Mitigation of Major Hip Injury Due to Fall With a Smart Belt

This is an interventional prevention trial for Hip Injuries focused on measuring Fall risk, Fall injury, Major hip injury, Hip fracture Read More

Inclusion Criteria:

1. Age 65 years or older;
2. 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.
3. 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);
4. Have a waist circumference between 29 - 50 inches (63.5 - 127 cm);
5. Able to comply with required study procedures and follow-up schedule as determined by the Study Investigator;
6. Are under the care of the Investigational organization;
7. Provides consent or their legally authorized representative provides consent on subject's behalf

Exclusion Criteria:

1. Age 64 years or less;
2. Participation in a different clinical investigation that can conflict with this clinical study as determined by the Study Investigator and approved by the Sponsor;
3. 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;
4. Use of other devices or interventions outside of SOC (Standard of care) for fall risk management during study participation without Sponsor approval;
5. Unable to comply with required study procedures and follow-up schedule as determined by the Study Investigator;
6. Does not provide consent, or legally authorized representative does not provide consent