Clinical trial NCT02413996: Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty
Official title: Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Replacement
Virtual Reality Therapy
Osteoarthritis
Knee Arthroplasty
Rehabilitation
Keywords: Virtual Reality Therapy
Rehabilitation
Total Knee Replacement
Knee Arthroplasty
Exercise
Arthritis
Rheumatic Disease
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2015-04-10
Enrollment: 85
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A phase III randomized clinical trial was approved by the San Raffaele Hospital's Ethic Committee of Milan (31/03/2014)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain: Visual Analogue Scale (VAS)
timeFrame: baseline and 10 days (value at day 10 minus value at baseline)
Secondary outcomes:
measure: Knee Disability: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Questionnaire
timeFrame: baseline and 10 days (value at day 10 minus value at baseline)
measure: Knee Active Range of Motion
timeFrame: assesed and reported at 10 days
measure: Health Related Quality of Life: Euro Quality of Life Five Dimensions Questionnaire (EQ-5D)
timeFrame: assessed and reported at 10 days
measure: Global Perceived Effect (GPE)
timeFrame: assessed and reported at 10 days
measure: The Functional Independence Measure (FIM) Scale
timeFrame: baseline and 10 days (value at day 10 minus value at baseline)
measure: Proprioception
timeFrame: assessed and reported at 10 day
measure: Isometric Strength of Quadriceps and Hamstrings
timeFrame: baseline and 10 days (value at day 10 minus value at baseline)
measure: Drugs Assumption
timeFrame: value at day 10
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Galeazzi Orthopedic Hospital
Study officials:
affiliation: IRCCS Galeazzi Hospital
name: Giuseppe Banfi, MD
role: STUDY_DIRECTOR
References:
citation: Gianola S, Stucovitz E, Castellini G, Mascali M, Vanni F, Tramacere I, Banfi G, Tornese D. Effects of early virtual reality-based rehabilitation in patients with total knee arthroplasty: A randomized controlled trial. Medicine (Baltimore). 2020 Feb;99(7):e19136. doi: 10.1097/MD.0000000000019136.