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CompletedNCT05245097Updated Jun 13, 2025Results posted

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

An interventional study of Tango Belt and Standard of Care (SOC) in Hip Injuries, Fractures, Hip and Fall Injury, sponsored by ActiveProtective Technologies, Inc. Completed at 10 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-06-13.

Sponsored by ActiveProtective Technologies, Inc · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
471
Allocation
Non-randomized
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Fall risk
  • Fall injury
  • Major hip injury
  • Hip fracture
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 471 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

This is the only study on the registry with ActiveProtective Technologies, Inc as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
471 participants (actual)

Study arms

  • 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 · Other: Standard of Care (SOC)

  • Other
    Control Group

    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

  • DeviceTango 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.

  • OtherStandard 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.

06

What researchers measure

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.

    Time frame: 6 months

Secondary outcomes

  1. Number of Hip Fractures Related to Fall

    The number of subjects in the ITT group with hip fractures related to a fall event.

    Time frame: 6 months

  2. Number of Emergency Department Visits Related to Fall

    The number of subjects in the ITT group with emergency department visits related to fall.

    Time frame: 6 months

  3. Number of Hospitalizations Due to Fall

    The number of subjects in the ITT group admitted to a hospital due to fall.

    Time frame: 6 months

Other outcomes

  1. Number and Severity of Adverse Events

    An Adverse Event is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. A Severe Adverse Event is any AE that results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/ incapacity.

    Time frame: 6 months

  2. Number of Major Injuries Due to Fall

    The number of major injuries that were due to a fall.

    Time frame: 6 months

  3. Rate of Fall Occurence

    The fall rate for the intervention and the control group

    Time frame: 6 months

  4. Device Wear Adherence

    Adherence to wearing of the study device in days/month

    Time frame: 90 days and 180 days

  5. Device Wear Compliance

    Compliance to wearing of the study device in hours/day average

    Time frame: 6 months

  6. Accuracy of Device Fall Discrimination

    Rate of airbag deployments that occurred while an intervention subject was not experiencing a serious hip-impacting fall.

    Time frame: 6 months

  7. Accuracy of Study Device Airbag Deployment

    Accuracy of the study device airbag deployment as designed is demonstrated in the number of hip fractures that occurred by intervention subjects wearing the device during serious hip-impacting falls.

    Time frame: 6 months

  8. Balance Confidence Score Changes

    Short version of the Falls Efficacy Scale International (where applicable for those deemed able to take the questionnaire (BIMS of 13-15)) to offer level of balance confidence as defined by the scale (range from 7 (no concern about falling) to 28 (severe concern about falling).

    Time frame: 6 months

07

Results

Posted Jun 13, 2025

Participant flow

The intervention group was recruited via clinical site health record review for the inclusion/exclusion criteria available and waist circumference obtained by sub-investigator on-site and offered informed consent. The control group was determined via historical clinical site health record review determining subject eligibility based on inclusion/exclusion criteria except waist circumference and did not need consent.

Participant flow — Overall Study
MilestoneIntervention GroupControl Group
Started134264
Completed79246
Not completed5518
Withdrew: Adverse event132
Withdrew: Protocol violation86
Withdrew: Withdrawal by subject180
Withdrew: Death67
Withdrew: Physician decision60
Withdrew: Relocation43

Outcome measures

PrimaryMajor 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.

Time frame:
6 months
Reported as:
Number · percentage of participants
Major Hip Injuries Due to Serious Hip-impacting Fall
percentage of participantsIntervention GroupControl Group
Major Hip Injuries Due to Serious Hip-impacting Fall1.1 (0.00 to 3.39)12.1 (8.44 to 16.68)
Statistical analysis
  • Intervention Group vs Control Group · Regression, Logistic · p = 0.004 (The null hypothesis was tested at a one-sided 0.025 level of significance using a logistic regression analysis to compare treatment groups while controlling for propensity score.)
SecondaryNumber of Hip Fractures Related to Fall

The number of subjects in the ITT group with hip fractures related to a fall event.

Time frame:
6 months
Reported as:
Number · participants
Number of Hip Fractures Related to Fall
participantsIntervention GroupControl Group
Number of Hip Fractures Related to Fall3 (1 to 9)30 (21 to 42)
Statistical analysis
  • Intervention Group vs Control Group · Regression, Logistic · p = 0.003 (The hip fracture due to fall rate was compared between treatment groups using firth logistic regression while controlling for propensity score. A one-sided 0.025 level of significance was used.)
  • Intervention Group vs Control Group · Regression, Logistic · p = 0.003
SecondaryNumber of Emergency Department Visits Related to Fall

The number of subjects in the ITT group with emergency department visits related to fall.

Time frame:
6 months
Reported as:
Number · participants
Number of Emergency Department Visits Related to Fall
participantsIntervention GroupControl Group
Number of Emergency Department Visits Related to Fall8 (3 to 15)47 (36 to 60)
Statistical analysis
  • Intervention Group vs Control Group · Regression, Logistic · p = 0.001 (The emergency department visit due to fall rate was compared between treatment groups using firth logistic regression while controlling for propensity score. A one-sided 0.025 level of significance was used.)Subjects with multiple ED visits due to falls are only counted once.
SecondaryNumber of Hospitalizations Due to Fall

The number of subjects in the ITT group admitted to a hospital due to fall.

Time frame:
6 months
Reported as:
Number · participants
Number of Hospitalizations Due to Fall
participantsIntervention GroupControl Group
Number of Hospitalizations Due to Fall11 (6 to 19)50 (38 to 64)
Statistical analysis
  • Intervention Group vs Control Group · Regression, Logistic · p = 0.003 (The hospitalization due to fall rate was compared between treatment groups using firth logistic regression while controlling for propensity score. A one-sided 0.025 level of significance was used.)Subjects with multiple hospitalizations due to falls are only counted once.
Other pre-specifiedNumber and Severity of Adverse Events

An Adverse Event is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. A Severe Adverse Event is any AE that results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/ incapacity.

Time frame:
6 months
Reported as:
Number · Number of events
Number and Severity of Adverse Events
Number of eventsSafety PopulationControl Group
Mild Severity Adverse event163232
Moderate Severity Adverse Event2970
Severe Severity Adverse Event2766
Other pre-specifiedNumber of Major Injuries Due to Fall

The number of major injuries that were due to a fall.

Time frame:
6 months
Reported as:
Number · Major injuries due to fall
Number of Major Injuries Due to Fall
Major injuries due to fallIntervention GroupControl Group
Number of Major Injuries Due to Fall767
Other pre-specifiedRate of Fall Occurence

The fall rate for the intervention and the control group

Time frame:
6 months
Reported as:
Number · Falls per 180-day duration
Rate of Fall Occurence
Falls per 180-day durationIntervention GroupControl Group
Rate of Fall Occurence1.561.31
Other pre-specifiedDevice Wear Adherence

Adherence to wearing of the study device in days/month

Time frame:
90 days and 180 days
Reported as:
Mean · Tango Belt wear in Days/month
Device Wear Adherence
Tango Belt wear in Days/monthIntervention Group
90 day21.9 ± 6.08
180 day20.1 ± 6.71
Other pre-specifiedDevice Wear Compliance

Compliance to wearing of the study device in hours/day average

Time frame:
6 months
Reported as:
Number · hours/day in-study time
Device Wear Compliance
hours/day in-study timeIntervention Group
Device Wear Compliance5.9
Other pre-specifiedAccuracy of Device Fall Discrimination

Rate of airbag deployments that occurred while an intervention subject was not experiencing a serious hip-impacting fall.

Time frame:
6 months
Reported as:
Number · false positives per 1000 person-days
Accuracy of Device Fall Discrimination
false positives per 1000 person-daysSafety Population
Accuracy of Device Fall Discrimination1.59
Other pre-specifiedAccuracy of Study Device Airbag Deployment

Accuracy of the study device airbag deployment as designed is demonstrated in the number of hip fractures that occurred by intervention subjects wearing the device during serious hip-impacting falls.

Time frame:
6 months
Reported as:
Count of participants · Participants
Accuracy of Study Device Airbag Deployment
ParticipantsThe Adherence Population
Accuracy of Study Device Airbag Deployment0
Other pre-specifiedBalance Confidence Score Changes

Short version of the Falls Efficacy Scale International (where applicable for those deemed able to take the questionnaire (BIMS of 13-15)) to offer level of balance confidence as defined by the scale (range from 7 (no concern about falling) to 28 (severe concern about falling).

Time frame:
6 months
Reported as:
Mean · FES-I Short Version Score
Balance Confidence Score Changes
FES-I Short Version ScoreIntervention Group
Baseline15.3 ± 4.29
90 day15.4 ± 4.16
180 day14.7 ± 4.68

Adverse events

Collected over Adverse events were recorded for all study subjects within their respective 6 month in-study timeframe.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Safety Population6/207 (2.9%)33/207 (15.9%)67/207 (32.4%)
Control Group7/264 (2.7%)66/264 (25%)152/264 (57.6%)
Most frequent serious events
Most frequent serious events
EventSafety PopulationControl Group
Fall with FractureMusculoskeletal and connective tissue disorders6/20757/264
OtherGeneral disorders23/2077/264
InfectionInfections and infestations4/2071/264
DislocationMusculoskeletal and connective tissue disorders0/2071/264
Most frequent other events
Most frequent other events
EventSafety PopulationControl Group
Fall EventMusculoskeletal and connective tissue disorders44/207119/264
DiscomfortSkin and subcutaneous tissue disorders25/20740/264
LacerationSkin and subcutaneous tissue disorders14/20732/264
OtherGeneral disorders24/20725/264
abrassionSkin and subcutaneous tissue disorders9/20725/264
confusionPsychiatric disorders6/20714/264
SorenessMusculoskeletal and connective tissue disorders4/20713/264

Baseline characteristics

Age, Continuous
Age, Continuous(years)Intervention GroupControl GroupTotal
Mean87.3 ± 7.1587.5 ± 6.4087.5 ± 6.7
Sex: Female, Male
Sex: Female, Male(Participants)Intervention GroupControl GroupTotal
Female102209311
Male325587
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Intervention GroupControl GroupTotal
Race — American Indian or Alaskan Native000
Race — Asian145
Race — Black or African American112
Race — Native Hawaiian or Other Pacific Islander000
Race — White129257386
Race — Other325
Region of Enrollment
Region of Enrollment(participants)Intervention GroupControl GroupTotal
United States134264398
Highest Mobility Level
Highest Mobility Level(Participants)Intervention GroupControl GroupTotal
Independent75149224
Supervision244468
Limited Assist3470104
Extensive Assist112
Total Dependence000
Fall Risk Factor
Fall Risk Factor(Participants)Intervention GroupControl GroupTotal
Count of participants125249374
08

Study locations

10 sites
  • Revere Court of Sacramento
    Sacramento, California 95831, United States
  • Holy Redeemer Health System
    Bensalem, Pennsylvania 19020, United States
  • Foulkeways at Gwynedd
    Gwynedd, Pennsylvania 19436, United States
  • Country Meadows Hershey
    Hershey, Pennsylvania 17033, United States
  • Meadowood Senior Living
    Lansdale, Pennsylvania 19446, United States
  • Camilla Hall
    Malvern, Pennsylvania 19355, United States
  • Chandler Hall Health Services
    Newtown, Pennsylvania 18940, United States
  • The Heritage of Green Hills
    Shillington, Pennsylvania 19607, United States
  • Country Meadows Wyomissing
    Wyomissing, Pennsylvania 19610, United States
  • Country Meadows of York-South
    York, Pennsylvania 17403, United States
09

References and documents

Publications

  • 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. PubMed 27656914 ↗
  • 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. PubMed 29512120 ↗
  • 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. PubMed 21226685 ↗
  • 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. PubMed 22464055 ↗
  • 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. PubMed 11087879 ↗
  • 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. PubMed 16513687 ↗
  • 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. PubMed 16296684 ↗
  • 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. PubMed 32644982 ↗
  • 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. PubMed 32640131 ↗
  • 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. PubMed 33037632 ↗
  • 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. PubMed 32402136 ↗
  • 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 documents

  • Protocol, analysis plan and consent form · Dec 7, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05245097
Lead sponsor
ActiveProtective Technologies, Inc
Collaborators
Avania
Responsible party
Sponsor
First posted
Feb 17, 2022
Start date
Mar 29, 2022
Primary completion
Nov 3, 2023
Completion
Nov 3, 2023
Results posted
Jun 13, 2025
Last update
Jun 13, 2025

Study contacts

Richard Stefanacci, DO, MGH,MBA, AGSF, CMD
principal investigator · ActiveProtective Technologies, Inc

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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