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Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02413996
Recruitment Status : Completed
First Posted : April 10, 2015
Results First Posted : January 9, 2020
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Davide Tornese, Istituto Ortopedico Galeazzi

Study Description
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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).

Condition or disease Intervention/treatment Phase
Total Knee Replacement Virtual Reality Therapy Osteoarthritis Knee Arthroplasty Rehabilitation Device: Kinetec® knee continuous passive motion (CPM ) Behavioral: Functional activities Other: VRRS rehabilitation Other: traditional rehabilitation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A phase III randomized clinical trial was approved by the San Raffaele Hospital's Ethic Committee of Milan (31/03/2014)
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty: A Randomised Controlled Trial
Study Start Date : September 2014
Actual Primary Completion Date : May 5, 2018
Actual Study Completion Date : May 25, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02413996


Locations
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Italy
IRCCS Galeazzi Orthopedic Hospital
Milan, Italy, 20161
Sponsors and Collaborators
Istituto Ortopedico Galeazzi
Investigators
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Study Director: Giuseppe Banfi, MD IRCCS Galeazzi Hospital
  Study Documents (Full-Text)

Documents provided by Davide Tornese, Istituto Ortopedico Galeazzi:
Study Protocol and Statistical Analysis Plan  [PDF] March 6, 2014

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Davide Tornese, Medico Chirurgo Specialista in Medicina Fisica e Riabilitazione, Specialista in Medicina dello Sport, Responsabile reparto di Riabilitazione Sportiva, Istituto Ortopedico Galeazzi
ClinicalTrials.gov Identifier: NCT02413996    
Other Study ID Numbers: VRRS
First Posted: April 10, 2015    Key Record Dates
Results First Posted: January 9, 2020
Last Update Posted: January 9, 2020
Last Verified: December 2019
Keywords provided by Davide Tornese, Istituto Ortopedico Galeazzi:
Virtual Reality Therapy
Rehabilitation
Total Knee Replacement
Knee Arthroplasty
 Exercise
Arthritis
Rheumatic Disease
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases