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

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

Study Overview

• Status: Completed
• Conditions: Hip Disease
• Intervention / Treatment: Other: rehabilitation

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	WOMAC (Western Ontario and McMaster University) Osteoarthritis index	on the 21st day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Galeazzi
• Investigators: Principal Investigator: cristina beretta, MD, istituto galeazzi

Study record dates

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