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NCT Number: NCT07458568

ViBandz Feasibility Study

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.

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Key information

Age range

6 month–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Children):

  • 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

Exclusion criteria

(Children):

  • Wards of the state

Inclusion criteria

(Parent/LAR):

  • Parent or Legally Authorized Representative of a child with inclusion criteria above
  • English-speaking

Exclusion criteria

(Parent/LAR):

  • Non-English speaking

Treatment and study plan

ViBandz

Device

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Megan Blaufuss, OTR/L, MS, CPAM

CONTACT

[email protected]

913-696-5028 ext. 85028

Ryan Thompson, MS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Official study title

ViBandz Feasibility Study in the Neurological Pediatric Population

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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