Osteoarthritis, HipNCT04221425
Early Virtual Reality Based Home Rehabilitation Program After Total Hip Arthroplasty
A study testing virtual reality rehabilitation system (VRRS) in people with Osteoarthritis, Hip, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
Total hip replacement (THR) is one of the most common interventions in orthopedic surgery. Rehabilitation is essential for maximizing the effectiveness of the surgery. Tele-rehabilitation programs after orthopedic surgery have proven their effectiveness, validity and cost-efficacy. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- virtual reality rehabilitation system (VRRS)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2019to 16 Feb 2021
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- males and females from 50 to 70 years old
- patients undergoing total hip arthroplasty with Anterior Minimally Invasive Surgery (AMIS)
- Body Mass Index ≤ 31
- Schooling: Lower secondary certificate
- Home internet connection
- Caregiver presence
- Domiciled in the conurbation of Milan
- Written informed consent and consent to all phases of the study
Who cannot join
- congenital or post traumatic morphological abnormalities
- presence of neurological conditions or cancer
- presence of implanted devices subjected to electromagnetic interference
- epilepsy
- informed refusal
- Ongoing anticoagulant or immunosuppressive therapies before surgery
- Self reported pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Recovery Evaluation Following Total Hip Arthroplasty And Early Home Rehabilitation Program With A Virtual Reality Based Rehabilitation System
Total hip replacement (THR) is one of the most common interventions in orthopedic surgery.
Rehabilitation is essential for maximizing the effectiveness of the surgery. Tele-rehabilitation programs after orthopedic surgery have proven their effectiveness, validity and cost-efficacy.
It seems of interest to test the potential advantages of early virtual reality based rehabilitation programs after total hip arthroplasty compared to standard care. The aim of the study is to evaluate the functional recovery following total hip arthroplasty and home telerehabilitation programs with a virtual reality based system.
- Conditions
- Osteoarthritis, Hip
- Being tested
- virtual reality rehabilitation system (VRRS), standard care
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality rehabilitation system (VRRS)Procedure or surgery
experimental group is equipped with a telerehabilitation system which comprises a tablet (VRRS tablet) and a set of inertial magnetic sensors. participants are invited to follow a daily rehabilitation exercise program provided via VRRS tablet
standard careProcedure or surgery
participants in the control group are invited to follow a daily rehabilitation exercise program and indications for the recovery as illustrated in the dimission booklets drawn up by the rehabilitation unit
| Study group | Role | What they receive |
|---|---|---|
| VRRS GROUP | Experimental | Home rehabilitation program is provided through a virtual reality based telerehabilitation system Receives: Procedure: virtual reality rehabilitation system (VRRS) |
| CONTROL GROUP | Active comparator | Home rehabilitation program is provided through illustrative booklet containing characteristics of exercises and indications for recovery Receives: Procedure: standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
the HOOS JR scale scores ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health
Measured: 15 ± 1 days after the surgery (T3)
Secondary outcomes (4)
Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
the HOOS JR scale scores ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health
Measured: baseline (before surgery (T0)), 4 ± 1 days after the surgery (T1), 7 ± 2 days after the surgery (T2)
BARTHEL INDEX (BI)
the BI assesses the ability of an individual to care for him/herself. Its scores ranges from 0 to 100, where 100 represents complete independence
Measured: baseline (before surgery (T0)), 4 ± 1 days after the surgery (T1), 15 ± 1 days after the surgery (T3)
Functional Independence Measure (FIM)
The Functional Independence Measure (FIM) explores an individual's physical, psychological and social function. Its scores ranges from 18 (lowest) to 126 (highest)
Measured: baseline (before surgery (T0)), 4 ± 1 days after the surgery (T1), 15 ± 1 days after the surgery (T3)
Global Perceived Effect (GPE)
The GPE scale asks the patient to rate, on a numerical scale from 1 to 5, where lower scores correspond to worse perceived effect, how much has the treatment received helped
Measured: 15 ± 1 days after the surgery (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start1 Mar 2019
- Primary completion16 Feb 2021
- Study completion16 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, HipStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GIUSEPPE M PERETTI, Principal investigator, IRCCS Istituto Ortopedico Galeazzi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221425
- Sponsor's protocol ID
- TELERIABILITAZIONE
- Status last verified
- Nov 2021
- First submitted
- 7 Jan 2020
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eichler S, Rabe S, Salzwedel A, Muller S, Stoll J, Tilgner N, John M, Wegscheider K, Mayer F, Voller H; ReMove-It study group. Effectiveness of an interactive telerehabilitation system with home-based exercise training in patients after total hip or knee replacement: study protocol for a multicenter, superiority, no-blinded randomized controlled trial. Trials. 2017 Sep 21;18(1):438. doi: 10.1186/s13063-017-2173-3.
PubMed 28934966
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Recovery Evaluation Following Total Hip Arthroplasty And Early Home Rehabilitation Program With A Virtual Reality Based Rehabilitation System
- ClinicalTrials.gov ID
- NCT04221425
- Acronym / sponsor ID
- TELERIABILITAZIONE
- Conditions
- Osteoarthritis, Hip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 16 Feb 2021 (actual)
- Study completion
- 16 Feb 2021 (actual)
- First posted
- 9 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.
Total hip replacement (THR) is one of the most common interventions in orthopedic surgery.
Rehabilitation is essential for maximizing the effectiveness of the surgery. Tele-rehabilitation programs after orthopedic surgery have proven their effectiveness, validity and cost-efficacy.
It seems of interest to test the potential advantages of early virtual reality based rehabilitation programs after total hip arthroplasty compared to standard care. The aim of the study is to evaluate the functional recovery following total hip arthroplasty and home telerehabilitation programs with a virtual reality based system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VRRS GROUP | Experimental | Procedure: virtual reality rehabilitation system (VRRS)Home rehabilitation program is provided through a virtual reality based telerehabilitation system |
| CONTROL GROUP | Active comparator | Procedure: standard careHome rehabilitation program is provided through illustrative booklet containing characteristics of exercises and indications for recovery |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- males and females from 50 to 70 years old
- patients undergoing total hip arthroplasty with Anterior Minimally Invasive Surgery (AMIS)
- Body Mass Index ≤ 31
- Schooling: Lower secondary certificate
- Home internet connection
Key exclusion criteria (7 listed)
- congenital or post traumatic morphological abnormalities
- presence of neurological conditions or cancer
- presence of implanted devices subjected to electromagnetic interference
- epilepsy
- informed refusal
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 |
|---|---|---|
| virtual reality rehabilitation system (VRRS)experimental group is equipped with a telerehabilitation system which comprises a tablet (VRRS tablet) and a set of inertial magnetic sensors. participants are invited to follow a daily rehabilitation exercise program provided via VRRS tablet | Procedure or surgery | VRRS GROUP |
| standard careparticipants in the control group are invited to follow a daily rehabilitation exercise program and indications for the recovery as illustrated in the dimission booklets drawn up by the rehabilitation unit | Procedure or surgery | CONTROL GROUP |
Primary outcome
Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
Time frame: 15 ± 1 days after the surgery (T3)
the HOOS JR scale scores ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health
4 secondary outcomes
Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
Time frame: baseline (before surgery (T0)), 4 ± 1 days after the surgery (T1), 7 ± 2 days after the surgery (T2)
BARTHEL INDEX (BI)
Time frame: baseline (before surgery (T0)), 4 ± 1 days after the surgery (T1), 15 ± 1 days after the surgery (T3)
Functional Independence Measure (FIM)
Time frame: baseline (before surgery (T0)), 4 ± 1 days after the surgery (T1), 15 ± 1 days after the surgery (T3)
Global Perceived Effect (GPE)
Time frame: 15 ± 1 days after the surgery (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Background: PubMed 28934966Eichler S, Rabe S, Salzwedel A, Muller S, Stoll J, Tilgner N, John M, Wegscheider K, Mayer F, Voller H; ReMove-It study group. Effectiveness of an interactive telerehabilitation system with home-based exercise training in patients after total hip or knee replacement: study protocol for a multicenter, superiority, no-blinded randomized controlled trial. Trials. 2017 Sep 21;18(1):438. doi: 10.1186/s13063-017-2173-3.
- Individual participant dataSharing planned: No
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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.
GIUSEPPE M PERETTI principal investigator
IRCCS Istituto Ortopedico Galeazzi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality rehabilitation system (VRRS) in people with Osteoarthritis, Hip, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio 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?
The sponsor lists 8 inclusion and 7 exclusion criteria. 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: finished, as of the sponsor's last update on 8 Nov 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) (time frame: 15 ± 1 days after the surgery (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04221425, which also lists 1 linked publication.
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 8 Nov 2021; AzTrials last refreshed its copy on 31 Oct 2026.