Virtual Reality Rehabilitation in Patients With Total Knee Replacement

NCT ID: NCT03454256

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-08
• Study Completion Date: 2019-11-13

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.

Conditions

Knee Arthropathy; Total Knee Replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: DEVICE

Virtual Reality Rehabilitation System

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality

Virtual Reality Rehabilitation System

Intervention Type: DEVICE

Other Intervention Names

VRRS EVO, Khymeia s.r.l., Italy

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele Roma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco Franceschini, MD

Role: STUDY_CHAIR

IRCCS Sanraffaele Pisana

Locations

IRCCS San Raffaele Pisana

Roma, RM, Italy

Countries

Italy

References

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Reference Type: BACKGROUND

PMID: 21251988 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 22713539 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22898573 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 27149529 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25460343 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26336875 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10334686 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11097448 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34839056 (View on PubMed)

Other Identifiers

RP 15/16

Identifier Type: -

Identifier Source: org_study_id