Does Virtual Reality Rehabilitation Improve Mobility, Balance, and Walking in Patients With Total Hip Arthroplasty?

NCT ID: NCT05173480

Last Updated: 2023-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-15

Study Completion Date

2024-06-01

Brief Summary

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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

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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

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Total Hip Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental group

VRRS rehabilitation exercise therapy through a virtual reality rehabilitation system in addition to conventional rehabilitation.

Group Type EXPERIMENTAL

Conventional rehabilitation

Intervention Type OTHER

Exercise therapy through conventional rehabilitation training made by physiotherapists.

Virtual Reality Rehabilitation System (VRRS)

Intervention Type DEVICE

Exercise therapy through a virtual reality rehabilitation system (VRRS).

Control group

VRRS rehabilitation exercise therapy through a virtual reality rehabilitation system, with sensors not connected, in addition to conventional rehabilitation.

Group Type ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type OTHER

Exercise therapy through conventional rehabilitation training made by physiotherapists.

Virtual Reality Rehabilitation System (VRRS)

Intervention Type DEVICE

Exercise therapy through a virtual reality rehabilitation system (VRRS) with sensors not connected.

Interventions

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Conventional rehabilitation

Exercise therapy through conventional rehabilitation training made by physiotherapists.

Intervention Type OTHER

Virtual Reality Rehabilitation System (VRRS)

Exercise therapy through a virtual reality rehabilitation system (VRRS).

Intervention Type DEVICE

Virtual Reality Rehabilitation System (VRRS)

Exercise therapy through a virtual reality rehabilitation system (VRRS) with sensors not connected.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* age: 45-85 years
* primary unilateral THA for hip osteoarthritis
* signed informed consent

Exclusion Criteria

* 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
* congenital abnormalities
* patients with THA infection
* diabetes
* psychotropic drugs assumption for pain management
Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mauro Crestani

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mauro Crestani

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mauro Crestani

Role: PRINCIPAL_INVESTIGATOR

Azienda Ulss 9 Scaligera

Locations

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AULSS 9 - Marzana Hospital

Verona, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Mauro Crestani

Role: CONTACT

3381479872

Facility Contacts

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MAURO CRESTANI

Role: primary

3381479872

Other Identifiers

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AziendaU9S

Identifier Type: -

Identifier Source: org_study_id

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