Early Virtual Reality Based Home Rehabilitation Program After Total Hip Arthroplasty

Study Overview
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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.

Official Title
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Functional Recovery Evaluation Following Total Hip Arthroplasty And Early Home Rehabilitation Program With A Virtual Reality Based Rehabilitation System

Conditions
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Osteoarthritis, Hip

Intervention / Treatment
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* Procedure: virtual reality rehabilitation system (VRRS)
* Procedure: standard care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VRRS GROUP<br>Home rehabilitation program is provided through a virtual reality based telerehabilitation system | Procedure: virtual reality rehabilitation system (VRRS)<br>* 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<br>|
| Active Comparator: CONTROL GROUP<br>Home rehabilitation program is provided through illustrative booklet containing characteristics of exercises and indications for recovery | Procedure: standard care<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 15 ± 1 days after the surgery (T3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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) | 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 | 15 ± 1 days after the surgery (T3) |