Clinical trial NCT03454256: Virtual Reality Rehabilitation in Patients With Total Knee Replacement
Official title: Effects of Virtual Reality Rehabilitation in Patients With Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthropathy
Total Knee Replacement
Keywords: Virtual Reality
Total Knee Replacement
Proprioception
Balance
Gait
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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

Primary outcomes:
measure: Change in Time Up and Go (TUG)
timeFrame: Session 1 (baseline) and session 15 (day 21)
Secondary outcomes:
measure: Change in 10 Meter Walk Test (10-MWT)
timeFrame: Session 1 (baseline) and session 15 (day 21)
measure: Change in Medical Research Council scale (MRC)
timeFrame: Session 1 (baseline) and session 15 (day 21)
measure: Change in Visual Analog Scale (VAS)
timeFrame: Session 1 (baseline) and session 15 (day 21)
measure: Change in Barthel Index (BI)
timeFrame: Session 1 (baseline) and session 15 (day 21)
measure: MiniMental State evaluation (MMSE)
timeFrame: Session 1 (baseline)
Other outcomes:
measure: Gait Analysis
timeFrame: Session 1 (baseline) and session 15 (day 21)
measure: Postural Analysis
timeFrame: Session 1 (baseline) and session 15 (day 21)
Locations:
city: Roma
country: Italy
facility: IRCCS San Raffaele Pisana
state: RM
Study officials:
affiliation: IRCCS Sanraffaele Pisana
name: Marco Franceschini, MD
role: STUDY_CHAIR
References:
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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.
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.
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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.