Virtual Reality Rehabilitation in Patients With Total Knee Replacement

Total Knee Replacement Clinical Trial

— VRRS_KNEE  

Official title:

Effects of Virtual Reality Rehabilitation in Patients With Total Knee Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03454256
• Other study ID #: RP 15/16
• Status: Completed
• Phase: N/A
• Start date: November 8, 2016
• Est. completion date: November 13, 2019

Study information

• Verified date: April 2024
• Source: IRCCS San Raffaele Roma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 13, 2019
• Est. primary completion date: October 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Knee Arthropathy
• Total Knee Replacement

Intervention

Device:
• Virtual Reality
Virtual Reality Rehabilitation System

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele Pisana	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele Roma

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gait Analysis	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)
Other	Postural Analysis	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)
Primary	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	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.	Session 1 (baseline) and session 15 (day 21)
Secondary	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.	Session 1 (baseline) and session 15 (day 21)
Secondary	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.	Session 1 (baseline) and session 15 (day 21)
Secondary	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.	Session 1 (baseline) and session 15 (day 21)
Secondary	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.	Session 1 (baseline)