TKR Rehabilitation Through the Immersive Virtual Reality in Aquatic Scenarios

NCT04241172 | Suspended DMC

• 1 other identifier: RP 19/11
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Proprioceptive; Balance; Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in 10-Metre Walking Test (10MWT)

  At baseline (day 1-T1) and at the end (day 21 -T2) of the treatment.

Study Arms (3)

Immersive Virtual Reality (HIVR)

EXPERIMENTAL

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)

Traditional Hydrotherapy (TH)

ACTIVE COMPARATOR

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)

Traditional Rehabilitation (TR)

ACTIVE COMPARATOR

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)

Interventions

Experimental: Immersive Virtual Reality (HIVR) DEVICE

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.

Immersive Virtual Reality (HIVR)

Traditional Hydrotherapy (TH) PROCEDURE

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.

Traditional Hydrotherapy (TH)

Traditional Rehabilitation (TR) PROCEDURE

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 Rehabilitation (TR)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead
• Istituto Nazionale di Ricovero e Cura per Anziani: collaborator

Study Sites (1)

IRCCS San Raffele

Rome, RM, 00166, Italy

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Marco Franceschini, MD

  IRCCS San Raffaele

  STUDY CHAIR

• Sanaz Pournajaf, Dr

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The care providers are not aware about the research study protocol.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: patients with total knee prosthesis divided into three groups, to receive a traditional rehabilitation (TR) program, traditional hydrotherapy (TH) or hydrotherapy through immersive virtual reality (HIVR) using Bts-Nirvana

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 27, 2020
• Study Start: February 20, 2020
• Primary Completion: July 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Soon.
• Access Criteria: Open Access

Locations

IT (1)