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Ethical Considerations in The Design and Testing of Back-Support Exoskeletons

Award Number: R21EB036439
ORGANIZATION: NATIONAL INSTITUTE Of BIOMEDICAL IMAGING & BIOENGINEERING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/05/2024
PERIOD OF PERFORMANCE END DATE: 09/04/2026

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Ethical Considerations in The Design and Testing of Back-Support Exoskeletons - Project Summary Low-back pain is the primary cause of disability across the world, and over 80% of workplace injuries also occur to the lower back. Wearable robotic technologies, such as back-support exoskeletons (BSE), provide on-body assistance to support and assist the trunk. BSEs are rapidly emerging as a potential intervention to reduce the risk of occupational musculoskeletal disorders. However, user expectations for intimate body-worn devices such as exoskeletons are likely to vary significantly across diverse user-groups representing different sex, age, and racial characteristics. Current design/testing approaches that do not include diverse user perspectives in these early stages of design and development of health interventions such as wearable robotics technologies can lead to ethical challenges in equitable accessibility and technology acceptance. The ethical question addressed in this proposal is whether user perceptions, technology acceptance, and health effects of exoskeletons significantly differ across race, as this is currently undocumented in the literature. Our hypothesis is that important race related differences among men and women in physical characteristics like anthropometry and strength, and psychosocial factors influencing technology adoption, are likely to produce differences in user-acceptance and health benefits of BSEs. We postulate that limited participant selection/representation in current exoskeleton study designs is thus a critical ethical concern that may lead to health disparities if unaddressed. A repeated-measures mixed-methods study, with a total of 80 participants representing men and women of different racial groups, is proposed. Participants will trial two different BSEs and complete a standardized battery of tasks. Our first specific aim is to document and analyze user-preferences and health effects of BSEs for different racial groups. We will characterize race-related differences in physical design preferences, device usability, opinions about BSE usefulness, and physical, psychological, and socio-cultural factors promoting/inhibiting BSE use. We will also quantify racial differences in health effects of BSEs using biomechanical measures of device effectiveness in trunk (primary) and hip/knee (secondary) body regions. Our second specific aim is to explore race-related differences in factors that predict user acceptance of BSEs, using a decision tree analysis to predict exoskeleton acceptance for each racial group. Outcomes from this study will help document the ethical concerns in current exoskeleton design and evaluation methods. Detailed data on anthropometric fit and user-preferences, evidence of their correlations with the subjective and objective assessments of exoskeleton effectiveness, and feedback from our diverse stakeholder group (advisory board) will be broadly disseminated, to guide future inclusive design and use of exoskeletons.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2024	CLEMSON UNIVERSITY	201 SIKES HALL	CLEMSON	SC	29634	PICKENS	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	1	4/7/2026	NEW	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $377,809 )
2024	2024	CLEMSON UNIVERSITY	201 SIKES HALL	CLEMSON	SC	29634	PICKENS	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	1	9/5/2024	NEW	$377,809
														Subtotal = $377,809

Grand Total All Awards = $377,809

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Ethical Considerations in The Design and Testing of Back-Support Exoskeletons

Award Number: R21EB036439

ORGANIZATION: NATIONAL INSTITUTE Of BIOMEDICAL IMAGING & BIOENGINEERING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/05/2024

PERIOD OF PERFORMANCE END DATE: 09/04/2026

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