Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Location status: Recruiting
NCT Number: NCT07458568
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.
Interested in participating?
Request Info6 month–17 year
All sexes
Observational
Kansas City, Missouri, 64108, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(Children):
Exclusion criteria
(Children):
Inclusion criteria
(Parent/LAR):
Exclusion criteria
(Parent/LAR):
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.
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.
Contact information is provided by the study sponsor or research team.
Children's Mercy Hospital Kansas City
Other
ViBandz Feasibility Study in the Neurological Pediatric Population
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.
Published trials that share one or more normalized conditions with this study.
NCT07182474
Congenital Abnormalities, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Kahramanmaraş, Onikişubat, Turkey (Türkiye)
View Trial DetailsNCT03986021
Adolescent Development, Adolescent Health
Research Triangle Park, North Carolina, United States
View Trial DetailsNCT07319273
Anxiety Disorders, Hypersensitivity
Shanghai, China
View Trial DetailsNCT06235125
Fluorescence, Metastatic Sarcoma
Chicago, Illinois, United States
View Trial Details