Cervical Muscle Diagnostic and Conditioning System for Injury Rehabilitation and Prevention

用于损伤康复和预防的颈肌诊断和调理系统

• 批准号: 10480354
• 负责人: James McInnes
• 金额: $ 25.92万
• 依托单位: ORTHOPEDIC WELLNESS LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-20 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10480354
• 关键词: Acute; Affect; Analgesics; Anatomy; Area; Articular Range of Motion; Cervical; Cervical spine; Cervix Diseases; Chiropractor; Clinical; Complex; Custom; Data; Development; Device Designs; Devices; Diagnosis; Diagnostic; Dimensions; Educational Intervention; Electromagnetics; Enrollment; Evaluation; Exercise; Functional disorder; Future; Geometry; Guidelines; Hand; Head; Head and neck structure; Health; Health Status; Human; Individual; Injury; Insurance; Intervention; Joints; Laboratories; Lead; Life; Link; Measures; Medical; Medical Care Costs; Medical Device; Methods; Motion; Movement; Muscle; Muscle relaxants; Nature; Neck; Neck Pain; Orthopedics; Pain; Patients; Performance; Persons; Phase; Physical therapy; Prevention; Productivity; Protocols documentation; Recovery; Recurrence; Rehabilitation device; Rehabilitation therapy; Research; Resistance; Resolution; Rotation; Safety; Shapes; Signs and Symptoms; Skeletal muscle structure of neck; Small Business Innovation Research Grant; System; Technology; Testing; Time; Tissues; Training; Visit; Weight; Work; accurate diagnosis; accurate diagnostics; base; chiropracty; clinical practice; compliance behavior; conditioning; design; disability; evidence base; experience; healthy volunteer; human subject; improved; injured; innovation; laboratory equipment; muscle strength; muscular system; pain relief; persistent symptom; personalized care; physical therapist; pressure; prevent; prototype; resistance mechanism; restraint; skeletal; strength training; time use; tool; traumatic event; usability; volunteer

PROJECT SUMMARY Neck pain, whether from a traumatic event or of a non-traumatic nature, is a leading cause of worldwide disability. In the US alone, medical costs associated with neck pain are the third highest bill for health-related conditions ($88 billion spent every year). Although acute neck pain resolves spontaneously over weeks and is well managed by painkillers and muscle relaxants, 50-70% of individuals experience chronic symptoms or recurrences 1–5 years after initial neck pain resolution. Therefore, 19.1 million patients visit every year a chiropractor or physical therapist to perform exercises for neck rehabilitation. Strong evidence supports that cervical muscle training helps to relieve pain, restore range of motion (ROM), and reinforce the musculature of the neck to prevent disabilities and injuries. Nonetheless, traditional rehabilitation approaches are not effective as they rely only on a “good enough” approach rather than evidence-based methods. Current clinical guidelines involve the use of provocative tests, Cervical Range of Motion (CROM) devices, goniometers, or hands for neck disability diagnosis, and bands, hands, or weight pressure for conditioning and strengthening exercises. However, these tools provide inaccurate and inconsistent data and are unsafe and inefficient to fully resolve the problem. Orthopedic Wellness Laboratories (OWL) will change the current paradigm, introducing the first medical device based on an innovative, adjustable resistive mechanism, for accurate and efficient evaluation and rehabilitation of neck disabilities. The device consists of a head restraint configured to move in the sagittal, frontal, and transverse planes linked to a multi-axis modular resistance mechanism that can be set to create resistance to the user’s cervical motion. The device utilizes advances in technology and movement metrics to provide quantitative, accurate, and real-time data of the patient neck range of motion in three planes and allows to safely and precisely strengthen specific weak or injured areas without overloading them. The research proposed in this SBIR Phase I will be focused on the feasibility assessment of OWL’s technology. In particular, OWL will develop the first multi-axis cervical muscle prototype device designed to fit individuals with different neck and head physical dimensions and range of motion. The prototype will be tested for comfort and ease of use by volunteer subjects and physical therapists, and the ability to accurately measure the range of motion in a real-life diagnosis set-up. Future SBIR Phase II will focus on the development of a product market-ready and clinical intervention tests. Successful completion of this research will result in a new tool that will enable clinicians and physical therapists to provide accurate diagnoses, create customized patient exercises, increase practice throughput, identify the potential joint, disc, or skeletal dysfunctions earlier, and increase patient compliance to the neck rehabilitation treatment.

项目摘要 颈部疼痛，无论是创伤性事件还是非创伤性事件，都是全球残疾的主要原因。 仅在美国，与颈部疼痛相关的医疗费用是健康相关疾病的第三高账单 （每年花费880亿美元）。虽然急性颈部疼痛在几周内自发缓解，并得到良好的管理， 通过止痛药和肌肉松弛剂，50-70%的人经历慢性症状或复发1-5 在最初的颈部疼痛消退后数年。因此，每年有1910万患者访问脊椎按摩师或物理治疗师。 治疗师进行颈部康复训练。有力的证据表明，颈部肌肉训练 有助于缓解疼痛，恢复活动范围（ROM），并加强颈部肌肉组织，以防止 残疾和伤害。然而，传统的康复方法并不有效，因为它们仅依赖于 一种“足够好”的方法，而不是基于证据的方法。目前的临床指南涉及使用 刺激性测试、颈椎活动度（CROM）装置、测角器或颈部残疾手 诊断，和乐队，手，或重量压力的条件和加强练习。但这些 工具提供不准确和不一致的数据，并且对于完全解决问题是不安全和低效的。 骨科健康实验室（OWL）将改变目前的模式，推出第一个医疗设备 基于创新的、可调节的阻力机制，用于准确、高效的评估和康复 颈部残疾。该装置由头部保护装置组成，该头部保护装置被配置为在矢状、额状和 横向平面连接到多轴模块化阻力机制，可以设置为产生阻力， 用户的颈部运动。该设备利用技术和运动指标的进步， 患者颈部在三个平面内的运动范围的定量、准确和实时数据， 并精确地加强特定的薄弱或受伤区域，而不会使其过载。这项研究提出， SBIR第一阶段将侧重于OWL技术的可行性评估。特别是，OWL将开发 第一个多轴颈部肌肉原型设备，旨在适应不同颈部和头部的个人 物理尺寸和运动范围。原型将测试的舒适性和易用性的志愿者 受试者和物理治疗师，以及在现实生活诊断中准确测量运动范围的能力 安排未来的SBIR第二阶段将专注于开发产品市场和临床干预 试验.这项研究的成功完成将产生一种新的工具，使临床医生和物理学家能够 治疗师提供准确的诊断，创建定制的患者练习，增加实践吞吐量， 及早识别潜在的关节、椎间盘或骨骼功能障碍，并提高患者对颈部的依从性 康复治疗。