NCT05245097Completed
Mitigation of Major Hip Injury Due to Fall With a Smart Belt
Mitigation of Major Hip Injury Due to Fall in an At-Risk, Older Adult Population With a Wearable Smart Belt
Source: ClinicalTrials.gov · Last updated 13 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 471 (actual)
- First submitted
- 29 Jan 2022
- Start date
- 29 Mar 2022
- Primary completion date
- 3 Nov 2023
- Lead sponsor
- ActiveProtective Technologies, Inc
- Diseases
- Osteoporosis
- NCT number
- NCT05245097
What you commit to
- Study type: Interventional
- Participants enrolled: 471
- From 29 Mar 2022 to the primary completion date, 3 Nov 2023
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Age 64 years or less;
Other
- 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
Who the study is looking for
- 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
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Holy Redeemer Health System Coordinator of this site? Confirm its status | Bensalem | United States | Unknown status |
| Foulkeways at Gwynedd Coordinator of this site? Confirm its status | Gwynedd | United States | Unknown status |
| Country Meadows Hershey Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
| Meadowood Senior Living Coordinator of this site? Confirm its status | Lansdale | United States | Unknown status |
| Camilla Hall Coordinator of this site? Confirm its status | Malvern | United States | Unknown status |
| Chandler Hall Health Services Coordinator of this site? Confirm its status | Newtown | United States | Unknown status |
| Revere Court of Sacramento Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| The Heritage of Green Hills Coordinator of this site? Confirm its status | Shillington | United States | Unknown status |
| Country Meadows Wyomissing Coordinator of this site? Confirm its status | Wyomissing | United States | Unknown status |
| Country Meadows of York-South Coordinator of this site? Confirm its status | York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.