Skip to main content
OpenTrials
Completed

NCT Number: NCT02413996

Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Total Knee Replacement Arthritis Behavior Connective Tissue Diseases Joint Diseases Knee Arthroplasty Motor Activity Musculoskeletal Diseases Osteoarthritis Rehabilitation Rheumatic Diseases Skin and Connective Tissue Diseases Virtual Reality Therapy

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Galeazzi Orthopedic Hospital

Milan, 20161, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kinetec® knee continuous passive motion (CPM )

Device

CPM of the knee

Functional activities

Behavioral

Stairs, walking

VRRS rehabilitation

Other

exercise therapy through a virtual reality rehabilitation system (VRRS)

traditional rehabilitation

Other

exercise therapy through a traditional rehabilitation training made by physiotherapists

Primary outcomes

  1. 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

  1. Knee Disability: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Questionnaire

    Time frame: baseline and 10 days (value at day 10 minus value at baseline)

    The WOMAC measures five items for pain (score range 0-500), two for stiffness (score range 0-200), and 17 for functional limitation (score range 0-1700) for a total score of 2400 (0= no disability, 2400= highest disability):

    • Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing
    • Stiffness (2 items): after first waking and later in the day
    • Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties

  2. Knee Active Range of Motion

    Time frame: assesed and reported at 10 days

    assessed by Virtual Reality Rehabilitation System (degree of movement)

  3. Health Related Quality of Life: Euro Quality of Life Five Dimensions Questionnaire (EQ-5D)

    Time frame: assessed and reported at 10 days

    The EQ-5D comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.The EQ-5D descriptive system is divided into five levels of perceived problems: LEVEL 1: indicating no problem; LEVEL 2:indicating some problems;LEVEL 3: indicating extreme problems. EQ-5D health states can be summarised using the 5-digit code (e.g., 11111, 12311).The answers given to ED-5D permit to find 243 5-digit codes defining the health states.The 5-digit code are linked to an unique index derived by applying a formula that attaches values (weights) to each of the levels in each dimension.Weights depend on the country (Italian Population-Based Values of EQ-5D HealthStates,Scalone 2013).The index has been calculated by deducting the appropriate weights from 1 which is the best health status as highest score (i.e. the corresponding 5-digit code is 11111) and -0.38 for the worst health status as minimum score (i.e., the corresponding 5-digit code is 33333).

  4. Global Perceived Effect (GPE)

    Time frame: assessed and reported at 10 days

    The GPE scale asks the patient to rate, on a numerical scale, how much their condition has improved or deteriorated since some predefined time point. The GPE was administered at the end of the physiotherapy treatment to measure the effect of the intervention on patients' health status perception. This Likert scale had five response options (5 = Very much improved; 4 = Much improved, 3 = No change, 2 = Much worse, 1 = Very much worse).

  5. The Functional Independence Measure (FIM) Scale

    Time frame: baseline and 10 days (value at day 10 minus value at baseline)

    The FIM scale assesses physical and cognitive disability focusing on the level of disability indicating the burden of caring for them. The total score is 126 (18=highest disability, 126=no disability).

  6. Proprioception

    Time frame: assessed and reported at 10 day

    assessed by Virtual Reality Rehabilitation System (percentage value of similarity between ideal and patient knee movement trajector)

  7. Isometric Strength of Quadriceps and Hamstrings

    Time frame: baseline and 10 days (value at day 10 minus value at baseline)

    Isometric strength of quadriceps and hamstrings is assessed by dynamometer (newton unit)

  8. Drugs Assumption

    Time frame: value at day 10

    number of drugs assumpted for each group during rehabilitation recovery

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 10, 2015
Registry last updated
Jan 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.