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Early Virtual Reality Based Home Rehabilitation Program After Total Hip Arthroplasty

Primary Purpose

Osteoarthritis, Hip

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
virtual reality rehabilitation system (VRRS)
standard care
Sponsored by
Istituto Ortopedico Galeazzi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IRCCS Istituto Ortopedico Galeazzi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VRRS GROUP

CONTROL GROUP

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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)
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

Full Information

First Posted
January 7, 2020
Last Updated
November 5, 2021
Sponsor
Istituto Ortopedico Galeazzi
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1. Study Identification

Unique Protocol Identification Number
NCT04221425
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
February 16, 2021 (Actual)
Study Completion Date
February 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Galeazzi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VRRS GROUP
Arm Type
Experimental
Arm Description
Home rehabilitation program is provided through a virtual reality based telerehabilitation system
Arm Title
CONTROL GROUP
Arm Type
Active Comparator
Arm Description
Home rehabilitation program is provided through illustrative booklet containing characteristics of exercises and indications for recovery
Intervention Type
Procedure
Intervention Name(s)
virtual reality rehabilitation system (VRRS)
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
standard care
Intervention Description
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 Outcome Measure Information:
Title
Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
Description
the HOOS JR scale scores ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health
Time Frame
15 ± 1 days after the surgery (T3)
Secondary Outcome Measure Information:
Title
Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
Description
the HOOS JR scale scores ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health
Time Frame
baseline (before surgery (T0)), 4 ± 1 days after the surgery (T1), 7 ± 2 days after the surgery (T2)
Title
BARTHEL INDEX (BI)
Description
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
Time Frame
baseline (before surgery (T0)), 4 ± 1 days after the surgery (T1), 15 ± 1 days after the surgery (T3)
Title
Functional Independence Measure (FIM)
Description
The Functional Independence Measure (FIM) explores an individual's physical, psychological and social function. Its scores ranges from 18 (lowest) to 126 (highest)
Time Frame
baseline (before surgery (T0)), 4 ± 1 days after the surgery (T1), 15 ± 1 days after the surgery (T3)
Title
Global Perceived Effect (GPE)
Description
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
Time Frame
15 ± 1 days after the surgery (T3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GIUSEPPE M PERETTI
Organizational Affiliation
IRCCS Istituto Ortopedico Galeazzi
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Istituto Ortopedico Galeazzi
City
Milan
ZIP/Postal Code
20161
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28934966
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.
Results Reference
background

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Early Virtual Reality Based Home Rehabilitation Program After Total Hip Arthroplasty

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