Rehabilitation
Conditions
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.
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.
Interventions
OTHERVRP-Clinic
Subjects will perform a series of neck movements guided by graphic instructions appearing in the virtual reality environment
Sponsors
Shaare Zedek Medical Center
VRHealth Group Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of VRP-Clinic Neck Movements That the Assessing Clinician Recognizes as Rehabilitation Movements | Up to 2 weeks after the session | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Adverse Event Occurring During the Study | 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. |
Countries
Israel
Participant flow
Recruitment details
Recruitment took place at the Shaare ZedeK Medical Center during the 5th of July 2017.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | VRP-Clinic | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 20 Participants | — |
| Age, Continuous | 38 years STANDARD_DEVIATION 14 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Israel | 20 participants | — |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 13 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VRP-Clinic | Number of VRP-Clinic Neck Movements That the Assessing Clinician Recognizes as Rehabilitation Movements | 320 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.
Time frame: through study completion, an average of 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VRP-Clinic | Number of Participants With Any Adverse Event Occurring During the Study | 0 participants |