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Development of a robotic ankle assist device to improve mobility in individuals with movement disorders.

Award Number: R44HD104328
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: 09/01/2021
PERIOD OF PERFORMANCE END DATE: 08/31/2024

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Development of a robotic ankle assist device to improve mobility in individuals with movement disorders. - PROJECT SUMMARY/ABSTRACT A child’s ability to engage in physical activity is essential to their health, independence, and general well-being. Many of the 500k children in the United States with cerebral palsy (CP), the most common cause of pediatric physical disability, have difficulty walking and participating in physical activity. This reduced physical activity in CP is a primary contributor to the greater incidence of metabolic dysfunction, cardiovascular disease, osteoporosis, pain, and diminished psycho-social quality of life. Unfortunately, half of all ambulatory children with CP lose the ability to walk independently in adulthood, indicating that the current approaches for treating these individuals do not result in meaningfully improved mobility over time. Physical Therapy (PT) is essential for treating CP but the amount of PT is generally insufficient, and the delivery of PT can be inefficient. There is currently no viable way to provide a sufficient dose of PT that will lead to long-term improvements in mobility and reduce the negative physical and social outcomes noted above. BiOMOTUM’s (applicant) goal is to create a reimbursable wearable system for children with CP that will (1) make walking easier and improve free-living mobility, (2) increase the dose and precision of ankle plantar-flexor therapy to produce lasting improvements in neuromuscular function, and (3) create a virtual community to incentivize the use of the system and track improvement. To achieve these goals, this project uses a lightweight, low-profile, battery-powered, wearable Robotic Ankle Assistive Device (RAAD). The overall objectives of this proposal are to establish feasibility of the RAAD system to improve mobility in free-living settings and to establish the RAAD as an effective tool to provide increased dose and precision of targeted ankle therapy. The first specific aim is to complete a personal-use feasibility analysis of ankle mobility assistance. It is hypothesized the children will be able to safely walk faster and travel farther in the community when using the RAAD device vs. without the device. The second specific aim is to gather feedback to design and prototype a minimum viable product for use in clinical and community settings. The third specific aim is to quantify the potential for the RAAD system to increase the effectiveness of clinical gait therapy. Individuals with CP will complete three training sessions: RAAD assistance, RAAD resistance and standard of care. Muscle activity and step activity will be measured during each session. It is hypothesized that the RAAD assistance and resistance therapy will improve ankle plantar-flexor muscle activity and treatment session quality compared to traditional physical therapist-guided gait training. The fourth specific aim is to assess the benefits of repeated gait training with RAAD assistance and resistance. Individuals with CP will participate in a 4-week assistance or resistance intervention and mobility outcomes will be quantified pre and post intervention. It is hypothesized that both assistance and resistance training will improve mobility outcomes. This proposal paves the way for commercializing the device and implementing future longitudinal interventions that will investigate the potential for RAAD to improve quality of life and long-term clinical outcomes.


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 = -$36,972 )
2025	2022	BIOMOTUM, INC	3025 SW 1ST AVE	PORTLAND	OR	97201	MULTNOMAH	USA	Child Health and Human Development Extramural Research	000	3	1/16/2025	NON-COMPETING CONTINUATION	-$36,972
														Subtotal = -$36,972

Issue Date FY: 2022 ( Subtotal = $772,373 )
2022	2022	BIOMOTUM, INC.	625 N PINE CLIFF DR	FLAGSTAFF	AZ	86001	COCONINO	USA	Child Health and Human Development Extramural Research	002	3	8/20/2022	NON-COMPETING CONTINUATION	$772,373
2022	2021	BIOMOTUM, INC.	625 N PINE CLIFF DR	FLAGSTAFF	AZ	86001	COCONINO	USA	Child Health and Human Development Extramural Research	001	2	1/4/2022	EXTENSION WITH OR WITHOUT FUNDS	$0
2022	2020	BIOMOTUM, INC.	625 N PINE CLIFF DR	FLAGSTAFF	AZ	86001	COCONINO	USA	Child Health and Human Development Extramural Research	000	1	12/29/2021	NEW	$0
														Subtotal = $772,373

Issue Date FY: 2021 ( Subtotal = $884,564 )
2021	2021	BIOMOTUM, INC.	625 N PINE CLIFF DR	FLAGSTAFF	AZ	86001	COCONINO	USA	Child Health and Human Development Extramural Research	001	2	8/19/2021	EXTENSION WITH OR WITHOUT FUNDS	$884,564
2021	2020	BIOMOTUM, INC.	625 N PINE CLIFF DR	FLAGSTAFF	AZ	86001	COCONINO	USA	Child Health and Human Development Extramural Research	000	1	10/14/2020	NEW	$0
														Subtotal = $884,564

Issue Date FY: 2020 ( Subtotal = $298,438 )
2020	2020	BIOMOTUM, LLC	625 N PINE CLIFF DR	FLAGSTAFF	AZ	86001	COCONINO	USA	Child Health and Human Development Extramural Research	000	1	9/21/2020	NEW	$298,438
														Subtotal = $298,438

Grand Total All Awards = $1,918,403

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Development of a robotic ankle assist device to improve mobility in individuals with movement disorders.

Award Number: R44HD104328

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: 09/01/2021

PERIOD OF PERFORMANCE END DATE: 08/31/2024

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