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Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty

Primary Purpose

Total Knee Replacement, Virtual Reality Therapy, Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Kinetec® knee continuous passive motion (CPM )
Functional activities
VRRS rehabilitation
traditional rehabilitation
Sponsored by
Istituto Ortopedico Galeazzi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Knee Replacement focused on measuring Virtual Reality Therapy, Rehabilitation, Total Knee Replacement, Knee Arthroplasty, Exercise, Arthritis, Rheumatic Disease

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • IRCCS Galeazzi Orthopedic Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VRRS rehabilitation

traditional rehabilitation

Arm 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)

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)

Outcomes

Primary Outcome Measures

Pain: Visual Analogue Scale (VAS)
The VAS scale was measured in a range of 0-100 cm (0 no pain and 100 the worst pain)

Secondary Outcome Measures

Knee Disability: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Questionnaire
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
Knee Active Range of Motion
assessed by Virtual Reality Rehabilitation System (degree of movement)
Health Related Quality of Life: Euro Quality of Life Five Dimensions Questionnaire (EQ-5D)
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).
Global Perceived Effect (GPE)
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).
The Functional Independence Measure (FIM) Scale
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).
Proprioception
assessed by Virtual Reality Rehabilitation System (percentage value of similarity between ideal and patient knee movement trajector)
Isometric Strength of Quadriceps and Hamstrings
Isometric strength of quadriceps and hamstrings is assessed by dynamometer (newton unit)
Drugs Assumption
number of drugs assumpted for each group during rehabilitation recovery

Full Information

First Posted
March 11, 2015
Last Updated
December 19, 2019
Sponsor
Istituto Ortopedico Galeazzi
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1. Study Identification

Unique Protocol Identification Number
NCT02413996
Brief Title
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

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 5, 2018 (Actual)
Study Completion Date
May 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Ortopedico Galeazzi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Replacement, Virtual Reality Therapy, Osteoarthritis, Knee Arthroplasty, Rehabilitation
Keywords
Virtual Reality Therapy, Rehabilitation, Total Knee Replacement, Knee Arthroplasty, Exercise, Arthritis, Rheumatic Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A phase III randomized clinical trial was approved by the San Raffaele Hospital's Ethic Committee of Milan (31/03/2014)
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VRRS rehabilitation
Arm Type
Experimental
Arm 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)
Arm Title
traditional rehabilitation
Arm Type
Active Comparator
Arm 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)
Intervention Type
Device
Intervention Name(s)
Kinetec® knee continuous passive motion (CPM )
Intervention Description
CPM of the knee
Intervention Type
Behavioral
Intervention Name(s)
Functional activities
Intervention Description
Stairs, walking
Intervention Type
Other
Intervention Name(s)
VRRS rehabilitation
Intervention Description
exercise therapy through a virtual reality rehabilitation system (VRRS)
Intervention Type
Other
Intervention Name(s)
traditional rehabilitation
Intervention Description
exercise therapy through a traditional rehabilitation training made by physiotherapists
Primary Outcome Measure Information:
Title
Pain: Visual Analogue Scale (VAS)
Description
The VAS scale was measured in a range of 0-100 cm (0 no pain and 100 the worst pain)
Time Frame
baseline and 10 days (value at day 10 minus value at baseline)
Secondary Outcome Measure Information:
Title
Knee Disability: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Questionnaire
Description
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
Time Frame
baseline and 10 days (value at day 10 minus value at baseline)
Title
Knee Active Range of Motion
Description
assessed by Virtual Reality Rehabilitation System (degree of movement)
Time Frame
assesed and reported at 10 days
Title
Health Related Quality of Life: Euro Quality of Life Five Dimensions Questionnaire (EQ-5D)
Description
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).
Time Frame
assessed and reported at 10 days
Title
Global Perceived Effect (GPE)
Description
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).
Time Frame
assessed and reported at 10 days
Title
The Functional Independence Measure (FIM) Scale
Description
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).
Time Frame
baseline and 10 days (value at day 10 minus value at baseline)
Title
Proprioception
Description
assessed by Virtual Reality Rehabilitation System (percentage value of similarity between ideal and patient knee movement trajector)
Time Frame
assessed and reported at 10 day
Title
Isometric Strength of Quadriceps and Hamstrings
Description
Isometric strength of quadriceps and hamstrings is assessed by dynamometer (newton unit)
Time Frame
baseline and 10 days (value at day 10 minus value at baseline)
Title
Drugs Assumption
Description
number of drugs assumpted for each group during rehabilitation recovery
Time Frame
value at day 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Banfi, MD
Organizational Affiliation
IRCCS Galeazzi Hospital
Official's Role
Study Director
Facility Information:
Facility Name
IRCCS Galeazzi Orthopedic Hospital
City
Milan
ZIP/Postal Code
20161
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
32049833
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.
Results Reference
derived

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Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty

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