NCT07458568

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
7mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Apr 2026Dec 2026

First Submitted

Initial submission to the registry

February 5, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

April 7, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

February 5, 2026

Last Update Submit

April 22, 2026

Conditions

Keywords

pediatricsvibration therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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.

Eligibility Criteria

Age6 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Wards of the state
  • English-speaking
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

RECRUITING

MeSH Terms

Conditions

Neurologic Manifestations

Condition Hierarchy (Ancestors)

Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Megan Blaufuss, OTR/L, MS, CPAM

CONTACT

Ryan Thompson, MS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Education Coordinator - PTOT

Study Record Dates

First Submitted

February 5, 2026

First Posted

March 9, 2026

Study Start

April 7, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations