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

Evaluation of the Performance of VRP-Clinic in Healthy Subjects in the Support of Rehabilitation

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.

Study Overview

• Status: Completed
• Conditions: Rehabilitation
• Intervention / Treatment: Other: VRP-Clinic

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VRP-Clinic; VRP-Clinic software on a virtual reality platform	Other: VRP-Clinic; Subjects will perform a series of neck movements guided by graphic instructions appearing in the virtual reality environment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of VRP-Clinic Neck Movements That the Assessing Clinician Recognizes as Rehabilitation Movements	The movements are recorded on video and sent to clinicians for evaluation after the session is completed. The movements are then evaluated by the clinicians according to a predetermined list.	Up to 2 weeks after the session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Any Adverse Event Occurring During the Study	Safety measure - The number of participants with any adverse event reported by the subject or observed by the investigator/clinician during the study will be recorded.	through study completion, an average of 2 weeks

Collaborators and Investigators

• Sponsor: VRHealth Group Ltd
• Collaborators: Shaare Zedek Medical Center
• Investigators: Study Director: Lilach Gavish, PhD, Hebrew University of Jerusalem; Principal Investigator: Yair Barzilay, MD, Shaare Zedek Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2017
• Primary Completion (Actual): July 18, 2017
• Study Completion (Actual): August 10, 2017

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (Actual): April 7, 2017

Study Record Updates

• Last Update Posted (Actual): September 25, 2018
• Last Update Submitted That Met QC Criteria: September 21, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: VRP02-0076-17-SZMC

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
• product manufactured in and exported from the U.S.: No