NCT05001100

Brief Summary

.Assessing efficacy of rehabilitation with virtual reality exercises compared to traditional rehabilitation in the patient's operated hip arthroplasty

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 20, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2020

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 11, 2021

Completed
Last Updated

August 11, 2021

Status Verified

July 1, 2021

Enrollment Period

1.7 years

First QC Date

July 29, 2021

Last Update Submit

August 6, 2021

Conditions

Hip Disease

Outcome Measures

Primary Outcomes (1)

  • disability measurement

    WOMAC (Western Ontario and McMaster University) Osteoarthritis index

    on the 21st day

Secondary Outcomes (1)

  • pain measurement

    on the 10st day

Study Arms (2)

Traditional rehabilitation

ACTIVE COMPARATOR

32 subjects will undergo a virtual motor-reality training during the post-surgical rehabilitation period with VRSS

Other: rehabilitation

Rehabilitation with virtual reality

EXPERIMENTAL

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

Other: rehabilitation

Interventions

rehabilitationOTHER

rehabilitation

Rehabilitation with virtual realityTraditional rehabilitation

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- hip arthroplasty

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irccs Istituto Ortopedico Galeazzi

Milan, 20133, Italy

Location

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • cristina beretta, MD

    istituto galeazzi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2021

First Posted

August 11, 2021

Study Start

January 20, 2019

Primary Completion

October 10, 2020

Study Completion

November 7, 2020

Last Updated

August 11, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)