Knee OsteoarthritisHYDROKNEERVANANCT04241172
TKR Rehabilitation Through the Immersive Virtual Reality in Aquatic Scenarios
A study testing Experimental: Immersive Virtual Reality (HIVR), Traditional Hydrotherapy (TH) and Traditional Rehabilitation (TR) in people with Knee Osteoarthritis and Total Knee Replacement, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Knee Osteoarthritis, Total Knee Replacement
- What is being tested?
- Experimental: Immersive Virtual Reality (HIVR), Traditional Hydrotherapy (TH) and Traditional Rehabilitation (TR)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteItaly
- Study dates
- 20 Feb 2020to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis, Total Knee Replacement
- Being tested
- Experimental: Immersive Virtual Reality (HIVR), Traditional Hydrotherapy (TH), Traditional Rehabilitation (TR)
- Keywords
- Proprioceptive, Balance, Total Knee Replacement
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Traditional Hydrotherapy (TH)Procedure or surgery
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 Rehabilitation (TR)Procedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: Procedure: Traditional Rehabilitation (TR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
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
Measured: At baseline (day 1-T1) and at the end (day 21 -T2) of the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start20 Feb 2020
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Nazionale di Ricovero e Cura per Anziani
- Responsible party
- Sponsor
- Investigators
- Marco Franceschini, MD, Study chair, IRCCS San RaffaeleSanaz Pournajaf, Dr, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241172
- Sponsor's protocol ID
- RP 19/11
- Acronym
- HYDROKNEERVANA
- Status last verified
- Oct 2026
- First submitted
- 22 Jan 2020
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The protocol for the study will be published shortly.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Patients With Total Knee Replacement Through the Immersive Virtual Reality in Aquatic Scenarios
- ClinicalTrials.gov ID
- NCT04241172
- Acronym / sponsor ID
- HYDROKNEERVANA / RP 19/11
- Conditions
- Knee Osteoarthritis, Total Knee Replacement
- Keywords
- Proprioceptive, Balance, Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: 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.
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Collaborators
- Istituto Nazionale di Ricovero e Cura per Anziani
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Immersive Virtual Reality (HIVR) | Experimental | 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 visual and auditory biofeedback. |
| Traditional Hydrotherapy (TH) | Active comparator | 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 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 Rehabilitation (TR) | Active comparator | 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). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Immersive Virtual Reality (HIVR) |
| 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 or surgery | Traditional Hydrotherapy (TH) |
| 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 or surgery | Traditional Rehabilitation (TR) |
Primary outcome
Changes in Time Up & Go Test
Time frame: At baseline (day 1-T1) and at the end (day 21 -T2) of the treatment.
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
1 secondary outcome
Change in 10-Metre Walking Test (10MWT)
Time frame: At baseline (day 1-T1) and at the end (day 21 -T2) of the treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Yes. The protocol for the study will be published shortly.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Franceschini, MD study chair
IRCCS San Raffaele
Sanaz Pournajaf, Dr principal investigator
IRCCS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Immersive Virtual Reality (HIVR), Traditional Hydrotherapy (TH) and Traditional Rehabilitation (TR) in people with Knee Osteoarthritis and Total Knee Replacement, run by IRCCS San Raffaele Roma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Time Up & Go Test (time frame: At baseline (day 1-T1) and at the end (day 21 -T2) of the treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.