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

IRCCS San Raffaele Roma

Status: Completed

Conditions: Total Knee Replacement; Knee Arthropathy

Treatments: Device: Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT03454256

RP 15/16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Virtual Reality Group (VRG)

Experimental group

Description:

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.

Treatment:

Device: Virtual Reality

Control Group (CG)

No Intervention group

Description:

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.