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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.
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| Name | Class |
|---|---|
| Istituto Nazionale di Ricovero e Cura per Anziani | OTHER |
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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.
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:
Traditional Rehabilitation (TR): the TR group exercises will be performed in the gym with a physiotherapist. In particular, patients will perform:
Traditional Hydrotherapy (TH): the TH group exercises will be performed in a swimming pool suitable for hydrotherapy treatments. In particular, patients will perform:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| 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:
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| Traditional Rehabilitation (TR) | Active Comparator | The TR group exercises will be performed in the gym with a physiotherapist. In particular, patients will perform:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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| 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. |
| 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. |
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The inclusion criteria are:
The exclusion criteria are:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Franceschini, MD | IRCCS San Raffaele | Study Chair |
| Sanaz Pournajaf, Dr | IRCCS San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffele | Rome | RM | 00166 | Italy |
The protocol for the study will be published shortly.
Soon.
Open Access
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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
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The care providers are not aware about the research study protocol.
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| Traditional Hydrotherapy (TH) | Procedure | The TH group exercises will be performed in a swimming pool suitable for hydrotherapy treatments. In particular, patients will perform:
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| Traditional Rehabilitation (TR) | Procedure | The TR group exercises will be performed in the gym with a physiotherapist. In particular, patients will perform:
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| D012216 |
| Rheumatic Diseases |