Early Virtual Reality Based Home Rehabilitation Program After Total Hip Arthroplasty

NCT ID: NCT04221425

Last Updated: 2021-11-08

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

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2021-02-16

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis, Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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VRRS GROUP

Home rehabilitation program is provided through a virtual reality based telerehabilitation system

Group Type EXPERIMENTAL

virtual reality rehabilitation system (VRRS)

Intervention Type PROCEDURE

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

CONTROL GROUP

Home rehabilitation program is provided through illustrative booklet containing characteristics of exercises and indications for recovery

Group Type ACTIVE_COMPARATOR

standard care

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

standard care

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GIUSEPPE M PERETTI

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituto Ortopedico Galeazzi

Locations

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IRCCS Istituto Ortopedico Galeazzi

Milan, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 28934966 (View on PubMed)

Other Identifiers

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TELERIABILITAZIONE

Identifier Type: -

Identifier Source: org_study_id