Physical RehabilitationNCT02373748
Performance of the BioGaming Device (YuGo) in the Support of Physical Rehabilitation
A study testing BioGaming YuGo System in people with Physical Rehabilitation, run by BioGaming Ltd. at 1 site in Israel.
Trial summary
The purpose of this study is to evaluate the movements performed according to the BioGaming YuGo software, and verify that they are rehabilitation movements. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Rehabilitation
- What is being tested?
- BioGaming YuGo System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2015to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject is willing to comply with protocol-specified evaluations
- Subject signed informed consent
Who cannot join
- Pregnant or nursing female subjects
- Surgical procedures or injuries to the extremities that could potentially affect physical functions
- Neurological and/or vestibular disease
- Cognitive impairment
- Subjects taking any prescribed drugs that could potentially affect physical function and balance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single Site, Single-arm Study Designed to Evaluate the Performance of the BioGaming Device (YuGo) in the Support of Physical Rehabilitation
The purpose of this study is to evaluate the movements performed according to the BioGaming YuGo software, and verify that they are rehabilitation movements.
- Conditions
- Physical Rehabilitation
- Being tested
- BioGaming YuGo System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioGaming YuGo SystemDevice
Subjects will perform a customized training program predefined in the BioGaming YuGo system.
| Study group | Role | What they receive |
|---|---|---|
| BioGaming YuGo System | Experimental | Not described Receives: Device: BioGaming YuGo System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of BioGaming YuGo activity movements which are clinician recognized rehabilitation movements.
Activity movements are assessed by independent clinicians.
Measured: Baseline procedure
Secondary outcomes (1)
Safety - Record of any adverse event
Any adverse event occurring during the baseline procedure will be recorded.
Measured: Baseline procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioGaming Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373748
- Sponsor's protocol ID
- 111CLD
- Status last verified
- Jun 2015
- First submitted
- 17 Feb 2015
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Site, Single-arm Study Designed to Evaluate the Performance of the BioGaming Device (YuGo) in the Support of Physical Rehabilitation
- ClinicalTrials.gov ID
- NCT02373748
- Acronym / sponsor ID
- 111CLD
- Conditions
- Physical Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BioGaming Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 27 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the movements performed according to the BioGaming YuGo software, and verify that they are rehabilitation movements.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BioGaming YuGo System | Experimental | Device: BioGaming YuGo System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The subject is willing to comply with protocol-specified evaluations
- Subject signed informed consent
Key exclusion criteria (5 listed)
- Pregnant or nursing female subjects
- Surgical procedures or injuries to the extremities that could potentially affect physical functions
- Neurological and/or vestibular disease
- Cognitive impairment
- Subjects taking any prescribed drugs that could potentially affect physical function and balance
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 |
|---|---|---|
| BioGaming YuGo SystemSubjects will perform a customized training program predefined in the BioGaming YuGo system. | Device | BioGaming YuGo System |
Primary outcome
Number of BioGaming YuGo activity movements which are clinician recognized rehabilitation movements.
Time frame: Baseline procedure
Activity movements are assessed by independent clinicians.
1 secondary outcome
Safety - Record of any adverse event
Time frame: Baseline procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioGaming YuGo System in people with Physical Rehabilitation, run by BioGaming 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 5 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 4 Jun 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 BioGaming YuGo activity movements which are clinician recognized rehabilitation movements. (time frame: Baseline procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2015.