Trial Outcomes & Findings for VRP-Clinic Software Evaluation - in Support of Rehabilitation (VRP02) (NCT NCT03104647)

NCT ID: NCT03104647

Last Updated: 2018-09-25

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Up to 2 weeks after the session
• Results posted on: 2018-09-25

Participant Flow

Recruitment took place at the Shaare ZedeK Medical Center during the 5th of July 2017.

Participant milestones

Measure	VRP-Clinic VRP-Clinic software on a virtual reality platform VRP-Clinic: Subjects will perform a series of neck movements guided by graphic instructions appearing in the virtual reality environment
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	VRP-Clinic n=20 Participants VRP-Clinic software on a virtual reality platform VRP-Clinic: Subjects will perform a series of neck movements guided by graphic instructions appearing in the virtual reality environment
Age, Categorical <=18 years	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=20 Participants
Age, Categorical >=65 years	0 Participants n=20 Participants
Age, Continuous	38 years STANDARD_DEVIATION 14 • n=20 Participants
Sex: Female, Male Female	7 Participants n=20 Participants
Sex: Female, Male Male	13 Participants n=20 Participants
Region of Enrollment Israel	20 participants n=20 Participants

PRIMARY outcome

Timeframe: Up to 2 weeks after the session

Population: Each subject performed 8 movements and repeated them twice. Overall, 160 movements were performed by 20 subjects and repeated twice. The clinicians recognized all the movements and determined them 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.

Outcome measures

Measure	VRP-Clinic n=320 Movements VRP-Clinic software on a virtual reality platform VRP-Clinic: Subjects will perform a series of neck movements guided by graphic instructions appearing in the virtual reality environment
Number of VRP-Clinic Neck Movements That the Assessing Clinician Recognizes as Rehabilitation Movements	320 Movements

SECONDARY outcome

Timeframe: through study completion, an average of 2 weeks

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.

Outcome measures

Measure	VRP-Clinic n=20 Participants VRP-Clinic software on a virtual reality platform VRP-Clinic: Subjects will perform a series of neck movements guided by graphic instructions appearing in the virtual reality environment
Number of Participants With Any Adverse Event Occurring During the Study	0 participants

Adverse Events

VRP-Clinic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Yair Barzilay, PI

Shaare Zedek Medical Center

Phone: +972-2-6555166

Email: barzilay@szmc.org.il

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place