权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

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

开发用于量化软组织操作评估和干预过程中的力的创新医疗器械技术

基本信息

批准号：
10256564
负责人：
Sohel Anwar
金额：
$ 25.61万
依托单位：
HEALTH SMART TECHNOLOGIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-04-01 至 2022-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10256564
关键词：
Acute Address Affect Area Athletic Back Biological Biomechanics Businesses Caring Cellular Phone Chiropractor Clinic Clinical Clinical Treatment Clinical Trials Clinical assessments Complement Complementary Health Computer software Consult Custom Data Descriptor Development Device Designs Devices Discipline Documentation Dose Edema Effectiveness Elbow Evaluation Exercise Feedback Fingers Functional disorder Goals Health Health Priorities Industry Inflammation Injury Integrative Medicine Intervention Intervention Studies Knowledge Language Lead Manipulative Therapies Manuals Marketing Massage Measurement Measures Mechanics Medical Device Methods Modality Modeling Monitor Motion Musculoskeletal Pain Occupations Outcome Outcome Study Output Pain Pain Measurement Pain Threshold Patients Pattern Perception Phase Physicians Population Provider Rehabilitation therapy Reproducibility Research Research Personnel Rheumatism Sales Small Business Technology Transfer Research Sports Standardization Stroke System Technology Telephone Testing Therapeutic Thigh structure Tissues Training United States National Institutes of Health Variant Veterinarians Veterinary Medicine Visualization aged chronic musculoskeletal pain commercialization compare effectiveness data access design digital education research fitbit functional outcomes improved injured innovation innovative technologies instrument interest mimetics novel osteopath phase II trial physical therapist pressure response soft tissue software systems usability

项目摘要

PROJECT SUMMARY 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.

项目摘要缺乏一种方法来量化软组织操作（STM）的运动和剂量，如在临床上提供的是一个这种非侵入性和非药理学的可重复性和治疗潜力的关键问题模态STM是一种用于评估和治疗肌肉骨骼疼痛，炎症和疼痛的手动治疗形式。功能障碍不同的软组织力具有不同的生物学效应和结局。有证据表明STM 可以作为运动的替代或增强，这对康复具有重要意义。像锻炼一样，最佳STM剂量需要客观参数。然而，初步研究表明，在治疗师内部和治疗师之间，STM力量应用的不一致性，而定量反馈显著提高其准确性和一致性。不幸的是，目前的STM实践主要依赖于主观处理软组织质量和疼痛的变量和模糊描述符。评估和治疗的不必要变化可能会损害结果并降低实践的价值。我们迫切需要一种技术，生成STM指标，通过提供一种通用语言来优化STM检查，干预，使剂量处方，促进培训，研究其影响，并评估结果。我们的团队开发了一种新型医疗器械系统，可量化软组织操作（QSTM™）作为解决手法治疗中这一空白的一种方法。QSTM™包括用于该应用的装置（Q1），感测较小区域中的局部力（例如，手指或肘部）和另一个分散力的装置（Q2）在较大的区域（例如，背部或大腿），沿着用于记录和分析治疗数据的定制软件，包括STM力的大小、角度、速率和方向。这项建议的主要目的是证明QSTM™用于临床的可行性。核心假设是QSTM™将改善 STM检查和干预的可重复性。项目目标旨在优化设备的设计系统;定量表征基本STM中风运动模式;测试STM力应用的可靠性使用QSTM™数据输出;并确定其用于疼痛评估的可用性。有一个巨大的市场， QSTM™在多个健康学科，体育，教育，研究和兽医。人员和付款人寻求精确的、以病人为中心的护理将最终推动市场。QSTM™代表了一项重大改进与传统的手工方法相比，无论是否使用刚性器械或模拟装置。QSTM™ 提供了其他方法的替代或补充。我们已经就我们的商业模式咨询了专家以及市场营销和销售策略。该项目与国家补充和综合中心保持一致卫生优先事项。NIH的支持将加速商业化。QSTM™用于手动治疗，就像Fitbit用于锻炼的QSTM™通过客观的测量和目标设定，更好地实现个性化康复，记录、监控和再现性。这项先进的技术将整合患者反馈和临床医生通过量化指标改善感知，为软组织手动治疗实践向数字化时代的积极转变。