ViBandz Feasibility Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-17
SponsorChildren's Mercy Hospital Kansas City
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Wards of the state
Parent or Legally Authorized Representative of a child with inclusion criteria above
English-speaking
Non-English speaking
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
ViBandz
DeviceViBandz 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.
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
3-6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov