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Completed

NCT Number: NCT04221425

Early Virtual Reality Based Home Rehabilitation Program After Total Hip Arthroplasty

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.

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Key information

Conditions

Osteoarthritis, Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto Ortopedico Galeazzi

Milan, 20161, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

virtual reality rehabilitation system (VRRS)

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

Standard care

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

Primary outcomes

  1. Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)

    Time frame: 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 outcomes

  1. Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)

    Time frame: 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

  2. BARTHEL INDEX (BI)

    Time frame: 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

  3. Functional Independence Measure (FIM)

    Time frame: 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)

  4. Global Perceived Effect (GPE)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 9, 2020
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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