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Clinical Trials/NCT04221425
NCT04221425
Completed
N/A

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

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio1 site in 1 country44 target enrollmentMarch 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Osteoarthritis, Hip
Sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Enrollment
44
Locations
1
Primary Endpoint
Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
February 16, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Responsible Party
Sponsor

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
  • informed refusal
  • Ongoing anticoagulant or immunosuppressive therapies before surgery
  • Self reported pregnancy

Outcomes

Primary Outcomes

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

  • 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))
  • BARTHEL INDEX (BI)(baseline (before surgery (T0)), 4 ± 1 days after the surgery (T1), 15 ± 1 days after the surgery (T3))
  • Global Perceived Effect (GPE)(15 ± 1 days after the surgery (T3))
  • Functional Independence Measure (FIM)(baseline (before surgery (T0)), 4 ± 1 days after the surgery (T1), 15 ± 1 days after the surgery (T3))

Study Sites (1)

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