Clinical trial NCT04221425: Early Virtual Reality Based Home Rehabilitation Program After Total Hip Arthroplasty
Official title: Functional Recovery Evaluation Following Total Hip Arthroplasty And Early Home Rehabilitation Program With A Virtual Reality Based Rehabilitation System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Hip
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2020-01-09
Enrollment: 44
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
timeFrame: 15 ± 1 days after the surgery (T3)
Secondary outcomes:
measure: Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
timeFrame: baseline (before surgery (T0)), 4 ± 1 days after the surgery (T1), 7 ± 2 days after the surgery (T2)
measure: BARTHEL INDEX (BI)
timeFrame: baseline (before surgery (T0)), 4 ± 1 days after the surgery (T1), 15 ± 1 days after the surgery (T3)
measure: Functional Independence Measure (FIM)
timeFrame: baseline (before surgery (T0)), 4 ± 1 days after the surgery (T1), 15 ± 1 days after the surgery (T3)
measure: Global Perceived Effect (GPE)
timeFrame: 15 ± 1 days after the surgery (T3)
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
Study officials:
affiliation: IRCCS Istituto Ortopedico Galeazzi
name: GIUSEPPE M PERETTI
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.