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Early Virtual Reality Based Home Rehabilitation Program After Total Hip Arthroplasty

Sponsor
Istituto Ortopedico Galeazzi (Other)
Overall Status
Completed
CT.gov ID
NCT04221425
Collaborator
(none)
44
Enrollment
1
Location
2
Arms
23.6
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: virtual reality rehabilitation system (VRRS)
  • Procedure: standard care
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Functional Recovery Evaluation Following Total Hip Arthroplasty And Early Home Rehabilitation Program With A Virtual Reality Based Rehabilitation System
Actual Study Start Date :
Mar 1, 2019
Actual Primary Completion Date :
Feb 16, 2021
Actual Study Completion Date :
Feb 16, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: VRRS GROUP

Home rehabilitation program is provided through a virtual reality based telerehabilitation system

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
Active Comparator: CONTROL GROUP

Home rehabilitation program is provided through illustrative booklet containing characteristics of exercises and indications for recovery

Procedure: 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. 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)

  4. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS Istituto Ortopedico Galeazzi Milan Italy 20161

Sponsors and Collaborators

  • Istituto Ortopedico Galeazzi

Investigators

  • Principal Investigator: GIUSEPPE M PERETTI, IRCCS Istituto Ortopedico Galeazzi

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Istituto Ortopedico Galeazzi
ClinicalTrials.gov Identifier:
NCT04221425
Other Study ID Numbers:
  • TELERIABILITAZIONE
First Posted:
Jan 9, 2020
Last Update Posted:
Nov 8, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Osteoarthritis, Hip

Study Results

No Results Posted as of Nov 8, 2021