TKR Rehabilitation Through the Immersive Virtual Reality in Aquatic Scenarios

Summary

This study is a multicenter non-randomized single-blind controlled trial, aimed at investigating the feasibility and efficacy of hydrotherapy based on IVR, for the patients with TKR(Total Knee Replacement), on the function, gait performance, postural balance control, and knee edema reduction. The protocol was draft according to the Consolidated Standards of Reporting Trials (CONSORT ) checklists.

A total of 96patients with total knee prosthesis will be recruited and divided into three groups, to receive a traditional rehabilitation (TR) program, traditional hydrotherapy (TH)or hydrotherapy through immersive virtual reality (HIVR) using Bts-Nirvana. Assessments will be performed at baseline and at the end of treatment.

Conditions

• Knee Osteoarthritis
• Total Knee Replacement

Interventions

DEVICE

Experimental: Immersive Virtual Reality (HIVR)

the HIVR exercises will be performed using Nirvana system, a medical device based on virtual reality specifically designed to support motor rehabilitation, by projecting aquatic scenarios on the floor that simulates the movement and the noise of the water due to the motor exercise execution by the patient. In particular, the following virtual reality scenarios will be used: * "Swimming pool": the environment represents a swimming pool (water and edge). The patient must perform exercises by moving the lower limbs while sitting on a chair. The virtual environment gives the sensation of having the lower limbs immersed in water above the knees; * "Water metal": the environment gives the feeling of being immersed in water up to the waist. The subject interacts with the virtual water performing walking exercises and receiving a visual and auditory biofeedback.

PROCEDURE

Traditional Hydrotherapy (TH)

The TH group exercises will be performed in a swimming pool suitable for hydrotherapy treatments. In particular, patients will perform: * exercises with a patients sitting on the swimming pool edge with lower limb immersed in the water; * flexion-extension of the knee; * leg and hip circling; * flexion-extension of the ankle; * triple flexion; * water walking exercises.

PROCEDURE

Traditional Rehabilitation (TR)

The TR group exercises will be performed in the gym with a physiotherapist. In particular, patients will perform: * exercises with a patient sitting on a chair (3 minutes per exercise): * flexion-extension of the knee; * leg and hip circling; * flexion-extension of the ankle; * triple flexion; * walking (with and without aids).

Sponsors & Collaborators

• Istituto Nazionale di Ricovero e Cura per Anziani

  collaborator OTHER

• IRCCS San Raffaele Roma

  lead OTHER

Principal Investigators

• Marco Franceschini, MD · IRCCS San Raffaele

• Sanaz Pournajaf, Dr · IRCCS San Raffaele

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-02-20

Primary Completion

2025-07-30

Completion

2025-12-30

Countries

• Italy

Study Locations