Status:
COMPLETED
Mitigation of Major Hip Injury Due to Fall With a Smart Belt
Lead Sponsor:
ActiveProtective Technologies, Inc
Collaborating Sponsors:
Avania
Conditions:
Hip Injuries
Fractures, Hip
Eligibility:
All Genders
65+ years
Phase:
NA
Brief 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 prescrib...
Detailed Description
This is a multi-center, comparative, adaptive, non-significant risk clinical trial conducted in the United States to assess the safety and efficacy of the Tango Belt within senior care settings. Effec...
Eligibility Criteria
Inclusion
- 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
- Age 64 years or less;
- 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
Key Trial Info
Start Date :
March 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2023
Estimated Enrollment :
471 Patients enrolled
Trial Details
Trial ID
NCT05245097
Start Date
March 29 2022
End Date
November 3 2023
Last Update
June 13 2025
Active Locations (10)
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1
Revere Court of Sacramento
Sacramento, California, United States, 95831
2
Holy Redeemer Health System
Bensalem, Pennsylvania, United States, 19020
3
Foulkeways at Gwynedd
Gwynedd, Pennsylvania, United States, 19436
4
Country Meadows Hershey
Hershey, Pennsylvania, United States, 17033