Early Virtual Reality Based Home Rehabilitation Program After Total Hip Arthroplasty

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04221425
• Other study ID #: TELERIABILITAZIONE
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: February 16, 2021

Study information

• Verified date: November 2021
• Source: Istituto Ortopedico Galeazzi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: February 16, 2021
• Est. primary completion date: February 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Hip

Intervention

Procedure:
• 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
• 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

Locations

Country	Name	City	State
Italy	IRCCS Istituto Ortopedico Galeazzi	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Eichler S, Rabe S, Salzwedel A, Müller S, Stoll J, Tilgner N, John M, Wegscheider K, Mayer F, Völler 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)