Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shaare Zedek Medical Center | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VRP-Clinic | Experimental | VRP-Clinic software on a virtual reality platform |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VRP-Clinic | Other | Subjects will perform a series of neck movements guided by graphic instructions appearing in the virtual reality environment |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yair Barzilay, MD | Shaare Zedek Medical Center | Principal Investigator |
| Lilach Gavish, PhD | Hebrew University of Jerusalem | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Recruitment took place at the Shaare ZedeK Medical Center during the 5th of July 2017.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | Movements | Up to 2 weeks after the session | Movements | Movements |
|
This was a single visit study with no follow up. The adverse event data was collected on the day of the visit.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yair Barzilay, PI | Shaare Zedek Medical Center | +972-2-6555166 | barzilay@szmc.org.il |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 22, 2017 | Aug 29, 2017 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Movements |
|
|
| 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. | Posted | Number | participants | through study completion, an average of 2 weeks |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
Not provided
Not provided