TKR Rehabilitation Through the Immersive Virtual Reality in Aquatic Scenarios (HYDROKNEERVANA)

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

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.

Study Overview

• Status: Suspended
• Conditions: Knee Osteoarthritis; Total Knee Replacement
• Intervention / Treatment: Device: Experimental: Immersive Virtual Reality (HIVR); Procedure: Traditional Hydrotherapy (TH); Procedure: Traditional Rehabilitation (TR)

Detailed Description

For the study, inpatients will be taken into consideration. A maximum of 17 treatment sessions will be conducted, divided from 3 to 5 training sessions per week. The treatments will be carried out in groups consisting of 3 patients.

All patients included in the study will perform 45 minutes of traditional rehabilitation treatments, consisted in:

• passive mobilization for the recovery of the complete articular range;
• active work on cycle ergometer;
• muscle strengthening with isometric and isotonic exercises;
• proprioceptive exercises in standing position for load balancing and balance control;
• step training with progressive reduction of walking aids;
• recovery of autonomy in the ascent and descent from the stairs;
• recovery of autonomy in daily life activities. In addition to this common program, specific knee therapy will be performed as provided in the three groups.

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).

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 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.

Hydrotherapy through 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 visual and auditory biofeedback.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • RM
    • Rome, RM, Italy, 00166
      • IRCCS San Raffele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

The inclusion criteria are:

• Aged ≤ 85;
• Capacity to consent and to perform the exercises of the specific protocol;
• Patients with total knee prosthesis.

The exclusion criteria are:

• Failure to meet the inclusion criteria;
• Concomitant participation in other studies;
• Unicompartmental knee prostheses;
• Surgery without drainage;
• Wound complications;
• Cognitive disorders;
• Diagnosis of epilepsy;
• Lack of written informed consent;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 visual and auditory biofeedback.	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.
Active Comparator: 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 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 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.
Active Comparator: 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).	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Time Up & Go Test	Time Up and Go test (TUG): TUG is a test used to determine fall risk and measure the progress of balance, sit to stand and walking. The patient starts in a seated position, then stands up, walks 3 meters, turns around, walks back to the chair and sits down. If a patient took 14 seconds or longer to perform the test he was classified as high-risk for falling	At baseline (day 1-T1) and at the end (day 21 -T2) of the treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 10-Metre Walking Test (10MWT)	10MWT is used to measure the time (and if required the number of steps) taken for subjects to cover a distance of ten meters from a standing start, when walking at their usual speed, as a measure of the change in aspects of their gait performance	At baseline (day 1-T1) and at the end (day 21 -T2) of the treatment.

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele Roma
• Collaborators: Istituto Nazionale di Ricovero e Cura per Anziani
• Investigators: Study Chair: Marco Franceschini, MD, IRCCS San Raffaele; Principal Investigator: Sanaz Pournajaf, Dr, IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2020
• Primary Completion (Estimated): July 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 24, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Balance; Total Knee Replacement; Proprioceptive
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: RP 19/11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The protocol for the study will be published shortly.
• IPD Sharing Time Frame: Soon.
• IPD Sharing Access Criteria: Open Access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No