Does Virtual Reality Rehabilitation Improve Mobility, Balance, and Walking in Patients With Total Hip Arthroplasty?

January 30, 2023 updated by: Mauro Crestani

Does Virtual Reality Rehabilitation Added to Conventional Physiotherapy Improve Mobility, Balance, and Walking Assessed by Timed Up and Go in Patients With Total Hip Arthroplasty? A Randomized Controlled Trial

This study aims to assess the efficacy of virtual reality through the Virtual Reality Rehabilitation System (VRRS) added to conventional rehabilitation versus conventional rehabilitation alone, for improving mobility, balance, and walking assessed by Timed Up and Go after primary Total Hip Arthroplasty.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Following ethics approval by the ULSS 9, adults with THA (at 7 days after surgery), aged between 45 and 85 years old will be recruited for the study by the office worker of the rehabilitation hospital. Patients will be informed about the aim of the study and will sign the informed consent. Patients that decided to participate in the study will be randomized into two rehabilitation groups: experimental group and control group. Patients will be evaluated for reaching the baseline data from a physiotherapist blind to the aim of the study. Both groups (experimental and control) will receive the same clinical indications during hospitalization. Both groups will perform the same daily warm-up exercises supervised by physiotherapists external to the study investigation and will receive the same conventional-exercises program. In addition to this, each group will perform a second rehabilitation session with the virtual reality, using the Virtual Reality Rehabilitation System (VRRS), but in the control group, the sensors of VRRS will be not connected. The primary outcome will be the Timed Up and Go (TUG), the test used to assess mobility, balance, and walking.

Study Type

Interventional

Enrollment (Anticipated)

75

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 Contact

Study Locations

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 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age: 45-85 years
  • primary unilateral THA for hip osteoarthritis
  • signed informed consent

Exclusion Criteria:

  • people with clinically unstable serious diseases (e.g., heart or lung disease)
  • secondary THA replacement on the same side
  • hip replacement for neoplasm, proximal femoral fracture, or other causes out of osteoarthritis
  • contemporary bilateral replacement
  • cancer
  • presence of neurological diseases previous or following surgery
  • congenital abnormalities
  • patients with THA infection
  • diabetes
  • psychotropic drugs assumption for pain management

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: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental group
VRRS rehabilitation exercise therapy through a virtual reality rehabilitation system in addition to conventional rehabilitation.
Other: Conventional rehabilitation
Exercise therapy through conventional rehabilitation training made by physiotherapists.
Device: Virtual Reality Rehabilitation System (VRRS)
Exercise therapy through a virtual reality rehabilitation system (VRRS).
Device: Virtual Reality Rehabilitation System (VRRS)
Exercise therapy through a virtual reality rehabilitation system (VRRS) with sensors not connected.
ACTIVE_COMPARATOR: Control group
VRRS rehabilitation exercise therapy through a virtual reality rehabilitation system, with sensors not connected, in addition to conventional rehabilitation.
Other: Conventional rehabilitation
Exercise therapy through conventional rehabilitation training made by physiotherapists.
Device: Virtual Reality Rehabilitation System (VRRS)
Exercise therapy through a virtual reality rehabilitation system (VRRS).
Device: Virtual Reality Rehabilitation System (VRRS)
Exercise therapy through a virtual reality rehabilitation system (VRRS) with sensors not connected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Timed Up and Go (TUG) score
Time Frame: baseline (7 days after surgery) and at discharge (28 days after surgery)
The TUG is a timed test used to assess mobility, balance, and walking. The subject must stand up from a chair, walk a distance of 3 meters, turn around, walk back to the chair and sit down - all performed as quickly and as safely as possible.
baseline (7 days after surgery) and at discharge (28 days after surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Hip dysfunction and Osteoarthritis Outcome Score (HOOS)
Time Frame: baseline (7 days after the surgery), at discharge (28 days after surgery) and at 6 months after surgery (by telephone interview)
The HOOS scale scores range from 0 to 100 (0: total hip disability, 100: perfect hip health)
baseline (7 days after the surgery), at discharge (28 days after surgery) and at 6 months after surgery (by telephone interview)
Change in the Numeric Rating Scale for pain (NPRS)
Time Frame: baseline (7 days after surgery), at discharge (28 days after surgery) and at 6 months
A 10-cm Numerical Pain Rating Scale (0: no pain, 10: maximum pain) will be used to assess the current level of hip pain before rehabilitation treatment.
baseline (7 days after surgery), at discharge (28 days after surgery) and at 6 months
Change in the Hip Active Range of Motion
Time Frame: baseline (7 days after surgery) and at discharge (28 days after surgery)
Assessed by goniometer (degree of movement)
baseline (7 days after surgery) and at discharge (28 days after surgery)
Change in the Strength of main muscles of the pelvis and thigh of the affected limb
Time Frame: baseline (7 days after surgery) and at discharge (28 days after surgery)
Assessed by dynamometer
baseline (7 days after surgery) and at discharge (28 days after surgery)
Change in the 6 Minutes Walking Test (6MWT)
Time Frame: baseline (7 days after surgery) and at discharge (28 days after surgery)
Walking ability and cardio-respiratory function
baseline (7 days after surgery) and at discharge (28 days after surgery)
Change in the Short Form Health Survey 36 (SF-36)
Time Frame: baseline (7 days after surgery) and at discharge (28 days after surgery) and at 6 months (telephone interview)
Short Form Health Survey scores range from 0 to 100 (0: maximum disability; 100: no disability)
baseline (7 days after surgery) and at discharge (28 days after surgery) and at 6 months (telephone interview)
Change in the Numeric Rating of Patient Satisfaction with functional outcome
Time Frame: assessed and reported at discharge (28 days after surgery) at 6 months (telephone interview)
A 10-cm Numeric Rating of Patient Satisfaction with the functional outcome (0: no satisfaction; 10: maximum satisfaction) is used to assess the general satisfaction of the patients
assessed and reported at discharge (28 days after surgery) at 6 months (telephone interview)
The drugs assumption for pain management
Time Frame: assessed and reported at discharge (28 days after surgery)
Type of drugs intake for each group during rehabilitation recovery
assessed and reported at discharge (28 days after surgery)

Collaborators and Investigators

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

Sponsor

Mauro Crestani

Investigators

  • Principal Investigator: Mauro Crestani, Azienda ULSS 9 Scaligera

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)

March 15, 2022

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

June 1, 2024

Study Registration Dates

First Submitted

December 8, 2021

First Submitted That Met QC Criteria

December 26, 2021

First Posted (ACTUAL)

December 30, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 30, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AziendaU9S

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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