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

NACompletedINTERVENTIONAL
Enrollment

471

Participants

Timeline

Start Date

March 29, 2022

Primary Completion Date

November 3, 2023

Study Completion Date

November 3, 2023

Conditions
Hip InjuriesFractures, HipFall InjuryFall RiskOsteoporosisOsteoporosis Risk
Interventions
DEVICE

Tango Belt

The Tango Belt is a patient-contacting electronic device made out of medical grade plastics and biocompatible fabrics worn around the waist. The Tango Belt contains a fall-in-progress detection algorithm which can detect a serious hip-impacting fall-in-progress using built-in sensors and deploy an automotive-grade cold-gas airbag to protect the hips from ground impact forces. When connected to Wi-Fi, the Tango Belt can send automated fall and impact alerts to caregivers and Healthcare Providers (HCPs) while recording motion and event data, which can then be analyzed for usage-based metrics viewable via a companion mobile app and/or desktop app. Alerts are sent in the form of short message service (SMS) texts and emails to alert recipients designated in the mobile or desktop Companion App. The Tango Belt can also detect non-serious hip-impacting or non-hip impacting falls in which the wearer may have incurred a minor injury (i.e., not a major hip injury) and/or may be unable to get up.

OTHER

Standard of Care (SOC)

The standard of care (SOC) in the US for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management. The STEADI algorithm consists of tools and resources for healthcare providers for fall risk screening, assessment, and interventioniv,v. Screening and assessment includes identifying fall history and modifiable factors related to fall and fall injury risk (e.g. fear of falling, gait, strength, balance, medications, comorbidities, etc.); then interventions to reduce the fall and fall injury risk are applied based upon assessment findings, and can include physical therapy, medication adjustments, patient education, bed and chair alarms, bed rails, etc.

Trial Locations (10)

17033

Country Meadows Hershey, Hershey

17403

Country Meadows of York-South, York

18940

Chandler Hall Health Services, Newtown

19020

Holy Redeemer Health System, Bensalem

19355

Camilla Hall, Malvern

19436

Foulkeways at Gwynedd, Gwynedd

19446

Meadowood Senior Living, Lansdale

19607

The Heritage of Green Hills, Shillington

19610

Country Meadows Wyomissing, Wyomissing

95831

Revere Court of Sacramento, Sacramento

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Avania

INDUSTRY

lead

ActiveProtective Technologies, Inc

INDUSTRY

NCT05245097 - Mitigation of Major Hip Injury Due to Fall With a Smart Belt | Biotech Hunter | Biotech Hunter