Hip DiseaseVRRS2018NCT05001100
A Rehabilitation With Virtual Reality in Patients After Hip Arthroplasty Surgery (VRRS2018)
A study testing rehabilitation in people with Hip Disease, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
.Assessing efficacy of rehabilitation with virtual reality exercises compared to traditional rehabilitation in the patient's operated hip arthroplasty Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Hip Disease
- What is being tested?
- rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jan 2019to 7 Nov 2020
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hip arthroplasty
Who cannot join
- patient with resence of neurological and psychiatric disorders
- minor patient
Trial locations and contacts
1 site in 1 country.
About this study
.Assessing efficacy of rehabilitation with virtual reality exercises compared to traditional rehabilitation in the patient's operated hip arthroplasty
Read the detailed description
Randomized controlled clinical study: Comparison of clinical efficacy between rehabilitation with virtual reality (VRRS) and traditional physiotherapy in post-surgical rehabilitation treatment in hospital. Motor clinical evaluations will be carried out in both groups.
Vrrs Arm: 32 subjects will undergo a virtual motor-reality training during the post-surgical rehabilitation period.
Physiotherapist's arm: 32 subjects with demographic characteristics similar to the subjects of the Vrrs arm will undergo the habitual rehabilitative physiotherapy.
According to normal clinical practice, both groups perform a co-intervention in addition to the assigned group; Manual therapy with exercises and functional activity (walk and stairs).
- Conditions
- Hip Disease
- Being tested
- rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitationOther
rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Traditional rehabilitation | Active comparator | 32 subjects will undergo a virtual motor-reality training during the post-surgical rehabilitation period with VRSS Receives: Other: rehabilitation |
| Rehabilitation with virtual reality | Experimental | 32 subjects with demographic characteristics similar to the subjects of the Vrrs arm will undergo the habitual rehabilitative physiotherapy. Receives: Other: rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
disability measurement
WOMAC (Western Ontario and McMaster University) Osteoarthritis index
Measured: on the 21st day
Secondary outcomes (1)
pain measurement
visual analoge scale VAS
Measured: on the 10st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start20 Jan 2019
- Primary completion10 Oct 2020
- Study completion7 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip DiseaseStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- 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
- Model description
- randomized
- Masking
- None (open label)
- Enrolment
- 64 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
- cristina beretta, MD, Principal investigator, istituto galeazzi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001100
- Sponsor's protocol ID
- VRRS2018
- Acronym
- VRRS2018
- Status last verified
- Jul 2021
- First submitted
- 29 Jul 2021
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Rehabilitation With Virtual Reality in Patients After Hip Arthroplasty Surgery (VRRS2018)
- ClinicalTrials.gov ID
- NCT05001100
- Acronym / sponsor ID
- VRRS2018 / VRRS2018
- Conditions
- Hip Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 10 Oct 2020 (actual)
- Study completion
- 7 Nov 2020 (actual)
- First posted
- 11 Aug 2021 (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.
.Assessing efficacy of rehabilitation with virtual reality exercises compared to traditional rehabilitation in the patient's operated hip arthroplasty
Detailed description
Randomized controlled clinical study: Comparison of clinical efficacy between rehabilitation with virtual reality (VRRS) and traditional physiotherapy in post-surgical rehabilitation treatment in hospital. Motor clinical evaluations will be carried out in both groups.
Vrrs Arm: 32 subjects will undergo a virtual motor-reality training during the post-surgical rehabilitation period.
Physiotherapist's arm: 32 subjects with demographic characteristics similar to the subjects of the Vrrs arm will undergo the habitual rehabilitative physiotherapy.
According to normal clinical practice, both groups perform a co-intervention in addition to the assigned group; Manual therapy with exercises and functional activity (walk and stairs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized
| Arm | Type | Receives |
|---|---|---|
| Traditional rehabilitation | Active comparator | Other: rehabilitation32 subjects will undergo a virtual motor-reality training during the post-surgical rehabilitation period with VRSS |
| Rehabilitation with virtual reality | Experimental | Other: rehabilitation32 subjects with demographic characteristics similar to the subjects of the Vrrs arm will undergo the habitual rehabilitative physiotherapy. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hip arthroplasty
Key exclusion criteria (2 listed)
- patient with resence of neurological and psychiatric disorders
- minor patient
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 |
|---|---|---|
| rehabilitationrehabilitation | Other | Rehabilitation with virtual reality, Traditional rehabilitation |
Primary outcome
disability measurement
Time frame: on the 21st day
WOMAC (Western Ontario and McMaster University) Osteoarthritis index
1 secondary outcome
pain measurement
Time frame: on the 10st day
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 11 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Hip Disease
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
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Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
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PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
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Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
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.
cristina beretta, MD principal investigator
istituto 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 rehabilitation in people with Hip Disease, 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 1 inclusion and 2 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 11 Aug 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?
disability measurement (time frame: on the 21st day). 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 11 Aug 2021.