ViBandz Feasibility Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ViBandz.
- Who it may be relevant to
- Registry conditions: Pediatrics, Neurologic Dysfunction, Vibration Therapy. Basic parameters: 6 months — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
ViBandz Feasibility Study in the Neurological Pediatric Population
Overview
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.
Interventions
- Device ViBandz
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 addre
Primary outcome measures
- End User System Usability Feedback on ViBandz [Time frame: 3-6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Children's Mercy Hospital — Kansas City
Identifiers
NCT: NCT07458568 · STUDY00003819