Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty: A Randomised Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Total Knee Replacement
- Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- Pain: Visual Analogue Scale (VAS)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Davide Tornese
Medico Chirurgo Specialista in Medicina Fisica e Riabilitazione, Specialista in Medicina dello Sport, Responsabile reparto di Riabilitazione Sportiva
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Eligibility Criteria
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
Outcomes
Primary Outcomes
Pain: Visual Analogue Scale (VAS)
Time Frame: baseline and 10 days (value at day 10 minus value at baseline)
The VAS scale was measured in a range of 0-100 cm (0 no pain and 100 the worst pain)
Secondary Outcomes
- The Functional Independence Measure (FIM) Scale(baseline and 10 days (value at day 10 minus value at baseline))
- Knee Disability: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Questionnaire(baseline and 10 days (value at day 10 minus value at baseline))
- Knee Active Range of Motion(assesed and reported at 10 days)
- Health Related Quality of Life: Euro Quality of Life Five Dimensions Questionnaire (EQ-5D)(assessed and reported at 10 days)
- Global Perceived Effect (GPE)(assessed and reported at 10 days)
- Proprioception(assessed and reported at 10 day)
- Isometric Strength of Quadriceps and Hamstrings(baseline and 10 days (value at day 10 minus value at baseline))
- Drugs Assumption(value at day 10)