NCT02413996

Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Total Knee Replacement
• Virtual Reality Therapy
• Osteoarthritis
• Knee Arthroplasty
• Rehabilitation

Interventions

Type	Name	Description
DEVICE	Kinetec® knee continuous passive motion (CPM )	CPM of the knee
BEHAVIORAL	Functional activities	Stairs, walking
OTHER	VRRS rehabilitation	exercise therapy through a virtual reality rehabilitation system (VRRS)
OTHER	traditional rehabilitation	exercise therapy through a traditional rehabilitation training made by physiotherapists

Timeline

• Start date: 2014-09-01
• Primary completion: 2018-05-05
• Completion: 2018-05-25
• First posted: 2015-04-10
• Last updated: 2020-01-09
• Results posted: 2020-01-09

Locations

1 site across 1 country: Italy