Early Virtual Reality Based Home Rehabilitation Program After Total Hip Arthroplasty
Functional Recovery Evaluation Following Total Hip Arthroplasty And Early Home Rehabilitation Program With A Virtual Reality Based Rehabilitation System
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2019
CompletedFirst Submitted
Initial submission to the registry
January 7, 2020
CompletedFirst Posted
Study publicly available on registry
January 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 16, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 16, 2021
CompletedNovember 8, 2021
November 1, 2021
2 years
January 7, 2020
November 5, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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)
Functional Independence Measure (FIM)
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)
Study Arms (2)
VRRS GROUP
EXPERIMENTALHome rehabilitation program is provided through a virtual reality based telerehabilitation system
CONTROL GROUP
ACTIVE COMPARATORHome rehabilitation program is provided through illustrative booklet containing characteristics of exercises and indications for recovery
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Istituto Ortopedico Galeazzi
Milan, 20161, Italy
Related Publications (1)
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.
PMID: 28934966BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
GIUSEPPE M PERETTI
IRCCS Istituto Ortopedico Galeazzi
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2020
First Posted
January 9, 2020
Study Start
March 1, 2019
Primary Completion
February 16, 2021
Study Completion
February 16, 2021
Last Updated
November 8, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share