Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty
Condition: Total Knee Replacement; Virtual Reality Therapy; Osteoarthritis; Knee Arthroplasty; Rehabilitation
MeSH terms: Osteoarthritis
Study type: Interventional

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).
    

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.
    

Intervention name(s): Kinetec® knee continuous passive motion (CPM ); Functional activities; VRRS rehabilitation; traditional rehabilitation
Intervention type(s): Device; Behavioral; Other; Other
Intervention description(s): CPM of the knee; Stairs, walking; exercise therapy through a virtual reality rehabilitation system (VRRS); exercise therapy through a traditional rehabilitation training made by physiotherapists
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Virtual Reality Therapy; Rehabilitation; Total Knee Replacement; Knee Arthroplasty; Exercise; Arthritis; Rheumatic Disease