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

April 9, 2024 updated by: IRCCS San Raffaele Roma

Effects of Virtual Reality Rehabilitation in Patients With Total Knee Replacement

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. 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.
  2. 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.
  3. Observing changes in neurophysiological patterns in the two groups.

Study Type

Interventional

Enrollment (Actual)

48

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
    • RM
      • Roma, RM, Italy, 00166
        • IRCCS San Raffaele Pisana

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

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality Group (VRG)
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.
Device: Virtual Reality
Virtual Reality Rehabilitation System
Other Names:
  • VRRS EVO, Khymeia s.r.l., Italy
No Intervention: Control Group (CG)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Time Up and Go (TUG)
Time Frame: Session 1 (baseline) and session 15 (day 21)
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.
Session 1 (baseline) and session 15 (day 21)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 10 Meter Walk Test (10-MWT)
Time Frame: Session 1 (baseline) and session 15 (day 21)
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.
Session 1 (baseline) and session 15 (day 21)
Change in Medical Research Council scale (MRC)
Time Frame: Session 1 (baseline) and session 15 (day 21)
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.
Session 1 (baseline) and session 15 (day 21)
Change in Visual Analog Scale (VAS)
Time Frame: Session 1 (baseline) and session 15 (day 21)
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.
Session 1 (baseline) and session 15 (day 21)
Change in Barthel Index (BI)
Time Frame: Session 1 (baseline) and session 15 (day 21)
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.
Session 1 (baseline) and session 15 (day 21)
MiniMental State evaluation (MMSE)
Time Frame: Session 1 (baseline)
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.
Session 1 (baseline)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait Analysis
Time Frame: Session 1 (baseline) and session 15 (day 21)
Kinematic and kinetic gait parameters will be calculated from data acquired with a motion capture system (SMART-DX; BTSBioengneering, Italy).
Session 1 (baseline) and session 15 (day 21)
Postural Analysis
Time Frame: Session 1 (baseline) and session 15 (day 21)
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.
Session 1 (baseline) and session 15 (day 21)

Collaborators and Investigators

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

Sponsor

IRCCS San Raffaele Roma

Investigators

  • Study Chair: Marco Franceschini, MD, IRCCS Sanraffaele Pisana

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 (Actual)

November 8, 2016

Primary Completion (Actual)

October 8, 2019

Study Completion (Actual)

November 13, 2019

Study Registration Dates

First Submitted

February 26, 2018

First Submitted That Met QC Criteria

March 2, 2018

First Posted (Actual)

March 5, 2018

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP 15/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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