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

A study testing VRP-Clinic in people with Rehabilitation, run by VRHealth Group Ltd at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Rehabilitation
What is being tested?: VRP-Clinic
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteIsrael
Study dates: 3 Jul 2017to 10 Aug 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy male or female
Age 18-65

Who cannot join

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

Show all 9Show fewer

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)

Trial locations and contacts

1 site in 1 country.

Israel1 site

Shaare Zedek Medical Center
Jerusalem, 9103102

Other trials in Israel

About this study

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

Read the 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.

Conditions: Rehabilitation
Being tested: VRP-Clinic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03104647
Study group	Role	What they receive
VRP-Clinic	Experimental	VRP-Clinic software on a virtual reality platform Receives: Other: VRP-Clinic

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 2 weeks after the session

Secondary outcomes (1)

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.
Measured: through study completion, an average of 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jul 201710 Aug 2017

First posted7 Apr 2017
Study start3 Jul 2017
Primary completion18 Jul 2017
Study completion10 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for RehabilitationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03104647
Sponsor's protocol ID: VRP02-0076-17-SZMC
Acronym: VRP02
Status last verified: Sep 2018
First submitted: 3 Apr 2017
Last updated: 25 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Performance of VRP-Clinic in Healthy Subjects in the Support of Rehabilitation
ClinicalTrials.gov ID: NCT03104647
Acronym / sponsor ID: VRP02 / VRP02-0076-17-SZMC
Conditions: Rehabilitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: VRHealth Group LtdIndustry (pharma, biotech, devices)
Collaborators: Shaare Zedek Medical Center
Study start: 3 Jul 2017 (actual)
Primary completion: 18 Jul 2017 (actual)
Study completion: 10 Aug 2017 (actual)
First posted: 7 Apr 2017 (actual)
Results: Posted 25 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study will take place at Shaare Zedek Medical Center (SZMC). The study will include a single visit.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
VRP-Clinic	Experimental	Other: VRP-ClinicVRP-Clinic software on a virtual reality platform

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Healthy male or female
Age 18-65

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VRP-ClinicSubjects will perform a series of neck movements guided by graphic instructions appearing in the virtual reality environment	Other	VRP-Clinic

Primary outcome

Number of VRP-Clinic Neck Movements That the Assessing Clinician Recognizes as Rehabilitation Movements
Time frame: 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.

1 secondary outcome

Number of Participants With Any Adverse Event Occurring During the Study
Time frame: through study completion, an average of 2 weeks

Results and safety

Results posted to the registry on 25 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VRP-Clinic	20	20

Primary outcome: Number of VRP-Clinic Neck Movements That the Assessing Clinician Recognizes as Rehabilitation Movements

Time frame: Up to 2 weeks after the session. Number. Unit: Movements

Measure	VRP-Clinic n = 20
Value	320

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: This was a single visit study with no follow up. The adverse event data was collected on the day of the visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VRP-Clinic	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yair Barzilay, MD principal investigator

Shaare Zedek Medical Center

Lilach Gavish, PhD study director

Hebrew University of Jerusalem

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing VRP-Clinic in people with Rehabilitation, run by VRHealth Group Ltd at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of VRP-Clinic Neck Movements That the Assessing Clinician Recognizes as Rehabilitation Movements (time frame: Up to 2 weeks after the session). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03104647.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2018.