Early Virtual Reality Based Home Rehabilitation Program After Total Hip Arthroplasty

Not Applicable

Completed

• Conditions: Osteoarthritis, Hip
• Interventions: Procedure: virtual reality rehabilitation system (VRRS); Procedure: standard care

• Registration Number: NCT04221425
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Brief Summary

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

Not available

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-07
• Study First Posted: 2020-01-09
• Primary Completion: 2021-02-16
• Study Completion: 2021-02-16
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VRRS GROUP	virtual reality rehabilitation system (VRRS)	Home rehabilitation program is provided through a virtual reality based telerehabilitation system
CONTROL GROUP	standard care	Home rehabilitation program is provided through illustrative booklet containing characteristics of exercises and indications for recovery

Primary Outcome Measures

Name	Time	Method
Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)	15 ± 1 days after the surgery (T3)	the HOOS JR scale scores ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health

Secondary Outcome Measures

Name	Time	Method
Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)	baseline (before surgery (T0)), 4 ± 1 days after the surgery (T1), 7 ± 2 days after the surgery (T2)	the HOOS JR scale scores ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health
BARTHEL INDEX (BI)	baseline (before surgery (T0)), 4 ± 1 days after the surgery (T1), 15 ± 1 days after the surgery (T3)	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
Global Perceived Effect (GPE)	15 ± 1 days after the surgery (T3)	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
Functional Independence Measure (FIM)	baseline (before surgery (T0)), 4 ± 1 days after the surgery (T1), 15 ± 1 days after the surgery (T3)	The Functional Independence Measure (FIM) explores an individual's physical, psychological and social function. Its scores ranges from 18 (lowest) to 126 (highest)

Trial Locations

Locations (1)

IRCCS Istituto Ortopedico Galeazzi; 🇮🇹 Milan, Italy