee continuous passive motion (CPM )CPM of the knee | Device | VRRS rehabilitation, traditional rehabilitation |
| Functional activitiesStairs, walking | Behavioural | VRRS rehabilitation, traditional rehabilitation |
| VRRS rehabilitationexercise therapy through a virtual reality rehabilitation system (VRRS) | Other | VRRS rehabilitation |
| traditional rehabilitationexercise therapy through a traditional rehabilitation training made by physiotherapists | Other | traditional rehabilitation |
Primary outcome
Pain: Visual Analogue Scale (VAS)
Time frame: baseline and 10 days (value at day 10 minus value at baseline)
The VAS scale was measured in a range of 0-100 cm (0 no pain and 100 the worst pain)
8 secondary outcomes
Knee Disability: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Questionnaire
Time frame: baseline and 10 days (value at day 10 minus value at baseline)
Knee Active Range of Motion
Time frame: assesed and reported at 10 days
Health Related Quality of Life: Euro Quality of Life Five Dimensions Questionnaire (EQ-5D)
Time frame: assessed and reported at 10 days
Global Perceived Effect (GPE)
Time frame: assessed and reported at 10 days
The Functional Independence Measure (FIM) Scale
Time frame: baseline and 10 days (value at day 10 minus value at baseline)
Proprioception
Time frame: assessed and reported at 10 day
Isometric Strength of Quadriceps and Hamstrings
Time frame: baseline and 10 days (value at day 10 minus value at baseline)
Drugs Assumption
Time frame: value at day 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32049833Gianola S, Stucovitz E, Castellini G, Mascali M, Vanni F, Tramacere I, Banfi G, Tornese D. Effects of early virtual reality-based rehabilitation in patients with total knee arthroplasty: A randomized controlled trial. Medicine (Baltimore). 2020 Feb;99(7):e19136. doi: 10.1097/MD.0000000000019136.
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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.
Giuseppe Banfi, MD study director
IRCCS Galeazzi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinetec® knee continuous passive motion (CPM ), Functional activities and VRRS rehabilitation in people with Total Knee Replacement and Virtual Reality Therapy, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio 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 2 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 9 Jan 2020. 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?
Yes. Results are posted in the registry (first posted 9 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain: Visual Analogue Scale (VAS) (time frame: baseline and 10 days (value at day 10 minus value at baseline)). 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 NCT02413996, which also lists 1 linked publication.
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 9 Jan 2020.