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
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2017
CompletedFirst Posted
Study publicly available on registry
April 7, 2017
CompletedStudy Start
First participant enrolled
July 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2017
CompletedResults Posted
Study results publicly available
September 25, 2018
CompletedSeptember 25, 2018
September 1, 2018
15 days
April 3, 2017
August 29, 2017
September 21, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of Participants With Any Adverse Event Occurring During the Study
through study completion, an average of 2 weeks
Study Arms (1)
VRP-Clinic
EXPERIMENTALVRP-Clinic software on a virtual reality platform
Interventions
Subjects will perform a series of neck movements guided by graphic instructions appearing in the virtual reality environment
Eligibility Criteria
You may qualify if:
- Healthy male or female
- Age 18-65
You may not qualify if:
- History of neck related disorders (Whiplash, disc degeneration disease or other acute cervical spine conditions)
- Current neck pain
- Under medical treatment or observation for any health-related issue during the study
- Recent trauma
- Oncology background
- Acute disease/illness
- Pregnancy.
- Using drugs that could potentially affect physical function and balance (such as corticosteroids, antipsychotics or antidepressants)
- Vision problems that require glasses (not all frame types can fit into the headset)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VRHealth Group Ltdlead
- Shaare Zedek Medical Centercollaborator
Study Sites (1)
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Results Point of Contact
- Title
- Dr. Yair Barzilay, PI
- Organization
- Shaare Zedek Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Yair Barzilay, MD
Shaare Zedek Medical Center
- STUDY DIRECTOR
Lilach Gavish, PhD
Hebrew University of Jerusalem
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2017
First Posted
April 7, 2017
Study Start
July 3, 2017
Primary Completion
July 18, 2017
Study Completion
August 10, 2017
Last Updated
September 25, 2018
Results First Posted
September 25, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share