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Development of Innovative Medical Device Technology for Quantifying Forces during Soft Tissue Manipulation Assessment and Intervention

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AT011494-01
Agency Tracking Number: R41AT011494
Amount: $256,129.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: R
Solicitation Number: PA20-265
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-04-01
Award End Date (Contract End Date): 2022-03-31
Small Business Information
Carmel, IN 46033-9571
United States
DUNS: 080315429
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (317) 278-3463
Business Contact
Phone: (317) 443-0696
Research Institution
United States

 Nonprofit College or University

The lack of a means to quantify soft tissue manipulation (STM) motion and dose as delivered in the clinic is a
critical problem in the reproducibility and therapeutic potential of this non-invasive and non-pharmacological
modality. STM is a form of manual therapy used to evaluate and treat musculoskeletal pain, inflammation, and
dysfunction. Different soft tissue forces have differing biological effects and outcomes. Evidence suggests STM
may serve as a surrogate or augment to exercise, which has important implications in rehabilitation. Like exercise,
objective parameters are needed for optimal STM dosing. However, initial research indicates a high level of
inconsistency in STM force application, both within and between therapists, while quantitative feedback significantly
improves its accuracy and consistency. Unfortunately, current STM practice relies mostly on subjective treatment
variables and vague descriptors of soft tissue quality and pain. Unwarranted variation in assessment and treatment
can compromise outcomes and diminish the value of the practice. There is a strong need for technology that can
generate STM metrics to improve practice by providing a common language to optimize STM examination and
intervention, enable dose prescriptions, facilitate training, study its effects, and evaluate outcomes.Our team has developed a novel medical device system, Quantifiable Soft Tissue Manipulation (QSTM™)
as a solution to address this void in manual therapy. QSTM™ includes a device (Q1) for the application and
sensing of localized forces in smaller regions (e.g., finger or elbow) and another device (Q2) for dispersive forces
in larger regions (e.g., back or thigh), along with custom software for recording and analysis of treatment data,
including STM force magnitude, angle, rate, and direction. The primary purpose of this proposal is to
demonstrate the feasibility of QSTM™ for clinical use. The central hypothesis is that QSTM™ will improve the
reproducibility of STM examination and intervention. Project objectives aim to optimize the design of the device
system; quantitatively characterize basic STM stroke motion patterns; test the reliability of STM force application
using QSTM™ data output; and determine its usability for pain assessment. A large market exists for use of
QSTM™ in multiple health disciplines, sports, education, research, and veterinary medicine. People and payers
seeking precise, patient-centric care will eventually drive the market. QSTM™ represents a significant improvement
over its competition of traditional manual methods, with or without rigid instruments, or mimetic devices. QSTM™
offers an alternative or complement to other approaches. We have consulted with experts on our business model
and marketing and sales strategies. This project aligns with the National Center of Complementary and Integrative
Health priorities. NIH support will accelerate commercialization. QSTM™ is to manual therapy what the Fitbit is to
exercise. QSTM™ better enables individualized rehabilitation through objective measures and goal setting,
recording, monitoring, and reproducibility. This progressive technology will integrate patient feedback and clinician
perception with quantitative metrics, creating a positive shift to the digital era of soft tissue manual therapy practice.PROJECT NARRATIVE
The lack of a means to quantify soft tissue manipulation (STM), a form of manual therapy, is a critical barrier to the
reproducibility and optimization of this non-invasive and non-pharmacological modality in the management of acute
and chronic musculoskeletal pain, inflammation, and injury. Health Smart Technologies, Inc. has developed a novel
quantifiable soft tissue manipulation (QSTM™) device system for the manual application and measurement of
localized and dispersive forces, addressing the need for objective metrics in connectivity with patient feedback and
clinician perception, aimed to improve STM clinical assessment and treatment, training, and research. This STTR
Phase I project objectives are to optimize the design of QSTM™ device system, characterize STM stroke patterns
with quantitative parameters, test the reliability of targeted STM force application, and evaluate the usability of this
technology for pain assessment, moving the field into the digital era of soft tissue manual therapy.

* Information listed above is at the time of submission. *

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