NCT03454256

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2019

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

2.9 years

First QC Date

February 26, 2018

Last Update Submit

April 9, 2024

Conditions

Knee ArthropathyTotal Knee Replacement

Keywords

Virtual RealityTotal Knee ReplacementProprioceptionBalanceGait

Outcome Measures

Primary Outcomes (1)

  • 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.

    Session 1 (baseline) and session 15 (day 21)

Secondary Outcomes (5)

  • Change in 10 Meter Walk Test (10-MWT)

    Session 1 (baseline) and session 15 (day 21)

  • Change in Medical Research Council scale (MRC)

    Session 1 (baseline) and session 15 (day 21)

  • Change in Visual Analog Scale (VAS)

    Session 1 (baseline) and session 15 (day 21)

  • Change in Barthel Index (BI)

    Session 1 (baseline) and session 15 (day 21)

  • MiniMental State evaluation (MMSE)

    Session 1 (baseline)

Other Outcomes (2)

  • Gait Analysis

    Session 1 (baseline) and session 15 (day 21)

  • Postural Analysis

    Session 1 (baseline) and session 15 (day 21)

Study Arms (2)

Virtual Reality Group (VRG)

EXPERIMENTAL

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

Control Group (CG)

NO INTERVENTION

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.

Interventions

Virtual RealityDEVICE

Virtual Reality Rehabilitation System

Also known as: VRRS EVO, Khymeia s.r.l., Italy
Virtual Reality Group (VRG)

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Raffaele Pisana

Roma, RM, 00166, Italy

Location

Related Publications (9)

  • 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.

    PMID: 21251988BACKGROUND

  • 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.

    PMID: 22713539BACKGROUND

  • 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.

    PMID: 22898573BACKGROUND

  • 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.

    PMID: 27149529BACKGROUND

  • 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.

    PMID: 25460343BACKGROUND

  • 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.

    PMID: 26336875BACKGROUND

  • 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.

    PMID: 10334686BACKGROUND

  • 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.

    PMID: 11097448BACKGROUND

  • 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.

    PMID: 34839056DERIVED

Study Officials

  • Marco Franceschini, MD

    IRCCS Sanraffaele Pisana

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2018

First Posted

March 5, 2018

Study Start

November 8, 2016

Primary Completion

October 8, 2019

Study Completion

November 13, 2019

Last Updated

April 10, 2024

Record last verified: 2024-04

Locations

IT(1)