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SUSPENDED
NCT04241172
NA

TKR Rehabilitation Through the Immersive Virtual Reality in Aquatic Scenarios

Sponsor: IRCCS San Raffaele Roma

View on ClinicalTrials.gov

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.

Official title: Rehabilitation of Patients With Total Knee Replacement Through the Immersive Virtual Reality in Aquatic Scenarios

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2020-02-20

Completion Date

2026-11-30

Last Updated

2026-10-19

Healthy Volunteers

No

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).

Locations (1)

IRCCS San Raffele

Rome, RM, Italy