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

NCT05245097 | Completed Results FDA Device

• 1 other identifier: COP-0001
• Study Type: interventional
• Target: 471
• Locations: 1 country
• Sites: 10

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 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.

Conditions

Hip Injuries; Fractures, Hip; Fall Injury; Fall Risk; Osteoporosis; Osteoporosis Risk

Keywords

Fall risk; Fall injury; Major hip injury; Hip fracture

Outcome Measures

Primary Outcomes (1)

• Major Hip Injuries Due to Serious Hip-impacting Fall

  The percent of subjects in the ITT population with major hip injuries due to serious hip-impacting falls.

  6 months

Secondary Outcomes (3)

• Number of Hip Fractures Related to Fall

  6 months

• Number of Emergency Department Visits Related to Fall

  6 months

• Number of Hospitalizations Due to Fall

  6 months

Other Outcomes (8)

• Number and Severity of Adverse Events

  6 months

• Number of Major Injuries Due to Fall

  6 months

• Rate of Fall Occurence

  6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group will be assigned a Tango Belt to be worn around the waist for up to 24 hours a day (removed for bathing, charging of device and upon request) for 6 months. The Tango Belt (the "Device") is a wearable belt designed to enable safer mobility of geriatric individuals (≥ 65 years of age) at risk for fall injury by mitigating major hip injuries due to falls by deploying an airbag around the hips upon sensing a serious hip-impacting fall-in-progress to protect the hips from ground impact forces.

Device: Tango Belt; Other: Standard of Care (SOC)

Control Group

OTHER

The clinical site's electronic medical record (EMR) database will be reviewed determine their long-term care patient population's initial eligibility for meeting the study inclusion criteria beginning at the time frame 6 months prior to the institutional review board (IRB) approval date. Subjects eligible for the control group must meet the requirements of the inclusion and exclusion criteria except for the waist circumference and need for consent. Eligible subjects' electronic health records will be mined for the baseline, midpoint, and final study metrics.

Other: Standard of Care (SOC)

Interventions

Tango Belt DEVICE

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.

Intervention Group

Standard of Care (SOC) OTHER

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.

Control Group; Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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

Sponsors & Collaborators

• ActiveProtective Technologies, Inc: lead
• Avania: collaborator

Study Sites (10)

Revere Court of Sacramento

Sacramento, California, 95831, United States

Location

Holy Redeemer Health System

Bensalem, Pennsylvania, 19020, United States

Location

Foulkeways at Gwynedd

Gwynedd, Pennsylvania, 19436, United States

Location

Country Meadows Hershey

Hershey, Pennsylvania, 17033, United States

Location

Meadowood Senior Living

Lansdale, Pennsylvania, 19446, United States

Location

Camilla Hall

Malvern, Pennsylvania, 19355, United States

Location

Chandler Hall Health Services

Newtown, Pennsylvania, 18940, United States

Location

The Heritage of Green Hills

Shillington, Pennsylvania, 19607, United States

Location

Country Meadows Wyomissing

Wyomissing, Pennsylvania, 19610, United States

Location

Country Meadows of York-South

York, Pennsylvania, 17403, United States

Location

Related Publications (17)

• CDC Facts About Falls. (2021, August 6). Centers for Disease Control and Prevention. https://www.cdc.gov/falls/facts.html

  BACKGROUND

• Bergen G, Stevens MR, Burns ER. Falls and Fall Injuries Among Adults Aged >/=65 Years - United States, 2014. MMWR Morb Mortal Wkly Rep. 2016 Sep 23;65(37):993-998. doi: 10.15585/mmwr.mm6537a2.

  PMID: 27656914 BACKGROUND

• Florence CS, Bergen G, Atherly A, Burns E, Stevens J, Drake C. Medical Costs of Fatal and Nonfatal Falls in Older Adults. J Am Geriatr Soc. 2018 Apr;66(4):693-698. doi: 10.1111/jgs.15304. Epub 2018 Mar 7.

  PMID: 29512120 BACKGROUND

• Panel on Prevention of Falls in Older Persons, American Geriatrics Society and British Geriatrics Society. Summary of the Updated American Geriatrics Society/British Geriatrics Society clinical practice guideline for prevention of falls in older persons. J Am Geriatr Soc. 2011 Jan;59(1):148-57. doi: 10.1111/j.1532-5415.2010.03234.x.

  PMID: 21226685 BACKGROUND

• CDC STEADI - Older Adult Fall Prevention, Resource Algorithm for Fall Risk Screening, Assessment, and Intervention. 2019. Centers for Disease Control and Prevention. www.cdc.gov/steadi.

  BACKGROUND

• Stefanacci RG, Haimowitz D. Stand by me--preventing falls. Geriatr Nurs. 2012 Mar-Apr;33(2):134-6. doi: 10.1016/j.gerinurse.2012.02.003. No abstract available.

  PMID: 22464055 BACKGROUND

• Kannus P, Parkkari J, Niemi S, Pasanen M, Palvanen M, Jarvinen M, Vuori I. Prevention of hip fracture in elderly people with use of a hip protector. N Engl J Med. 2000 Nov 23;343(21):1506-13. doi: 10.1056/NEJM200011233432101.

  PMID: 11087879 BACKGROUND

• Parker MJ, Gillespie WJ, Gillespie LD. Effectiveness of hip protectors for preventing hip fractures in elderly people: systematic review. BMJ. 2006 Mar 11;332(7541):571-4. doi: 10.1136/bmj.38753.375324.7C. Epub 2006 Mar 2.

  PMID: 16513687 BACKGROUND

• Bulat T, Powell-Cope G, Rubenstein L. Perceived Barriers and Facilitators for the Use of External Hip Protectors. Gerontological Journal. June 2004, Vol 3, No1.

  BACKGROUND

• Parkkari J, Heikkila J, Kannus IP. Acceptability and compliance with wearing energy-shunting hip protectors: a 6-month prospective follow-up in a Finnish nursing home. Age Ageing. 1998 Mar;27(2):225-9. doi: 10.1093/ageing/27.2.225.

  PMID: 16296684 BACKGROUND

• Moreland B, Kakara R, Henry A. Trends in Nonfatal Falls and Fall-Related Injuries Among Adults Aged >/=65 Years - United States, 2012-2018. MMWR Morb Mortal Wkly Rep. 2020 Jul 10;69(27):875-881. doi: 10.15585/mmwr.mm6927a5.

  PMID: 32644982 BACKGROUND

• Bhasin S, Gill TM, Reuben DB, Latham NK, Ganz DA, Greene EJ, Dziura J, Basaria S, Gurwitz JH, Dykes PC, McMahon S, Storer TW, Gazarian P, Miller ME, Travison TG, Esserman D, Carnie MB, Goehring L, Fagan M, Greenspan SL, Alexander N, Wiggins J, Ko F, Siu AL, Volpi E, Wu AW, Rich J, Waring SC, Wallace RB, Casteel C, Resnick NM, Magaziner J, Charpentier P, Lu C, Araujo K, Rajeevan H, Meng C, Allore H, Brawley BF, Eder R, McGloin JM, Skokos EA, Duncan PW, Baker D, Boult C, Correa-de-Araujo R, Peduzzi P; STRIDE Trial Investigators. A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries. N Engl J Med. 2020 Jul 9;383(2):129-140. doi: 10.1056/NEJMoa2002183.

  PMID: 32640131 BACKGROUND

• Gill TM, Bhasin S, Reuben DB, Latham NK, Araujo K, Ganz DA, Boult C, Wu AW, Magaziner J, Alexander N, Wallace RB, Miller ME, Travison TG, Greenspan SL, Gurwitz JH, Rich J, Volpi E, Waring SC, Manini TM, Min LC, Teresi J, Dykes PC, McMahon S, McGloin JM, Skokos EA, Charpentier P, Basaria S, Duncan PW, Storer TW, Gazarian P, Allore HG, Dziura J, Esserman D, Carnie MB, Hanson C, Ko F, Resnick NM, Wiggins J, Lu C, Meng C, Goehring L, Fagan M, Correa-de-Araujo R, Casteel C, Peduzzi P, Greene EJ. Effect of a Multifactorial Fall Injury Prevention Intervention on Patient Well-Being: The STRIDE Study. J Am Geriatr Soc. 2021 Jan;69(1):173-179. doi: 10.1111/jgs.16854. Epub 2020 Oct 9.

  PMID: 33037632 BACKGROUND

• Yang Y, Komisar V, Shishov N, Lo B, Korall AM, Feldman F, Robinovitch SN. The Effect of Fall Biomechanics on Risk for Hip Fracture in Older Adults: A Cohort Study of Video-Captured Falls in Long-Term Care. J Bone Miner Res. 2020 Oct;35(10):1914-1922. doi: 10.1002/jbmr.4048. Epub 2020 Jul 6.

  PMID: 32402136 BACKGROUND

• Quigley P, Singhatat W, Tarbert R. Technology Innovation to Protect Hips from Fall-Related Fracture. 2019, Phys Med Rehabil Res. Vol 4. 104. DOI: 10.15761/PMRR.1000205

  BACKGROUND

• Tarbert R, Singhatat W. Skilled Nursing Resident Adherence with Wearable Technology to Offer Safer Mobility and Decreased Fall Injuries. 2020. Journal of Pat Safety and Risk Man. DOI: 10.1177/2516043520979193

  BACKGROUND

• Stefanacci RG, Kinosian B. Mitigating Hip Injuries in High-Risk Older Adults: Clinical Evidence Supporting FDA Approval of a Novel Wearable Airbag Belt. J Am Med Dir Assoc. 2025 Nov;26(11):105851. doi: 10.1016/j.jamda.2025.105851. Epub 2025 Sep 10.

  PMID: 40887039 DERIVED

MeSH Terms

Conditions

Hip Injuries; Hip Fractures; Osteoporosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries; Femoral Fractures; Fractures, Bone; Leg Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr Rebecca J Tarbert
• Organization: ActiveProtective

Rebecca@activeprotective.com

267-242-6125

Study Officials

• Richard Stefanacci, DO, MGH,MBA, AGSF, CMD

  ActiveProtective Technologies, Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2022
• First Posted: February 17, 2022
• Study Start: March 29, 2022
• Primary Completion: November 3, 2023
• Study Completion: November 3, 2023
• Last Updated: June 13, 2025
• Results First Posted: June 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)