Rehabiliation of Lower Extremity Injury Patients Using a Weight Bearing Indicator

使用负重指示器进行下肢损伤患者的康复

• 批准号: 7053232
• 负责人: Daniel Francis Walczyk
• 金额: $ 11.15万
• 依托单位: TEAK INDUSTRIES, INC.
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-08-10 至 2008-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7053232
• 关键词: clinical research; clinical trial phase I; clinical trial phase II; hospitals; industry; injury; limbs; rehabilitation

DESCRIPTION (provided by applicant): The main objective of this Phase I STTR research and development effort is to test the clinical efficacy of a newly patented biomedical device, called a Snap Dome Weight Bearing Indicator (WBI), which is intended to provide a simple, effective, noninvasive and inexpensive device for patients with lower extremity injuries to self-monitor their weight bearing status as required by their physical rehabilitation program. The Snap Dome WBI was co-invented by the PI in 1998 and patented by Rensselaer Polytechnic Institute in 2002 [Walczyk et al.,2002]. Teak Industries in currently negotiating an exclusive rights licensing agreement with RPI. The WBI device is not yet a commercially viable product. The specific aims of this proposed 12-month STTR Phase I research project are to demonstrate the clinical efficacy of this product through a Phase I clinical trial at medical facilities in Albany, NY and Salem, NH. What will be demonstrated is: (1) how simple and inexpensive the Snap Dome WBI is to manufacture, (2) the easy integration of the WBI insert with various medical appliances that can be customized for each patient, (3) that the load transferred to the patient's limb is as expected, and (4) by using this product the mean number of days of hospital stay and rehabilitation can be reduced. If the Snap Dome WBI is shown to be effective, it will: -provide medical professionals (orthopedists, podiatrists, physical therapists) with an important, yet inexpensive tool to ensure that their patients comply with a prescribed physical rehabilitation program.-self-empower patients with an effective means to self-monitor their partial weight bearing status, and-drive down medical costs by reducing the occurrence of re-injury by a patient during rehabilitation.

描述（由申请人提供）：I阶段ISTTR研究和开发工作的主要目的是测试新专利的生物医学设备的临床功效，称为SNAP DOME负重轴承指示器（WBI），该指示器（WBI）旨在为较低的极端性伤害的较低性伤害的患者提供对重重的较重性轴承状态的简单，有效，非侵入性和廉价的病人，以使其对重重轴承的状态进行较重的状态。 Snap Dome WBI在1998年由PI共同发明，并于2002年获得Rensselaer理工学院的专利[Walczyk等，2002]。柚木行业目前与RPI谈判一项独家权利许可协议。 WBI设备还不是商业上可行的产品。该拟议的12个月STTR I期研究项目的具体目的是通过在纽约州奥尔巴尼市和纽约州奥尔巴尼市的医疗机构进行的I期临床试验来证明该产品的临床功效。将要证明的是：（1）Snap Dome WBI生产的简单和便宜，（2）WBI插入物与各种医用器械的容易整合可以为每个患者定制，（3）通过此产品的平均住院和重新固定的日期，（4）使用此产品，可以预期转移到患者的肢体上。如果显示出巨大的WBI有效，它将： - 提供医学专业人员（骨科医生，足病医生，物理治疗师）具有重要但廉价的工具，以确保患者遵守处方的身体康复计划。处方的自我康复计划。自助雇员的患者有效地将其纳入医疗成本的患者在劳动力中进行自我重新构成，并在劳动者身上进行自我责任，并遭受重新责任的责任，使其遭受重新锻炼，并遭受较高的体重，并遵守较重的责任，使其遭受重新训练的责任，使其遭受重新锻炼，并遵守较高的责任，使其遭受重新定位的责任，使其在较重的状态下进行，并遵守较高的体重，并将其重新调整，并遵守较重的责任。康复。