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TKR Rehabilitation Through the Immersive Virtual Reality in Aquatic Scenarios

Reason given: Due to technical issues with the necessary facilities at the participating centers, the PIs have decided to suspend the study until the devices and hydrotherapy pool are fully operational.

This trial has no sites in United States.

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Trial details

Who runs it
IRCCS San Raffaele Roma
Trial code
NCT04241172
Record updated
19 October 2026
Original description
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.Read full original descriptionShow less

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.

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.

ClinicalTrials.gov NCT04241172