Total Hip ArthroplastyNCT05173480
Does Virtual Reality Rehabilitation Improve Mobility, Balance, and Walking in Patients With Total Hip Arthroplasty?
A study testing Conventional rehabilitation and Virtual Reality Rehabilitation System (VRRS) in people with Total Hip Arthroplasty, run by Mauro Crestani at 1 site in Italy.
Trial summary
This study aims to assess the efficacy of virtual reality through the Virtual Reality Rehabilitation System (VRRS) added to conventional rehabilitation versus conventional rehabilitation alone, for improving mobility, balance, and walking assessed by Timed Up and Go after primary Total Hip Arthroplasty. Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Conventional rehabilitation and Virtual Reality Rehabilitation System (VRRS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2022to 1 Jun 2024
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age: 45-85 years
- primary unilateral THA for hip osteoarthritis
- signed informed consent
Who cannot join
- people with clinically unstable serious diseases (e.g., heart or lung disease)
- secondary THA replacement on the same side
- hip replacement for neoplasm, proximal femoral fracture, or other causes out of osteoarthritis
- contemporary bilateral replacement
- cancer
- presence of neurological diseases previous or following surgery
Show all 10Show fewer
- congenital abnormalities
- patients with THA infection
- diabetes
- psychotropic drugs assumption for pain management
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AULSS 9 - Marzana Hospital
Verona, 37142
MAURO CRESTANI, 3381479872, mauro.crestani.93@gmail.com
About this study
Official title: Does Virtual Reality Rehabilitation Added to Conventional Physiotherapy Improve Mobility, Balance, and Walking Assessed by Timed Up and Go in Patients With Total Hip Arthroplasty? A Randomized Controlled Trial
This study aims to assess the efficacy of virtual reality through the Virtual Reality Rehabilitation System (VRRS) added to conventional rehabilitation versus conventional rehabilitation alone, for improving mobility, balance, and walking assessed by Timed Up and Go after primary Total Hip Arthroplasty.
Read the detailed description
Following ethics approval by the ULSS 9, adults with THA (at 7 days after surgery), aged between 45 and 85 years old will be recruited for the study by the office worker of the rehabilitation hospital. Patients will be informed about the aim of the study and will sign the informed consent. Patients that decided to participate in the study will be randomized into two rehabilitation groups: experimental group and control group. Patients will be evaluated for reaching the baseline data from a physiotherapist blind to the aim of the study. Both groups (experimental and control) will receive the same clinical indications during hospitalization. Both groups will perform the same daily warm-up exercises supervised by physiotherapists external to the study investigation and will receive the same conventional-exercises program. In addition to this, each group will perform a second rehabilitation session with the virtual reality, using the Virtual Reality Rehabilitation System (VRRS), but in the control group, the sensors of VRRS will be not connected. The primary outcome will be the Timed Up and Go (TUG), the test used to assess mobility, balance, and walking.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Conventional rehabilitation, Virtual Reality Rehabilitation System (VRRS)
- Keywords
- Virtual reality rehabilitation, Physiotherapy, Physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional rehabilitationOther
Exercise therapy through conventional rehabilitation training made by physiotherapists.
Virtual Reality Rehabilitation System (VRRS)Device
Exercise therapy through a virtual reality rehabilitation system (VRRS).
Virtual Reality Rehabilitation System (VRRS)Device
Exercise therapy through a virtual reality rehabilitation system (VRRS) with sensors not connected.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | VRRS rehabilitation exercise therapy through a virtual reality rehabilitation system in addition to conventional rehabilitation. Receives: Other: Conventional rehabilitation; Device: Virtual Reality Rehabilitation System (VRRS) |
| Control group | Active comparator | VRRS rehabilitation exercise therapy through a virtual reality rehabilitation system, with sensors not connected, in addition to conventional rehabilitation. Receives: Other: Conventional rehabilitation; Device: Virtual Reality Rehabilitation System (VRRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Timed Up and Go (TUG) score
The TUG is a timed test used to assess mobility, balance, and walking. The subject must stand up from a chair, walk a distance of 3 meters, turn around, walk back to the chair and sit down - all performed as quickly and as safely as possible.
Measured: baseline (7 days after surgery) and at discharge (28 days after surgery)
Secondary outcomes (8)
Change in the Hip dysfunction and Osteoarthritis Outcome Score (HOOS)
The HOOS scale scores range from 0 to 100 (0: total hip disability, 100: perfect hip health)
Measured: baseline (7 days after the surgery), at discharge (28 days after surgery) and at 6 months after surgery (by telephone interview)
Change in the Numeric Rating Scale for pain (NPRS)
A 10-cm Numerical Pain Rating Scale (0: no pain, 10: maximum pain) will be used to assess the current level of hip pain before rehabilitation treatment.
Measured: baseline (7 days after surgery), at discharge (28 days after surgery) and at 6 months
Change in the Hip Active Range of Motion
Assessed by goniometer (degree of movement)
Measured: baseline (7 days after surgery) and at discharge (28 days after surgery)
Change in the Strength of main muscles of the pelvis and thigh of the affected limb
Assessed by dynamometer
Measured: baseline (7 days after surgery) and at discharge (28 days after surgery)
Change in the 6 Minutes Walking Test (6MWT)
Walking ability and cardio-respiratory function
Measured: baseline (7 days after surgery) and at discharge (28 days after surgery)
Change in the Short Form Health Survey 36 (SF-36)
Short Form Health Survey scores range from 0 to 100 (0: maximum disability; 100: no disability)
Measured: baseline (7 days after surgery) and at discharge (28 days after surgery) and at 6 months (telephone interview)
Change in the Numeric Rating of Patient Satisfaction with functional outcome
A 10-cm Numeric Rating of Patient Satisfaction with the functional outcome (0: no satisfaction; 10: maximum satisfaction) is used to assess the general satisfaction of the patients
Measured: assessed and reported at discharge (28 days after surgery) at 6 months (telephone interview)
The drugs assumption for pain management
Type of drugs intake for each group during rehabilitation recovery
Measured: assessed and reported at discharge (28 days after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start15 Mar 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mauro Crestani
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Mauro Crestani, Azienda Ulss 9 Scaligera
- Investigators
- Mauro Crestani, Principal investigator, Azienda Ulss 9 Scaligera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173480
- Sponsor's protocol ID
- AziendaU9S
- Status last verified
- Jan 2023
- First submitted
- 8 Dec 2021
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Virtual Reality Rehabilitation Added to Conventional Physiotherapy Improve Mobility, Balance, and Walking Assessed by Timed Up and Go in Patients With Total Hip Arthroplasty? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05173480
- Acronym / sponsor ID
- AziendaU9S
- Conditions
- Total Hip Arthroplasty
- Keywords
- Virtual reality rehabilitation, Physiotherapy, Physical therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Mauro CrestaniOther government
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 30 Dec 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.
This study aims to assess the efficacy of virtual reality through the Virtual Reality Rehabilitation System (VRRS) added to conventional rehabilitation versus conventional rehabilitation alone, for improving mobility, balance, and walking assessed by Timed Up and Go after primary Total Hip Arthroplasty.
Detailed description
Following ethics approval by the ULSS 9, adults with THA (at 7 days after surgery), aged between 45 and 85 years old will be recruited for the study by the office worker of the rehabilitation hospital. Patients will be informed about the aim of the study and will sign the informed consent. Patients that decided to participate in the study will be randomized into two rehabilitation groups: experimental group and control group. Patients will be evaluated for reaching the baseline data from a physiotherapist blind to the aim of the study. Both groups (experimental and control) will receive the same clinical indications during hospitalization. Both groups will perform the same daily warm-up exercises supervised by physiotherapists external to the study investigation and will receive the same conventional-exercises program. In addition to this, each group will perform a second rehabilitation session with the virtual reality, using the Virtual Reality Rehabilitation System (VRRS), but in the control group, the sensors of VRRS will be not connected. The primary outcome will be the Timed Up and Go (TUG), the test used to assess mobility, balance, and walking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Conventional rehabilitation, Device: Virtual Reality Rehabilitation System (VRRS)VRRS rehabilitation exercise therapy through a virtual reality rehabilitation system in addition to conventional rehabilitation. |
| Control group | Active comparator | Other: Conventional rehabilitation, Device: Virtual Reality Rehabilitation System (VRRS)VRRS rehabilitation exercise therapy through a virtual reality rehabilitation system, with sensors not connected, in addition to conventional rehabilitation. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age: 45-85 years
- primary unilateral THA for hip osteoarthritis
- signed informed consent
Key exclusion criteria (10 listed)
- people with clinically unstable serious diseases (e.g., heart or lung disease)
- secondary THA replacement on the same side
- hip replacement for neoplasm, proximal femoral fracture, or other causes out of osteoarthritis
- contemporary bilateral replacement
- cancer
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 |
|---|---|---|
| Conventional rehabilitationExercise therapy through conventional rehabilitation training made by physiotherapists. | Other | Control group, Experimental group |
| Virtual Reality Rehabilitation System (VRRS)Exercise therapy through a virtual reality rehabilitation system (VRRS). | Device | Experimental group |
| Virtual Reality Rehabilitation System (VRRS)Exercise therapy through a virtual reality rehabilitation system (VRRS) with sensors not connected. | Device | Control group |
Primary outcome
Change in the Timed Up and Go (TUG) score
Time frame: baseline (7 days after surgery) and at discharge (28 days after surgery)
The TUG is a timed test used to assess mobility, balance, and walking. The subject must stand up from a chair, walk a distance of 3 meters, turn around, walk back to the chair and sit down - all performed as quickly and as safely as possible.
8 secondary outcomes
Change in the Hip dysfunction and Osteoarthritis Outcome Score (HOOS)
Time frame: baseline (7 days after the surgery), at discharge (28 days after surgery) and at 6 months after surgery (by telephone interview)
Change in the Numeric Rating Scale for pain (NPRS)
Time frame: baseline (7 days after surgery), at discharge (28 days after surgery) and at 6 months
Change in the Hip Active Range of Motion
Time frame: baseline (7 days after surgery) and at discharge (28 days after surgery)
Change in the Strength of main muscles of the pelvis and thigh of the affected limb
Time frame: baseline (7 days after surgery) and at discharge (28 days after surgery)
Change in the 6 Minutes Walking Test (6MWT)
Time frame: baseline (7 days after surgery) and at discharge (28 days after surgery)
Change in the Short Form Health Survey 36 (SF-36)
Time frame: baseline (7 days after surgery) and at discharge (28 days after surgery) and at 6 months (telephone interview)
Change in the Numeric Rating of Patient Satisfaction with functional outcome
Time frame: assessed and reported at discharge (28 days after surgery) at 6 months (telephone interview)
The drugs assumption for pain management
Time frame: assessed and reported at discharge (28 days after surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
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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.
Mauro Crestani principal investigator
Azienda Ulss 9 Scaligera
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional rehabilitation and Virtual Reality Rehabilitation System (VRRS) in people with Total Hip Arthroplasty, run by Mauro Crestani 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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 31 Jan 2023. 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?
Contact Mauro Crestani (3381479872, mauro.crestani.93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Timed Up and Go (TUG) score (time frame: baseline (7 days after surgery) and at discharge (28 days after surgery)). 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 31 Jan 2023.