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

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.

Study Overview

• Status: Completed
• Conditions: Hip Injuries; Osteoporosis; Osteoporosis Risk; Fall Injury; Fractures, Hip; Fall Risk
• Intervention / Treatment: Device: Tango Belt

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. Effectiveness of the Tango Belt will be determined by analysis of evidence for the Tango Belt as an adjunctive intervention to the standard-of-care (SOC) to mitigate major hip injuries from falls in an older adult population at-risk for fall injury as the primary endpoint. Performance of the Tango Belt to mitigate fall injuries that result in hip fracture, emergency room visits, and hospitalizations will be secondary endpoints. The performance of the device is determined by the comparison of the proportion of fall-related major hip injuries in the intervention group as compared to the proportion of fall-related major hip injuries in a retrospective control group utilizing only SOC. SOC utilization will be verified for each clinical site enrolled. An adaptive trial design will be utilized to allow an initial efficacy target to be evaluated at 6 months; if the initial target is not met, then a second cohort of sites and subjects will be enrolled for an additional 6 months to allow a lower efficacy target to be evaluated.

Safety of the device will be determined by analysis of adverse events as an ancillary endpoint.

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: REBECCA J TARBERT, PT, DPT; Phone Number: 267-242-6125; Email: rebecca@activeprotective.com

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95831
      • Revere Court of Sacramento
  • Pennsylvania
    • Bensalem, Pennsylvania, United States, 19020
      • Holy Redeemer Health System
    • Gwynedd, Pennsylvania, United States, 19436
      • Foulkeways at Gwynedd
    • Hershey, Pennsylvania, United States, 17033
      • Country Meadows Hershey
    • Lansdale, Pennsylvania, United States, 19446
      • Meadowood Senior Living
    • Malvern, Pennsylvania, United States, 19355
      • Camilla Hall
    • Newtown, Pennsylvania, United States, 18940
      • Chandler Hall Health Services
    • Shillington, Pennsylvania, United States, 19607
      • The Heritage of Green Hills
    • Wyomissing, Pennsylvania, United States, 19610
      • Country Meadows Wyomissing
    • York, Pennsylvania, United States, 17403
      • Country Meadows of York-South

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 65 years or older;
2. 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.
3. 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);
4. Have a waist circumference between 29 - 50 inches (63.5 - 127 cm);
5. Able to comply with required study procedures and follow-up schedule as determined by the Study Investigator;
6. Are under the care of the Investigational organization;
7. Provides consent or their legally authorized representative provides consent on subject's behalf

Exclusion Criteria:

1. Age 64 years or less;
2. Participation in a different clinical investigation that can conflict with this clinical study as determined by the Study Investigator and approved by the Sponsor;
3. 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;
4. Use of other devices or interventions outside of SOC (Standard of care) for fall risk management during study participation without Sponsor approval;
5. Unable to comply with required study procedures and follow-up schedule as determined by the Study Investigator;
6. Does not provide consent, or legally authorized representative does not provide consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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; 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.
No Intervention: Control Group; The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major hip injuries due to fall	The proportion of major hip injuries due to fall in the subjects receiving SOC as compared to subjects receiving SOC plus the Tango Belt.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of hip fractures due to fall	The number of hip fractures due to fall in the subjects receiving SOC as compared to subjects receiving SOC plus the Tango Belt.	6 months
Number of emergency department visits due to fall	The number of emergency department visits due to fall in the subjects receiving SOC as compared to subjects receiving SOC plus the Tango Belt.	6 months
Number of hospitalizations due to fall	The number of admissions to a hospital due to fall in the subjects receiving SOC as compared to subjects receiving SOC plus the Tango Belt.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and severity of Adverse Events		6 months
Number of major injuries due to fall		6 months
Rate of fall occurence		6 months
Device wear adherence	Adherence to wearing of the study device in days/month	6 months
Device wear compliance	Compliance to wearing of the study device in hours/day average	6 months
Accuracy of device fall discrimination	Device discrimination of serious hip-impacting vs. non-serious hip and non-hip impacting falls	6 months
Accuracy of study device airbag deployment		6 months
Balance confidence score changes	Short version of the Falls Efficacy Scale International (where applicable) to offer level of balance confidence as defined by the scale (range from 7 (no concern about falling) to 28 (severe concern about falling).	6 months

Collaborators and Investigators

• Sponsor: ActiveProtective Technologies, Inc
• Collaborators: Avania
• Investigators: Principal Investigator: Richard Stefanacci, DO, MGH,MBA, AGSF, CMD, ActiveProtective Technologies, Inc

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2022
• Primary Completion (Actual): November 3, 2023
• Study Completion (Actual): November 3, 2023

Study Registration Dates

• First Submitted: January 29, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Hip fracture; Fall risk; Fall injury; Major hip injury
• Additional Relevant MeSH Terms: Metabolic Diseases; Fractures, Bone; Leg Injuries; Musculoskeletal Diseases; Bone Diseases; Femoral Fractures; Bone Diseases, Metabolic; Wounds and Injuries; Hip Fractures; Osteoporosis; Hip Injuries
• Other Study ID Numbers: COP-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes