Osteoarthritis Clinical Trial
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).
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.
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