PediatricsNCT07458568
ViBandz Feasibility Study
An observational study of Pediatrics and Neurologic Dysfunction, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
This is a single site, mixed methods, feasibility study of the ViBandz device at a Midwest pediatric tertiary care hospital in a physical and occupational therapy clinic. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Pediatrics, Neurologic Dysfunction, Vibration Therapy
- What is being tested?
- ViBandz
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 months to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Minimum of 15 children and their parent/LAR (dyad) who have a neurologic condition resulting in abnormal movement of at least one extremity to be enrolled at Children's Mercy Hospital.
Who may be able to join
- Children of ages 6 months to 17 years old
- Neurologic conditions resulting in abnormal movement of at least one extremity
- Appointment scheduled in CM PT/OT clinic that would include targeted focal vibration as a standard of care
- Parent or Legally Authorized Representative of a child with inclusion criteria above
- English-speaking
Who cannot join
- Wards of the state
- Non-English speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ryan Thompson, MS contact
United States1 site, 1 recruiting
- Recruiting
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: ViBandz Feasibility Study in the Neurological Pediatric Population
This is a single site, mixed methods, feasibility study of the ViBandz device at a Midwest pediatric tertiary care hospital in a physical and occupational therapy clinic.
Read the detailed description
This proposal is for a single-site, feasibility study of the use of ViBandz in a treatment population. The analysis is a mixed methods approach with quantitative feedback on surveys and a secondary qualitative review of audio/+/- video that was obtained during the device use. The survey will be done immediately after the study on a device in clinic by the parents. If parents do not have time to finish it then, an email will be sent. Video and audio during the visit will provide additional rich data to understand the device beyond what a standard quantitative survey could provide. Subjects will have their standard clinical care- targeted vibration and then after their visit is completed, they will complete the use of the ViBandz This order will occur with all participants.
- Conditions
- Pediatrics, Neurologic Dysfunction, Vibration Therapy
- Being tested
- ViBandz
- Keywords
- pediatrics, vibration therapy
- Medical subject headings
- Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViBandzDevice
ViBandz is a device with straps and small vibrating motors that can be worn over muscles for stimulation and targeted vibration therapy. It was created to address the need for a hands-free vibrating device. There are different motor sizes and strap sizes for best fit with the patient. ViBandz also features a base station for powering the device and a key fob used to control the vibration therapy.
Once all appropriate signatures have been obtained and all family/subject questions have been addressed, the subject will undergo their scheduled standard clinical Care (SOC) visit. The time with the ViBandz (10-15 minutes) will be less than full traditional targeted therapy (45 minutes) will help to control for subject fatigue as the vibration feeling stimulates muscles.: Video recordings via an iPad or similar device may be obtained during the subject's visit. These videos will allow for a closer inspection of subject interaction with the ViBandz.
What is being measured
The primary outcome is the main question the study is designed to answer.
End User System Usability Feedback on ViBandz
Overall themes to be investigated will include ease of use, perceived comfort in using the ViBandz in the home setting, suggestions for changes/improvements to the ViBandz, and any additional comments. This will be gathered through the use of the System Usability Survey that will be administered via REDCap to parents following use of the ViBandz device for targeted vibration therapy.
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start7 Apr 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan Blaufuss, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458568
- Sponsor's protocol ID
- STUDY00003819
- Status last verified
- Apr 2026
- First submitted
- 5 Feb 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ViBandz Feasibility Study in the Neurological Pediatric Population
- ClinicalTrials.gov ID
- NCT07458568
- Acronym / sponsor ID
- STUDY00003819
- Conditions
- Pediatrics, Neurologic Dysfunction, Vibration Therapy
- Keywords
- pediatrics, vibration therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Mar 2026 (actual)
- 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.
This is a single site, mixed methods, feasibility study of the ViBandz device at a Midwest pediatric tertiary care hospital in a physical and occupational therapy clinic.
Detailed description
This proposal is for a single-site, feasibility study of the use of ViBandz in a treatment population. The analysis is a mixed methods approach with quantitative feedback on surveys and a secondary qualitative review of audio/+/- video that was obtained during the device use. The survey will be done immediately after the study on a device in clinic by the parents. If parents do not have time to finish it then, an email will be sent. Video and audio during the visit will provide additional rich data to understand the device beyond what a standard quantitative survey could provide. Subjects will have their standard clinical care- targeted vibration and then after their visit is completed, they will complete the use of the ViBandz This order will occur with all participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Minimum of 15 children and their parent/LAR (dyad) who have a neurologic condition resulting in abnormal movement of at least one extremity to be enrolled at Children's Mercy Hospital.
Key inclusion criteria (5 listed)
- Children of ages 6 months to 17 years old
- Neurologic conditions resulting in abnormal movement of at least one extremity
- Appointment scheduled in CM PT/OT clinic that would include targeted focal vibration as a standard of care
- Parent or Legally Authorized Representative of a child with inclusion criteria above
- English-speaking
Key exclusion criteria (2 listed)
- Wards of the state
- Non-English speaking
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 |
|---|---|---|
| ViBandzViBandz is a device with straps and small vibrating motors that can be worn over muscles for stimulation and targeted vibration therapy. It was created to address the need for a hands-free vibrating device. There are different motor sizes and strap sizes for best fit with the patient. ViBandz also features a base station for powering the device and a key fob used to control the vibration therapy. Once all appropriate signatures have been obtained and all family/subject questions have been addressed, the subject will undergo their scheduled standard clinical Care (SOC) visit. The time with the ViBandz (10-15 minutes) will be less than full traditional targeted therapy (45 minutes) will help to control for subject fatigue as the vibration feeling stimulates muscles.: Video recordings via an iPad or similar device may be obtained during the subject's visit. These videos will allow for a closer inspection of subject interaction with the ViBandz. | Device | – |
Primary outcome
End User System Usability Feedback on ViBandz
Time frame: 3-6 months
Overall themes to be investigated will include ease of use, perceived comfort in using the ViBandz in the home setting, suggestions for changes/improvements to the ViBandz, and any additional comments. This will be gathered through the use of the System Usability Survey that will be administered via REDCap to parents following use of the ViBandz device for targeted vibration therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- 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.
Ryan Thompson, MS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatrics and Neurologic Dysfunction, run by Children's Mercy Hospital Kansas City at 1 site 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 Apr 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Blaufuss, OTR/L, MS, CPAM (913-696-5028 ext. 85028, mmblaufuss@cmh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End User System Usability Feedback on ViBandz (time frame: 3-6 months). 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 27 Apr 2026.