NCT05173480

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 30, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

March 15, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

1.8 years

First QC Date

December 8, 2021

Last Update Submit

January 30, 2023

Conditions

Total Hip Arthroplasty

Keywords

Virtual reality rehabilitationPhysiotherapyPhysical therapy

Outcome Measures

Primary Outcomes (1)

  • Change in the Timed Up and Go (TUG) score

    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 Outcomes (8)

  • Change in the Hip dysfunction and Osteoarthritis Outcome Score (HOOS)

    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)

    baseline (7 days after surgery), at discharge (28 days after surgery) and at 6 months

  • Change in the Hip Active Range of Motion

    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

    baseline (7 days after surgery) and at discharge (28 days after surgery)

  • Change in the 6 Minutes Walking Test (6MWT)

    baseline (7 days after surgery) and at discharge (28 days after surgery)

  • +3 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

VRRS rehabilitation exercise therapy through a virtual reality rehabilitation system in addition to conventional rehabilitation.

Other: Conventional rehabilitationDevice: Virtual Reality Rehabilitation System (VRRS)

Control group

ACTIVE COMPARATOR

VRRS rehabilitation exercise therapy through a virtual reality rehabilitation system, with sensors not connected, in addition to conventional rehabilitation.

Other: Conventional rehabilitationDevice: Virtual Reality Rehabilitation System (VRRS)

Interventions

Conventional rehabilitationOTHER

Exercise therapy through conventional rehabilitation training made by physiotherapists.

Control groupExperimental group
Virtual Reality Rehabilitation System (VRRS)DEVICE

Exercise therapy through a virtual reality rehabilitation system (VRRS).

Experimental group

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AULSS 9 - Marzana Hospital

Verona, 37142, Italy

RECRUITING

Study Officials

  • Mauro Crestani

    Azienda Ulss 9 Scaligera

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mauro Crestani

CONTACT

3381479872mauro.crestani.93@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 8, 2021

First Posted

December 30, 2021

Study Start

March 15, 2022

Primary Completion

December 31, 2023

Study Completion

June 1, 2024

Last Updated

January 31, 2023

Record last verified: 2023-01

Locations

IT(1)