Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Status: Completed

Conditions: Knee Arthroplasty; Rehabilitation; Virtual Reality Therapy; Osteoarthritis; Total Knee Replacement

Treatments: Other: VRRS rehabilitation; Behavioral: Functional activities; Other: traditional rehabilitation; Device: Kinetec® knee continuous passive motion (CPM )

Study type: Interventional

Funder types: Other

Identifiers

NCT02413996

VRRS

Details and patient eligibility

About

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).

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

85 participants in 2 patient groups

VRRS rehabilitation

Experimental group

Description:

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)

Treatment:

Device: Kinetec® knee continuous passive motion (CPM )

Other: VRRS rehabilitation

Behavioral: Functional activities

traditional rehabilitation

Active Comparator group

Description:

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)

Treatment:

Device: Kinetec® knee continuous passive motion (CPM )

Other: traditional rehabilitation

Behavioral: Functional activities