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Wearable Airbag Technology to Mitigate Falls in Individuals With High Fall Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05076565
Recruitment Status : Recruiting
First Posted : October 13, 2021
Last Update Posted : February 9, 2022
Sponsor:
Information provided by (Responsible Party):
Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab

Brief Summary:
The purpose of this study is to evaluate the feasibility and efficacy of a smart airbag system that detects and mitigates fall-related impact in individuals with high fall risk.

Condition or disease Intervention/treatment Phase
Stroke Parkinson Disease Lower Limb Amputation Knee Fall Injury Fall Patients Falling Device: Airbag Belt Fall Protection System Not Applicable

Detailed Description:

The purpose of this study is to evaluate the feasibility and efficacy of a smart airbag system that detects and mitigates fall-related impact in individuals with high fall risk.

The specific aims of this study are:

  1. To evaluate and optimize pre-fall detection algorithms and the usability of the smart airbag system for fall mitigation in individuals with high fall risk.
  2. To evaluate the efficacy of the smart airbag system in mitigating real-world falls and its effect on community mobility in individuals with high fall risk.

The investigators hypothesize that a soft, smart airbag system that uses advanced machine learning algorithms can accurately detect and mitigate falls, deploying appropriately to reduce hip fractures due to falls. The investigators also expect that wearing this device will decrease fear of falling and thus increase community mobility and social interaction.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This device feasibility enrollment number of 200 is a larger sample in order to create a machine learning algorithm
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Wearable Airbag Technology to Mitigate Falls in Individuals With High Fall Risk
Actual Study Start Date : January 14, 2018
Estimated Primary Completion Date : January 14, 2023
Estimated Study Completion Date : January 14, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls


Intervention Details:
  • Device: Airbag Belt Fall Protection System
    Both versions of Airbags features different number of IMU sensors. Participant's will be randomly assigned one of the two versions. The algorithms developed in this project will help the researcher to identify the optimal performance (sensitivity and specificity values for detecting falls). Based on this information the research team will be able to choose a version for home/community deployment portion of the study. Based on the performance of the airbags in detecting true positives (falls) and true negatives (non-falls) accurately one of the airbags will be used in community deployment phase of the study.


Primary Outcome Measures :
  1. Pre-fall classification performance [ Time Frame: 1 year ]
    Derivation(s) from a confusion matrix



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION AND EXCLUSION CRITERIA

All potential subjects will be evaluated by research staff in order to match them to the inclusion and exclusion criteria that has been established - see below:

Inclusion Criteria - Able bodied Subjects:

  • Healthy, able-bodied subject
  • Age constrained from 18-70 years old
  • No injury to either upper or lower extremity or history of back pain
  • English speaking.

Exlusion Criteria - Able bodied Subjects:

  • Waist circumference greater than 125 cm
  • Pregnant women (status determined by self-reporting)
  • Co-morbidity that interferes with the study (e.g. significant arthritis or joint problems, history of back injury, neuromuscular disorders, stroke, epilepsy, etc.)
  • Individuals currently on anti-coagulants.
  • Inactive, physically unfit
  • Severe Osteoporosis (status determined by self-reporting)
  • Non-English speaking
  • Cognitive deficits or visual impairments (MMSE score <17) that would impair their ability to give informed consent or impair their ability to follow simple instructions during the experiments

Inclusion Criteria - Fall Risk Subjects:

  • Ages between 18-85 years old
  • Individuals diagnosed with a Stroke (> 6 months post), Parkinson's disease, aging elderly (ages 60-85)or lower-limb amputee with at least one self-reported fall in the last six months.
  • Able to sit unsupported, walk at least with an assistive device and be able to follow a three-step command.
  • For individuals with Parkinson's disease, Scoring 1 or higher on questions in Section II (Activities of Daily Living) and Section III (Motor examinations) on the Unified PD Rating Scale (UPDRS), be able to walk at least with an assistive device and be able to follow a three-step command.
  • Waist circumference between 90 and 125 cm
  • Either homebound or community ambulators.
  • Willing to carry and use a smartphone and Airbag device.
  • Willing to wear the airbag system as directed by the research personnel.
  • English speaking
  • Able and willing to give written consent and comply with study procedures.

Exclusion Criteria - Fall Risk Subjects

  • Serious cardiac conditions, any musculoskeletal disorder, or other comorbidities that would interfere with participation in this minimal risk study.
  • Non-healing ulcers of a lower extremity, Renal dialysis or end-stage liver disease, Legal blindness or severe visual impairment, a history of significant psychiatric illness.
  • Subjects reporting a head injury from exposure to a blast/concussion injury with one or more of the following symptoms: dizziness, vertigo, headache, migraine, oscillopsia, movement induced vertigo, imbalance.
  • Individuals who use a wheelchair for mobility both outdoors and indoors.
  • Waist circumference greater than 125 cm
  • Non-English speaking individuals
  • Severe Osteoporosis (status determined by self-reporting,medical records)
  • The subject is pregnant, nursing or planning a pregnancy.
  • Individuals currently on anti-coagulants.
  • Cognitive deficits or visual impairments (MMSE score < 17) that would impair their ability to give informed consent or impair their ability to follow simple instructions during the experiments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05076565


Contacts
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Contact: Olivia Botonis, BS 312-238-1114 obotonis@sralab.org
Contact: Kyle Embry, PhD 312-238-7327 kembry@sralab.org

Locations
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United States, Illinois
Shirley Ryan AbilityLab Recruiting
Chicago, Illinois, United States, 60611
Contact: Olivia Botonis, BS    312-238-1114    obotonis@sralab.org   
Sponsors and Collaborators
Shirley Ryan AbilityLab
Investigators
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Principal Investigator: Arun Jayaraman, PT, PhD Shirley Ryan AbilityLab
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Arun Jayaraman, PT, PhD, Principal Investigator, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier: NCT05076565    
Other Study ID Numbers: STU00209246
First Posted: October 13, 2021    Key Record Dates
Last Update Posted: February 9, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases