Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty

December 19, 2019 updated by: Davide Tornese, Istituto Ortopedico Galeazzi

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20161
        • IRCCS Galeazzi Orthopedic Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: VRRS rehabilitation
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)
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)
ACTIVE_COMPARATOR: traditional rehabilitation
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)
Device: Kinetec® knee continuous passive motion (CPM )
CPM of the knee
Behavioral: Functional activities
Stairs, walking
Other: traditional rehabilitation
exercise therapy through a traditional rehabilitation training made by physiotherapists

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
baseline and 10 days (value at day 10 minus value at baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline and 10 days (value at day 10 minus value at baseline)
Knee Active Range of Motion
Time Frame: assesed and reported at 10 days
assessed by Virtual Reality Rehabilitation System (degree of movement)
assesed and reported at 10 days
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).
assessed and reported at 10 days
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).
assessed and reported at 10 days
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).
baseline and 10 days (value at day 10 minus value at baseline)
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)
assessed and reported at 10 day
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)
baseline and 10 days (value at day 10 minus value at baseline)
Drugs Assumption
Time Frame: value at day 10
number of drugs assumpted for each group during rehabilitation recovery
value at day 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Galeazzi

Investigators

  • Study Director: Giuseppe Banfi, MD, IRCCS Galeazzi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ACTUAL)

May 5, 2018

Study Completion (ACTUAL)

May 25, 2018

Study Registration Dates

First Submitted

March 11, 2015

First Submitted That Met QC Criteria

April 7, 2015

First Posted (ESTIMATE)

April 10, 2015

Study Record Updates

Last Update Posted (ACTUAL)

January 9, 2020

Last Update Submitted That Met QC Criteria

December 19, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VRRS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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