Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty: A Randomised Controlled Trial

Conditions
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Total Knee Replacement, Virtual Reality Therapy, Osteoarthritis, Knee Arthroplasty, Rehabilitation

Intervention / Treatment
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* Device: Kinetec® knee continuous passive motion (CPM )
* Behavioral: Functional activities
* Other: VRRS rehabilitation
* Other: traditional rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary unilateral TKA for knee osteoarthritis informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VRRS rehabilitation<br>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) | Device: Kinetec® knee continuous passive motion (CPM )<br>* CPM of the knee<br>Behavioral: Functional activities<br>* Stairs, walking<br>Other: VRRS rehabilitation<br>* exercise therapy through a virtual reality rehabilitation system (VRRS)<br>|
| Active Comparator: traditional rehabilitation<br>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) | Device: Kinetec® knee continuous passive motion (CPM )<br>* CPM of the knee<br>Behavioral: Functional activities<br>* Stairs, walking<br>Other: traditional rehabilitation<br>* exercise therapy through a traditional rehabilitation training made by physiotherapists<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | baseline and 10 days (value at day 10 minus value at baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 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). | 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). | 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). | 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) | assessed and reported at 10 day | 
| Isometric Strength of Quadriceps and Hamstrings | Isometric strength of quadriceps and hamstrings is assessed by dynamometer (newton unit) | baseline and 10 days (value at day 10 minus value at baseline) | 
| Drugs Assumption | number of drugs assumpted for each group during rehabilitation recovery | value at day 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Arthritis, Rheumatic Disease, Virtual Reality Therapy, Rehabilitation, Total Knee Replacement, Knee Arthroplasty