ViBandz Feasibility Study

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.

Study Overview

• Status: Recruiting
• Conditions: Neurologic Dysfunction; Pediatrics; Vibration Therapy
• Intervention / Treatment: Device: ViBandz

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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Megan Blaufuss, OTR/L, MS, CPAM; Phone Number: 85028 913-696-5028; Email: mmblaufuss@cmh.edu
• Study Contact Backup: Name: Ryan Thompson, MS; Email: rmthompson@cmh.edu

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Recruiting
      • Children's Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3-6 months

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: pediatrics; vibration therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurologic Manifestations
• Other Study ID Numbers: STUDY00003819

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No