Mitigation of Major Hip Injury Due to Fall With a Smart Belt (NCT05245097) | Clinical Trial Compass
CompletedNot Applicable
Mitigation of Major Hip Injury Due to Fall With a Smart Belt
United States471 participantsStarted 2022-03-29
Plain-language summary
Multi-center, comparative, non-significant risk adaptive study with retrospective controls.
After providing informed consent and being screened for eligibility, intervention subjects will be prescribed and provided an appropriately sized Tango Belt. The subject must demonstrate a minimum of 64% adherence to the use of the Tango Belt within 14 days of initiation to fully enroll in the study. Upon demonstration of at least minimum adherence, the subject will be provided the Tango Belt to wear continuously for at least 6 months, except during bathing, device charging, and as deemed by clinical staff.
The study will investigate the safety and effectiveness of the Tango Belt with the primary and secondary endpoints being taken every 3 months and at the end of the study run time from the electronic medical record. Additionally, ancillary endpoints on adverse events and device performance will be gathered.
Who can participate
Age range65 Years
SexALL
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Inclusion criteria
✓. Age 65 years or older;
✓. Have experienced a fall-related fracture after age 50 -OR- Have experienced one or more falls in the 12-months prior to consent and have a diagnosis of osteoporosis, osteopenia, or prescribed osteoporosis medication.
✓. Independently or with staff or caregiver assistance, able to transfer between surfaces (e.g., to or from a bed, chair, wheelchair, toilet, standing position) or walk or move between locations (use of an assistive device such as a walker is acceptable);
✓. Have a waist circumference between 29 - 50 inches (63.5 - 127 cm);
✓. Able to comply with required study procedures and follow-up schedule as determined by the Study Investigator;
✓. Are under the care of the Investigational organization;
✓. Provides consent or their legally authorized representative provides consent on subject's behalf
Exclusion criteria
✕. Age 64 years or less;
What they're measuring
1
Major Hip Injuries Due to Serious Hip-impacting Fall
. Participation in a different clinical investigation that can conflict with this clinical study as determined by the Study Investigator and approved by the Sponsor;
✕. Total dependence on staff or caregiver assistance to be able to transfer between surfaces (e.g., to or from a bed, chair, wheelchair, toilet, standing position) and walk and move between locations;
✕. Use of other devices or interventions outside of SOC (Standard of care) for fall risk management during study participation without Sponsor approval;
✕. Unable to comply with required study procedures and follow-up schedule as determined by the Study Investigator;
✕. Does not provide consent, or legally authorized representative does not provide consent