Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:42 PM
Study NCT ID:
NCT07458568
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ViBandz Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-02-05', 'studyFirstSubmitQcDate': '2026-03-05', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'End User System Usability Feedback on ViBandz', 'timeFrame': '3-6 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatrics', 'vibration therapy'], 'conditions': ['Pediatrics', 'Neurologic Dysfunction', 'Vibration Therapy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "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.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (Children):\n\n* Children of ages 6 months to 17 years old\n* Neurologic conditions resulting in abnormal movement of at least one extremity\n* Appointment scheduled in CM PT/OT clinic that would include targeted focal vibration as a standard of care\n\nExclusion Criteria (Children):\n\n* Wards of the state\n\nInclusion Criteria (Parent/LAR):\n\n* Parent or Legally Authorized Representative of a child with inclusion criteria above\n* English-speaking\n\nExclusion Criteria (Parent/LAR):\n\n* Non-English speaking'}, 'identificationModule': {'nctId': 'NCT07458568', 'briefTitle': 'ViBandz Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': 'ViBandz Feasibility Study in the Neurological Pediatric Population', 'orgStudyIdInfo': {'id': 'STUDY00003819'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ViBandz', 'type': 'DEVICE', 'description': "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.\n\nOnce 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."}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'centralContacts': [{'name': 'Megan Blaufuss, OTR/L, MS, CPAM', 'role': 'CONTACT', 'email': 'mmblaufuss@cmh.edu', 'phone': '913-696-5028', 'phoneExt': '85028'}, {'name': 'Ryan Thompson, MS', 'role': 'CONTACT', 'email': 'rmthompson@cmh.edu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Education Coordinator - PTOT', 'investigatorFullName': 'Megan Blaufuss', 'investigatorAffiliation': "Children's Mercy Hospital Kansas City"}}}}