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Toward use of the synergy-based SoftHand Pro for activities of daily living by transradial amputees: A multi-site clinical trial

Award Number: R01HD102615
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/12/2021
PERIOD OF PERFORMANCE END DATE: 07/31/2026

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Toward use of the synergy-based SoftHand Pro for activities of daily living by transradial amputees: A multi-site clinical trial - PROJECT SUMMARY The human hand plays a critical role in performing many daily activities including self-feeding, tool use, and recreation. Therefore, loss of the hand due to traumatic injury or disease can significantly limit or interfere with the ability of persons with limb loss to perform daily activities and work, thus greatly affecting overall quality of life. Despite advances in prosthetic hand design and research, several barriers to widespread acceptance of prosthetic hands by persons with upper limb loss remain, including limited ability to perform daily activities and poor durability of the prosthetic hand. Therefore, today’s commercially-available myoelectric hand prostheses fail to address the needs of persons with limb loss, i.e., regaining some degree of autonomy, functionality, and re-entry into the work force. To address these gaps, in the past few years we have investigated the extent to which an artificial anthropomorphic hand originally designed for robotic grasping and manipulation – the SoftHand – could be used for prosthetic applications through a non-invasive myoelectric controller – the SoftHand Pro (SHP). The novel design of the SHP is the only prosthetic hand in the world that combines the concept of human hand synergies and soft robotics technologies. The results of preliminary functional assessments and biomechanical analyses revealed that individuals with upper limb loss could perform a variety of grasping and manipulation tasks with the SHP at levels similar or superior to those of their preferred prosthetic device. Additionally, subject surveys reported positive feedback about the ease and comfort associated with using the SHP. This feedback was also instrumental in making software and hardware improvements to make the hand lighter and able to grasp and manipulate small objects. We propose to determine the extent to which the SHP can address three critical needs of transradial amputees that are not met by commercially-available hand prostheses: function, versatility, and robustness. We will attain this objective by comparing its function, versatility, and robustness with a commercially-available multi-digit prosthetic hand, the i-limb (Ossur). We will pursue three aims: (1) to determine the extent to which performance of grasping and manipulation tasks using the SHP is superior to the i-limb, (2) to determine the extent to which daily use of the SHP and i-limb over an extended period of time improves grasping and manipulation performance, and (3) to obtain SHP usage patterns and subjects’ satisfaction ratings from using the SHP and i-limb. We will test the hypotheses that (1) the SHP will outperform the i-limb, and (2) daily use of both prosthetic hands over an 8-week period each will lead to significantly greater improvement in grasping and manipulation performance with the SHP than the i-limb. We will obtain usage and survey data collected through the SHP and i-limb firmware during daily use to complement data obtained in Aims 1 and 2 to explore daily use. This proposed work is significant because it will shed insight on whether an innovative soft synergy- based prosthetic design allows for function, versatility and robustness not available in commercial prostheses.


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: 2025 ( Subtotal = $614,154 )
2025	2025	ARIZONA STATE UNIVERSITY	660 S MILL AVENUE STE 204	TEMPE	AZ	85281	MARICOPA	USA	Child Health and Human Development Extramural Research	000	5	7/23/2025	NON-COMPETING CONTINUATION	$614,154
														Subtotal = $614,154

Issue Date FY: 2024 ( Subtotal = $608,013 )
2024	2024	ARIZONA STATE UNIVERSITY	660 S MILL AVENUE STE 204	TEMPE	AZ	85281	MARICOPA	USA	Child Health and Human Development Extramural Research	000	4	7/2/2024	NON-COMPETING CONTINUATION	$608,013
														Subtotal = $608,013

Issue Date FY: 2023 ( Subtotal = $620,230 )
2023	2023	ARIZONA STATE UNIVERSITY	660 S MILL AVENUE STE 204	TEMPE	AZ	85281	MARICOPA	USA	Child Health and Human Development Extramural Research	000	3	7/28/2023	NON-COMPETING CONTINUATION	$620,230
														Subtotal = $620,230

Issue Date FY: 2022 ( Subtotal = $618,832 )
2022	2022	ARIZONA STATE UNIVERSITY	660 S MILL AVE STE 312	TEMPE	AZ	85281	MARICOPA	USA	Child Health and Human Development Extramural Research	001	2	8/16/2022	NON-COMPETING CONTINUATION	$618,832
2022	2022	ARIZONA STATE UNIVERSITY	660 S MILL AVE STE 312	TEMPE	AZ	85281	MARICOPA	USA	Child Health and Human Development Extramural Research	002	2	9/6/2022	NON-COMPETING CONTINUATION	$0
2022	2021	ARIZONA STATE UNIVERSITY	660 S MILL AVE STE 312	TEMPE	AZ	85281	MARICOPA	USA	Child Health and Human Development Extramural Research	000	1	12/16/2021	NEW	$0
														Subtotal = $618,832

Issue Date FY: 2021 ( Subtotal = $637,821 )
2021	2021	ARIZONA STATE UNIVERSITY	660 S MILL AVE STE 312	TEMPE	AZ	85281	MARICOPA	USA	Child Health and Human Development Extramural Research	000	1	8/12/2021	NEW	$637,821
														Subtotal = $637,821

Grand Total All Awards = $3,099,050

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Toward use of the synergy-based SoftHand Pro for activities of daily living by transradial amputees: A multi-site clinical trial

Award Number: R01HD102615

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/12/2021

PERIOD OF PERFORMANCE END DATE: 07/31/2026

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