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

Completed · Not applicable

Conditions studied: Hip Injuries, Fractures, Hip, Fall Injury, Fall Risk, Osteoporosis, Osteoporosis Risk

In brief

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.

Key facts

Study ID

NCT05245097

Run by

ActiveProtective Technologies, Inc

People needed

471

Starts

2022-03-29

Expected to finish

2023-11-03

Last updated by the study team

2025-06-13

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Revere Court of Sacramento — Sacramento, California, United States
• Holy Redeemer Health System — Bensalem, Pennsylvania, United States
• Foulkeways at Gwynedd — Gwynedd, Pennsylvania, United States
• Country Meadows Hershey — Hershey, Pennsylvania, United States
• Meadowood Senior Living — Lansdale, Pennsylvania, United States
• Camilla Hall — Malvern, Pennsylvania, United States
• Chandler Hall Health Services — Newtown, Pennsylvania, United States
• The Heritage of Green Hills — Shillington, Pennsylvania, United States
• Country Meadows Wyomissing — Wyomissing, Pennsylvania, United States
• Country Meadows of York-South — York, Pennsylvania, United States

Full record on ClinicalTrials.gov

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