A Rehabilitation With Virtual Reality in Patients After Hip Arthroplasty Surgery (VRRS2018) (VRRS2018)

August 6, 2021 updated by: Istituto Ortopedico Galeazzi
.Assessing efficacy of rehabilitation with virtual reality exercises compared to traditional rehabilitation in the patient's operated hip arthroplasty

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized controlled clinical study: Comparison of clinical efficacy between rehabilitation with virtual reality (VRRS) and traditional physiotherapy in post-surgical rehabilitation treatment in hospital. Motor clinical evaluations will be carried out in both groups.

Vrrs Arm: 32 subjects will undergo a virtual motor-reality training during the post-surgical rehabilitation period.

Physiotherapist's arm: 32 subjects with demographic characteristics similar to the subjects of the Vrrs arm will undergo the habitual rehabilitative physiotherapy.

According to normal clinical practice, both groups perform a co-intervention in addition to the assigned group; Manual therapy with exercises and functional activity (walk and stairs).

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20133
        • IRCCS Istituto Ortopedico Galeazzi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- hip arthroplasty

Exclusion Criteria:

  • patient with resence of neurological and psychiatric disorders
  • minor patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Traditional rehabilitation
32 subjects will undergo a virtual motor-reality training during the post-surgical rehabilitation period with VRSS
Other: rehabilitation
rehabilitation
EXPERIMENTAL: Rehabilitation with virtual reality
32 subjects with demographic characteristics similar to the subjects of the Vrrs arm will undergo the habitual rehabilitative physiotherapy.
Other: rehabilitation
rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disability measurement
Time Frame: on the 21st day
WOMAC (Western Ontario and McMaster University) Osteoarthritis index
on the 21st day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain measurement
Time Frame: on the 10st day
visual analoge scale VAS
on the 10st day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Galeazzi

Investigators

  • Principal Investigator: cristina beretta, MD, istituto galeazzi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 20, 2019

Primary Completion (ACTUAL)

October 10, 2020

Study Completion (ACTUAL)

November 7, 2020

Study Registration Dates

First Submitted

July 29, 2021

First Submitted That Met QC Criteria

August 6, 2021

First Posted (ACTUAL)

August 11, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 11, 2021

Last Update Submitted That Met QC Criteria

August 6, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • VRRS2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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