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

Rehabilitation Clinical Trial

— VRP02  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03104647
• Other study ID #: VRP02-0076-17-SZMC
• Status: Completed
• Phase: N/A
• Start date: July 3, 2017
• Est. completion date: August 10, 2017

Study information

• Verified date: September 2018
• Source: VRHealth Group Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 10, 2017
• Est. primary completion date: July 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Rehabilitation

Intervention

Other:
• VRP-Clinic
Subjects will perform a series of neck movements guided by graphic instructions appearing in the virtual reality environment

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
VRHealth Group Ltd	Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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