VRP-Clinic Software Evaluation - in Support of Rehabilitation (VRP02)

NCT ID: NCT03104647

Last Updated: 2018-09-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-03

Study Completion Date

2017-08-10

Brief Summary

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The current study is designed to evaluate neck movements performed according to the VRP-Clinic software, and to verify that they promote physical activities that correspond with physical rehabilitation.

Detailed Description

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The study will take place at Shaare Zedek Medical Center (SZMC). The study will include a single visit.

Each subject will put on the VR headset and perform a series of neck movements guided by graphic instructions appearing in the VR environment. The session will be recorded with a video camera which will subsequently be viewed and evaluated by clinicians. The clinicians will identify each movement seen on the video from a predefined list and determine if such a movement is recommended as part of a rehabilitation training program.

Conditions

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Rehabilitation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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VRP-Clinic

VRP-Clinic software on a virtual reality platform

Group Type EXPERIMENTAL

VRP-Clinic

Intervention Type OTHER

Subjects will perform a series of neck movements guided by graphic instructions appearing in the virtual reality environment

Interventions

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VRP-Clinic

Subjects will perform a series of neck movements guided by graphic instructions appearing in the virtual reality environment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Healthy male or female
2. Age 18-65

Exclusion Criteria

1. History of neck related disorders (Whiplash, disc degeneration disease or other acute cervical spine conditions)
2. Current neck pain
3. Under medical treatment or observation for any health-related issue during the study
4. Recent trauma
5. Oncology background
6. Acute disease/illness
7. Pregnancy.
8. Using drugs that could potentially affect physical function and balance (such as corticosteroids, antipsychotics or antidepressants)
9. Vision problems that require glasses (not all frame types can fit into the headset)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role collaborator

VRHealth Group Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yair Barzilay, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center

Lilach Gavish, PhD

Role: STUDY_DIRECTOR

Hebrew University of Jerusalem

Locations

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Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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VRP02-0076-17-SZMC

Identifier Type: -

Identifier Source: org_study_id

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