Disability PhysicalNCT03714256
Human Factor Validation of Pediatric Mobility Device
A study testing Device, patient mobility, powered in people with Disability Physical, run by Permobil, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to validate the user interface of a pediatric power mobility device by establishing that the product is safe and effective use for the intended users. Read more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Disability Physical
- What is being tested?
- Device, patient mobility, powered
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Sep 2018to 19 Nov 2018
- 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 6 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Primary users:
- Informed consent signed by parents or guardian
- Aged 6-36 months
- Unable to mobilize independently for exploratory play and peer interaction, as categorized by Hays (1987)
- Adequate trunk and head control to remain upright in the device, including regain head control
- Adequate hand/ arm (distal) control to reach for objects in front of them
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- Secondary users:
- Signed informed consent
- Physiotherapist/Occupational Therapist or parent/guardian of the child included in the test
Who cannot join
- Primary users:
- Weight >16 kg/35 Ibs
- Length >100 cm/39 In
- Children that lack head control in such a severe manner that they cannot regain control if it is lost
- Children who do not show awareness of or respond to toys, objects, sounds and/or people in their environment
- Any other reason, if in the opinion of the investigator, the individual user is not appropriate, or suitable for participation in the test.
Show all 10Show fewer
- Secondary users:
- Hearing/vision loss or limited cognitive skills impacting the ability to take instructions and perform the tasks of the test
- Ability to understand oral and written English as product labelling will in this Human Factor validation test only be available in English
- Any other reason, if in the opinion of the investigator, the individual user is not appropriate, or suitable for participation in the test
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
Oregon State University
Corvallis, Oregon, 97331
Belmont University
Nashville, Tennessee, 37212
About this study
The purpose of this study is to validate the user interface of a pediatric power mobility device by establishing that the product is safe and effective use for the intended users.
Read the detailed description
The purpose of this study is to validate the user interface of a pediatric power mobility device by establishing that the product is safe and effective use for the intended users. The human factors validation study will be conducted in children with mobility impairments as categorised by Hays (1987) in the age range of 6 months to 36 months under realistic use conditions.The study is an open label, un-blinded, non-randomized study which consists of one visit.
- Conditions
- Disability Physical
- Being tested
- Device, patient mobility, powered
- Keywords
- Pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device, patient mobility, poweredDevice
Pediatric mobility device
| Study group | Role | What they receive |
|---|---|---|
| Children 6-17 months | Experimental | Device, patient mobility, powered:
Usability of the pediatric mobility device by both parent/guardian and occupational/physiological therapist, performed according to instructions for use at a one time occasion. Receives: Device: Device, patient mobility, powered |
| Children 18 - 36 months | Experimental | Device, patient mobility, powered:
Usability of the pediatric mobility device by both parent/guardian and occupational/physiological therapist, performed according to instructions for use at a one time occasion. Receives: Device: Device, patient mobility, powered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Number of Use Errors Associated With the Usage of the Device According to Labelling
The tasks in this Human factors validation test, that will be performed by the users are: charge battery and disconnect it, adjust seat and table height, adjust the speed, place the child in device, adjust cushion and other support. The summary of identified errors, captured through observation and interview, will be counted and define the primary outcome
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start21 Sep 2018
- Primary completion19 Nov 2018
- Study completion19 Nov 2018
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 Disability PhysicalStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Permobil, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karin Leire, Study director, Permobil Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714256
- Sponsor's protocol ID
- Per2018P04
- Status last verified
- Jan 2021
- First submitted
- 11 Oct 2018
- Last updated
- 14 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Factor Validation of Pediatric Mobility Device
- ClinicalTrials.gov ID
- NCT03714256
- Acronym / sponsor ID
- Per2018P04
- Conditions
- Disability Physical
- Keywords
- Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Permobil, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 19 Nov 2018 (actual)
- Study completion
- 19 Nov 2018 (actual)
- First posted
- 22 Oct 2018 (actual)
- Results
- Posted 14 Jan 2021
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 validate the user interface of a pediatric power mobility device by establishing that the product is safe and effective use for the intended users.
Detailed description
The purpose of this study is to validate the user interface of a pediatric power mobility device by establishing that the product is safe and effective use for the intended users. The human factors validation study will be conducted in children with mobility impairments as categorised by Hays (1987) in the age range of 6 months to 36 months under realistic use conditions.The study is an open label, un-blinded, non-randomized study which consists of one visit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children 6-17 months | Experimental | Device: Device, patient mobility, poweredDevice, patient mobility, powered: Usability of the pediatric mobility device by both parent/guardian and occupational/physiological therapist, performed according to instructions for use at a one time occasion. |
| Children 18 - 36 months | Experimental | Device: Device, patient mobility, poweredDevice, patient mobility, powered: Usability of the pediatric mobility device by both parent/guardian and occupational/physiological therapist, performed according to instructions for use at a one time occasion. |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Informed consent signed by parents or guardian
- Aged 6-36 months
- Unable to mobilize independently for exploratory play and peer interaction, as categorized by Hays (1987)
- Adequate trunk and head control to remain upright in the device, including regain head control
- Adequate hand/ arm (distal) control to reach for objects in front of them
Key exclusion criteria (10 listed)
- Primary users:
- Hearing/vision loss or limited cognitive skills impacting the ability to take instructions and perform the tasks of the test
- Ability to understand oral and written English as product labelling will in this Human Factor validation test only be available in English
- Any other reason, if in the opinion of the investigator, the individual user is not appropriate, or suitable for participation in the test
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 |
|---|---|---|
| Device, patient mobility, poweredPediatric mobility device | Device | Children 18 - 36 months, Children 6-17 months |
Primary outcome
Cumulative Number of Use Errors Associated With the Usage of the Device According to Labelling
Time frame: One day
The tasks in this Human factors validation test, that will be performed by the users are: charge battery and disconnect it, adjust seat and table height, adjust the speed, place the child in device, adjust cushion and other support. The summary of identified errors, captured through observation and interview, will be counted and define the primary outcome
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- 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.
Karin Leire study director
Permobil Group
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device, patient mobility, powered in people with Disability Physical, run by Permobil, Inc. at 3 sites in United States.
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 9 inclusion and 10 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 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 14 Jan 2021). 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?
Cumulative Number of Use Errors Associated With the Usage of the Device According to Labelling (time frame: One day). 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 14 Jan 2021.