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

Primary Purpose

Stroke, Parkinson Disease, Lower Limb Amputation Knee

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Airbag Belt Fall Protection System
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Shirley Ryan AbilityLabRecruiting

Outcomes

Primary Outcome Measures

Pre-fall classification performance
Derivation(s) from a confusion matrix

Secondary Outcome Measures

Full Information

First Posted
June 11, 2021
Last Updated
February 17, 2023
Sponsor
Shirley Ryan AbilityLab
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1. Study Identification

Unique Protocol Identification Number
NCT05076565
Brief Title
Wearable Airbag Technology to Mitigate Falls in Individuals With High Fall Risk
Official Title
Wearable Airbag Technology to Mitigate Falls in Individuals With High Fall Risk
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 14, 2018 (Actual)
Primary Completion Date
December 14, 2023 (Anticipated)
Study Completion Date
December 14, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Parkinson Disease, Lower Limb Amputation Knee, Fall Injury, Fall Patients, Falling

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Airbag Belt Fall Protection System
Intervention Description
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 Measure Information:
Title
Pre-fall classification performance
Description
Derivation(s) from a confusion matrix
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivia Botonis, BS
Phone
312-238-1114
Email
obotonis@sralab.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kyle Embry, PhD
Phone
312-238-7327
Email
kembry@sralab.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arun Jayaraman, PT, PhD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivia Botonis, BS
Phone
312-238-1114
Email
obotonis@sralab.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35715823
Citation
Botonis OK, Harari Y, Embry KR, Mummidisetty CK, Riopelle D, Giffhorn M, Albert MV, Heike V, Jayaraman A. Wearable airbag technology and machine learned models to mitigate falls after stroke. J Neuroeng Rehabil. 2022 Jun 17;19(1):60. doi: 10.1186/s12984-022-01040-4.
Results Reference
derived

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

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