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Virtual Reality Rehabilitation in Patients With Total Knee Replacement (VRRS_KNEE)

Primary Purpose

Knee Arthropathy, Total Knee Replacement

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
IRCCS San Raffaele Roma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Arthropathy focused on measuring Virtual Reality, Total Knee Replacement, Proprioception, Balance, Gait

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • recruitment and initial assessment within 10 days of surgery;
  • monolateral knee arthroplasty in election;
  • collaborating patients who are able to perform the proposed exercise;
  • good cardiovascular compensation;
  • cognitively intact;
  • able to provide informed consent;

Exclusion Criteria:

  • no severe cognitive / behavioral deficit;
  • refusal or inability to provide informed consent;
  • presence of sever cardiorespiratory co-morbidities;
  • peripheral and /or central neurological deficits;
  • visual deficits;
  • presence of serious osteo-arthro-muscular diseases at controlateral lower limb against the prosthetic side;
  • complication at surgical wound

Sites / Locations

  • IRCCS San Raffaele Pisana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality Group (VRG)

Control Group (CG)

Arm Description

The Virtual Reality Group (VRG) will perform the rehabilitation trough the Virtual Reality Rehabilitation system (VRRS, Khymeia,Italy). The patient standing upright on a balance board will practice exercises of vertical position control with a visual biofeedback received from the VRRS and interacting with the serious video-games. The difficulty level of the exercises will increase gradually session by session. Every session will last 45 minutes with a frequency of at least 5 times a week.

The Control Group (CG) will perform the traditional treatment consisting of the exercises of rehabilitation of gait and postural passages, exercises for postural control, and proprioceptive exercises in a vertical position according to the method chosen by the physiotherapist. Every session will last 45 minutes with a frequency of at least 5 times a week.

Outcomes

Primary Outcome Measures

Change in Time Up and Go (TUG)
The TUG is a timed test used to assess mobility, balance, and walking in people with balance impairments. The subject must stand up from a chair (which should not be leaned up against a wall), walk a distance of 3 meters, turn around, walk back to the chair and sit down - all performed as quickly and as safely as possible.

Secondary Outcome Measures

Change in 10 Meter Walk Test (10-MWT)
The 10-MWT examine the patient's gait speed. Patients will be directed to walk at their preferred maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 second). The test will be recorded 3 times, with adequate rest in between. The average of the 3 times should be recorded.
Change in Medical Research Council scale (MRC)
The MRC will be used to evaluate the muscle strength of Quadriceps Femoris (QF) and Tibialis Anterior (TA). The muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle.
Change in Visual Analog Scale (VAS)
VAS is a 0-10 rating scale for pain which is used to gain a subjective report of the intensity of a person's pain. Zero represents "no pain" and ten represents "the most intense pain imaginable". A meaningful change would be plus or minus 3 points.
Change in Barthel Index (BI)
The BI is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. It uses ten variables describing ADL and mobility. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital.
MiniMental State evaluation (MMSE)
The MMSE (Folstein et al., 1975), is a 30-point questionnaire that is used extensively in clinical and research settings to measure intellectual efficiency disorder as well as cognitive impairment.

Full Information

First Posted
February 26, 2018
Last Updated
June 23, 2023
Sponsor
IRCCS San Raffaele Roma
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1. Study Identification

Unique Protocol Identification Number
NCT03454256
Brief Title
Virtual Reality Rehabilitation in Patients With Total Knee Replacement
Acronym
VRRS_KNEE
Official Title
Effects of Virtual Reality Rehabilitation in Patients With Total Knee Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 8, 2016 (Actual)
Primary Completion Date
October 8, 2019 (Actual)
Study Completion Date
November 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele Roma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Impaired proprioceptive accuracy could be a risk factor for progression of gait limitations in knee osteoarthritis patients, even after the Total Knee Replacement (TKR). Recent studies on Virtual Reality (VR) in rehabilitation show its efficacy in restoring proprioceptive capacity, postural control and gait. However, literature lacks such studies in TKR patients. This preliminary study aims to evaluate the efficacy of a VR system for the enhancement of motor skills in TKR patients compared to a traditional approach of rehabilitation.
Detailed Description
In this randomized controlled trial (RCT), the randomization of the sample will be performed by a local software and in a single blind design. Forty patients will be enrolled and after giving the informed consent, assigned to two groups : the experimental group (VRG), which will be undergone to treatment with virtual reality for the recovery of load distribution and proper gait pattern; the control group (CG), which will be undergone to a traditional rehabilitation addressed to recovery of correct gait pattern for the same time period as VRG. Both treatments consist in 15 sessions, at least 5 per week , each lasting 45 minutes. Both VRG or CG will last for 21 days from the start of treatment. All patients, in adjunction to Virtual Reality Rehabilitation (EG) or Traditional Rehabilitation (CG), will execute a global rehabilitation project, consisting in Physiotherapy, Physical Therapies for pain and inflammation control, and Occupational Therapy, personalized by a multidisciplinary rehabilitation team for a minimum of 150-180 minutes per day, and according to their clinical conditions for them. The purposes of this study in detail are: Observing differences in the distribution of the bi-podalic load in the group that performs a re-education with virtual reality compared to those who perform the traditional treatment. Observing differences in the recovery time of a correct pattern of gait in the group that performs a re-education with virtual reality compared to those who perform a traditional treatment. Observing changes in neurophysiological patterns in the two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthropathy, Total Knee Replacement
Keywords
Virtual Reality, Total Knee Replacement, Proprioception, Balance, Gait

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Group (VRG)
Arm Type
Experimental
Arm Description
The Virtual Reality Group (VRG) will perform the rehabilitation trough the Virtual Reality Rehabilitation system (VRRS, Khymeia,Italy). The patient standing upright on a balance board will practice exercises of vertical position control with a visual biofeedback received from the VRRS and interacting with the serious video-games. The difficulty level of the exercises will increase gradually session by session. Every session will last 45 minutes with a frequency of at least 5 times a week.
Arm Title
Control Group (CG)
Arm Type
No Intervention
Arm Description
The Control Group (CG) will perform the traditional treatment consisting of the exercises of rehabilitation of gait and postural passages, exercises for postural control, and proprioceptive exercises in a vertical position according to the method chosen by the physiotherapist. Every session will last 45 minutes with a frequency of at least 5 times a week.
Intervention Type
Device
Intervention Name(s)
Virtual Reality
Other Intervention Name(s)
VRRS EVO, Khymeia s.r.l., Italy
Intervention Description
Virtual Reality Rehabilitation System
Primary Outcome Measure Information:
Title
Change in Time Up and Go (TUG)
Description
The TUG is a timed test used to assess mobility, balance, and walking in people with balance impairments. The subject must stand up from a chair (which should not be leaned up against a wall), walk a distance of 3 meters, turn around, walk back to the chair and sit down - all performed as quickly and as safely as possible.
Time Frame
Session 1 (baseline) and session 15 (day 21)
Secondary Outcome Measure Information:
Title
Change in 10 Meter Walk Test (10-MWT)
Description
The 10-MWT examine the patient's gait speed. Patients will be directed to walk at their preferred maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 second). The test will be recorded 3 times, with adequate rest in between. The average of the 3 times should be recorded.
Time Frame
Session 1 (baseline) and session 15 (day 21)
Title
Change in Medical Research Council scale (MRC)
Description
The MRC will be used to evaluate the muscle strength of Quadriceps Femoris (QF) and Tibialis Anterior (TA). The muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle.
Time Frame
Session 1 (baseline) and session 15 (day 21)
Title
Change in Visual Analog Scale (VAS)
Description
VAS is a 0-10 rating scale for pain which is used to gain a subjective report of the intensity of a person's pain. Zero represents "no pain" and ten represents "the most intense pain imaginable". A meaningful change would be plus or minus 3 points.
Time Frame
Session 1 (baseline) and session 15 (day 21)
Title
Change in Barthel Index (BI)
Description
The BI is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. It uses ten variables describing ADL and mobility. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital.
Time Frame
Session 1 (baseline) and session 15 (day 21)
Title
MiniMental State evaluation (MMSE)
Description
The MMSE (Folstein et al., 1975), is a 30-point questionnaire that is used extensively in clinical and research settings to measure intellectual efficiency disorder as well as cognitive impairment.
Time Frame
Session 1 (baseline)
Other Pre-specified Outcome Measures:
Title
Gait Analysis
Description
Kinematic and kinetic gait parameters will be calculated from data acquired with a motion capture system (SMART-DX; BTSBioengneering, Italy).
Time Frame
Session 1 (baseline) and session 15 (day 21)
Title
Postural Analysis
Description
Posturographic parameters will be obtained from the analysis of the center of pressure (COP) trajectories measured by force platforms during standing in both open and closed eyes conditions.
Time Frame
Session 1 (baseline) and session 15 (day 21)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: recruitment and initial assessment within 10 days of surgery; monolateral knee arthroplasty in election; collaborating patients who are able to perform the proposed exercise; good cardiovascular compensation; cognitively intact; able to provide informed consent; Exclusion Criteria: no severe cognitive / behavioral deficit; refusal or inability to provide informed consent; presence of sever cardiorespiratory co-morbidities; peripheral and /or central neurological deficits; visual deficits; presence of serious osteo-arthro-muscular diseases at controlateral lower limb against the prosthetic side; complication at surgical wound
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Franceschini, MD
Organizational Affiliation
IRCCS Sanraffaele Pisana
Official's Role
Study Chair
Facility Information:
Facility Name
IRCCS San Raffaele Pisana
City
Roma
State/Province
RM
ZIP/Postal Code
00166
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21251988
Citation
Knoop J, Steultjens MP, van der Leeden M, van der Esch M, Thorstensson CA, Roorda LD, Lems WF, Dekker J. Proprioception in knee osteoarthritis: a narrative review. Osteoarthritis Cartilage. 2011 Apr;19(4):381-8. doi: 10.1016/j.joca.2011.01.003. Epub 2011 Jan 18.
Results Reference
background
PubMed Identifier
22713539
Citation
Laver K, George S, Thomas S, Deutsch JE, Crotty M. Cochrane review: virtual reality for stroke rehabilitation. Eur J Phys Rehabil Med. 2012 Sep;48(3):523-30. Epub 2012 Jun 20.
Results Reference
background
PubMed Identifier
22898573
Citation
Fung V, Ho A, Shaffer J, Chung E, Gomez M. Use of Nintendo Wii Fit in the rehabilitation of outpatients following total knee replacement: a preliminary randomised controlled trial. Physiotherapy. 2012 Sep;98(3):183-8. doi: 10.1016/j.physio.2012.04.001. Epub 2012 Jul 10.
Results Reference
background
PubMed Identifier
27149529
Citation
Lee M, Suh D, Son J, Kim J, Eun SD, Yoon B. Patient perspectives on virtual reality-based rehabilitation after knee surgery: Importance of level of difficulty. J Rehabil Res Dev. 2016;53(2):239-52. doi: 10.1682/JRRD.2014.07.0164.
Results Reference
background
PubMed Identifier
25460343
Citation
Negus JJ, Cawthorne DP, Chen JS, Scholes CJ, Parker DA, March LM. Patient outcomes using Wii-enhanced rehabilitation after total knee replacement - the TKR-POWER study. Contemp Clin Trials. 2015 Jan;40:47-53. doi: 10.1016/j.cct.2014.11.007. Epub 2014 Nov 12.
Results Reference
background
PubMed Identifier
26336875
Citation
Levinger P, Zeina D, Teshome AK, Skinner E, Begg R, Abbott JH. A real time biofeedback using Kinect and Wii to improve gait for post-total knee replacement rehabilitation: a case study report. Disabil Rehabil Assist Technol. 2016;11(3):251-62. doi: 10.3109/17483107.2015.1080767. Epub 2015 Sep 4.
Results Reference
background
PubMed Identifier
10334686
Citation
Dieppe P, Basler HD, Chard J, Croft P, Dixon J, Hurley M, Lohmander S, Raspe H. Knee replacement surgery for osteoarthritis: effectiveness, practice variations, indications and possible determinants of utilization. Rheumatology (Oxford). 1999 Jan;38(1):73-83. doi: 10.1093/rheumatology/38.1.73. No abstract available.
Results Reference
background
PubMed Identifier
11097448
Citation
Koralewicz LM, Engh GA. Comparison of proprioception in arthritic and age-matched normal knees. J Bone Joint Surg Am. 2000 Nov;82(11):1582-8. doi: 10.2106/00004623-200011000-00011.
Results Reference
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PubMed Identifier
34839056
Citation
Pournajaf S, Goffredo M, Pellicciari L, Piscitelli D, Criscuolo S, Le Pera D, Damiani C, Franceschini M. Effect of balance training using virtual reality-based serious games in individuals with total knee replacement: A randomized controlled trial. Ann Phys Rehabil Med. 2022 Nov;65(6):101609. doi: 10.1016/j.rehab.2021.101609. Epub 2022 Sep 29.
Results Reference
derived

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Virtual Reality Rehabilitation in Patients With Total Knee Replacement

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