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Orthotics and Prosthetics Outcomes

NEWS RELEASE

Released: February 8, 2023

Department of Defense
Congressionally Directed Medical Research Programs (CDMRP)
Orthotics and Prosthetics Outcomes Research Program
Anticipated Funding Opportunities for Fiscal Year 2023 (FY23)

The FY23 Defense Appropriations Act provides funding for the Orthotics and Prosthetics Outcomes Research Program (OPORP) to support research that evaluates orthoses and/or prostheses using patient-centric outcomes relevant to the Service Member and military beneficiaries, Veterans, and other individuals with limb loss and/or limb impairment. The managing agent for the anticipated funding opportunities is the CDMRP at the U.S. Army Medical Research and Development Command (USAMRDC).

The OPORP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY23 funding opportunities. This pre-announcement should not be construed as an obligation by the government. The FY23 OPORP funding opportunity announcements for the following award mechanisms will be posted on the Grants.gov website. Pre-application and application deadlines will be available when the announcements are released.

In order to attain the highest possible quality of life for individuals with limb loss and limb impairment, the OPORP supports research on outcomes-based best practices through analysis of prosthetic and/or orthotic device options that are currently available, and not on the development of new devices or the improvement of an existing technology. Development and employment of new approaches and tools for measuring outcomes is allowed and encouraged. New for FY23, the OPORP is interested in expanding the impact of the research within the OPORP portfolio by funding orthotic- and prosthetic-outcomes research to include, but not limited to, topics in injury and trauma, stroke, neuropathy, diabetes, vascular disease, and/or infection. Projects involving spinal orthoses, pediatric populations, or exclusively addressing therapeutic insoles will not be considered for the FY23 OPORP.

Applications submitted to the FY23 OPORP must address one or more of the following Strategic Goals: 

  • Optimize patient-specific technology prescription. Applications submitted to this goal should focus on identifying optimal (1) devices and device characteristics, (2) human interface with devices, and/or (3) intuitive control systems, all grounded in an understanding of the requirements of patient-specific needs and the capabilities and limitation of available devices. 
  • Optimize patient-specific rehabilitation regimens. Applications submitted to this goal should address the cause and effect of an orthotic or prosthetic device on optimal type, timing, and dosing (e.g. duration, frequency, intensity) of rehabilitation for each individual in the context of each person’s unique requirements and preferences. Efforts that also address the impact of provider competencies and patient training on the effectiveness of the rehabilitation regimen, as well as efforts to identify the best approaches to mitigate secondary health deficits, are encouraged. 
  • Support standardized assessment of patient outcomes related to prosthetics and orthotics. Applications submitted to this goal should seek to validate function and performance, community integration, and user satisfaction outcomes associated with various device properties and functional abilities. An important objective of this goal is to enhance the understanding of the outcomes that matter most for individuals living with orthotic and prosthetic devices. 

Award Mechanism Eligibility Key Mechanism Elements Funding
Clinical Research Award Independent investigators at all academic levels (or equivalent)
  • Supports clinical research but not clinical trials.
  • Research projects may include (but are not limited to) methodologies and designs such as questionnaires, observational studies, or meta-analysis and systematic reviews that focus on outcomes related to the FY23 OPORP Strategic Goals.
  • Preclinical studies using animals are not allowed.
  • Research Level 1 supports pilot research studies that have the potential to make significant advancements toward clinical translation. Preliminary data are encouraged but not required for this Research Level.
  • Research Level 2 supports research that has the potential to make significant advancements toward clinical translation. Proposed projects may include large-scale studies that will produce high-quality outcomes and provide strong support for evidence-based practice and/or have the potential to drive changes in clinical practice. Preliminary data and/or published data that are relevant to orthotic and/or prosthetic device outcomes and support the rationale for the proposed research are required.
  • New for FY23: Participation of at least one limb loss or limb impaired patient/consumer as a consultant or member of the research team to contribute to the development of the research question, project design, oversight, evaluation, and/or other significant aspects of the proposed project is encouraged for Research Level 1 and required for Research Level 2.
 Research Level 1
  • Maximum funding of $400,000 for total costs (direct plus indirect costs)
  • Maximum period of performance is 2 years
Research Level 2
  • Maximum funding of $2 million (M) for total costs (direct plus indirect costs)
  • Maximum period of performance is 4 years
Clinical Trial Award Independent investigators at all academic levels (or equivalent)
  • Supports clinical trials with the potential to have a significant impact on improving the health and well-being of individuals with limb loss and/or limb impairment.
  • Preclinical research is not allowed.
  • Research Level 1 supports pilot and early-stage clinical trials that are exploratory and involve limited human exposure (i.e., small sample size) with the potential to make significant advancements toward clinical translation. Preliminary data, published or unpublished, are required.
  • Research Level 2 supports large clinical trials with the potential to make significant advancements toward clinical translation. Proposed projects may include large-scale trials that will produce high-quality outcomes with robust, statistically significant participation to provide strong, definitive support for evidence-based practice and/or have the potential to drive changes in clinical practice. Pragmatic clinical studies, randomized controlled trials, and comparative effectiveness studies are welcome and encouraged. Preliminary data relevant to the proposed clinical trial are required.
  • New for FY23: Participation of at least one limb loss or limb impaired patient/consumer as a consultant or member of the research team to contribute to the development of the research question, project design, oversight, evaluation, and/or other significant aspects of the proposed project is encouraged for Research Level 1 and required for Research Level 2.
 Research Level 1
  • Maximum funding of $400,000 for total costs (direct plus indirect costs)
  • Maximum period of performance is 3 years
Research Level 2
  • Maximum funding of $4M for total costs (direct plus indirect costs)
  • Maximum period of performance is 4 years

A pre-application is required and must be submitted through the Biomedical Research Application Portal (eBRAP) prior to the pre-application deadline. All applications must conform to the final funding opportunity announcements that will be available for downloading from the Grants.gov website. The application package containing the required forms for each award mechanism will also be found on Grants.gov. A listing of all CDMRP and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.

Submission deadlines are not available until the funding opportunity announcements are released. For email notification when announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage. For more information about the OPORP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.health.mil).


Point of Contact:

CDMRP Public Affairs
301-619-9783
usarmy.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@health.mil


Last updated Sunday, December 31, 1600