A Rehabilitation With Virtual Reality in Patients After H... | NCT05001100

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

NCT05001100

Sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Status

Completed

Last Update Posted

Aug 11, 2021Actual

Enrollment

64Actual

Phase

Not Applicable

Conditions

Hip Disease

Interventions

rehabilitation

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 20, 2019Actual

Primary Completion Date

Oct 10, 2020Actual

Completion Date

Nov 7, 2020Actual

First Submitted Date

Jul 29, 2021

First Submission Date that Met QC Criteria

Aug 6, 2021

First Posted Date

Aug 11, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2021

Last Update Posted Date

Aug 11, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
rehabilitation	Other	rehabilitation	Rehabilitation with virtual reality Traditional rehabilitation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- hip arthroplasty

Exclusion Criteria:

patient with resence of neurological and psychiatric disorders
minor patient

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
cristina beretta, MD	istituto galeazzi	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Irccs Istituto Ortopedico Galeazzi		Milan		20133	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012046	Rehabilitation

Ancestor Terms

ID	Term
D000359	Aftercare
D003266	Continuity of Patient Care
D005791	Patient Care
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided