Pressure Relief System for Preventing Pressure Ulcers

描述(申请人提供)：长时间坐在轮椅上而没有适当地重新定位会导致坐骨结节和尾骨上的压力过大，显著增加压疮(PU)的风险，这对长期坐在轮椅上的人群的成本、生活质量和功能活动造成了巨大的负担。压力未缓解已被确定为长期护理居民发生PU的主要病因。我们建议评估一种新的轮椅座椅设计，在这种设计中，座椅的后部可以相对于座椅的前部动态向下倾斜，从而能够释放坐骨上的坐面压力。该机制在受控坐位中引入了一个新的概念，并已被证明有能力极大地释放坐骨下的坐位界面压力，并促进组织存活。因此，我们计划评估这种坐位机制在降低轮椅脊髓损伤(SCI)患者的PU风险和加快PU愈合率方面的作用。从长远来看，我们希望它能帮助长期轮椅使用者提高生活质量，提升功能状态。 具体目标1：评价轮椅坐过程中臀部大腿与座椅、靠背与靠背之间的压力分布以及座椅与靠背的载荷转移，并与普通轮椅坐姿进行比较。 具体目的2：通过测量组织血流和皮肤温度的变化来评估组织活性，并与通常的轮椅坐加临床推荐的俯卧撑方案进行比较。 针对具体目标1和2，将对两组患有脊髓损伤的轮椅使用者进行研究，包括慢性和急性。 具体目标3：评估使用配备该机制的轮椅时的PU愈合率，并与通常的轮椅坐加俯卧撑进行比较。将包括一组患有脊髓损伤的轮椅使用者，他们在休息区发展了PU。当使用所提出的坐姿机制时，将进行为期4周的PU愈合过程评估，并将其与使用常规轮椅的类似患者的对照组进行比较。 具体目的4.评估轮椅与通常坐姿加临床推荐俯卧撑坐姿相比的坐姿喜好。所有纳入上述研究的患者将被要求完成一份关于建议机制中与坐姿相关的舒适性和耐受性的主观评价问卷，并与通常的轮椅进行比较。

DESCRIPTION (provided by applicant): Prolonged sitting without proper repositioning in a wheelchair results in excessive pressure over the ischial tuberosities and coccyx significantly increasing the risk of pressure ulcers (PU), which impose a tremendous burden in terms of cost and the quality of life and the functional activities of the long-term wheelchair-bound population. Unrelieved pressure has been identified as the major etiological factor of developing PU for long-term care residents. We propose to evaluate a new seat design for wheelchair, in which the back part of the seat can be dynamically tilted downward with respect to the front part of the seat to be able to release the sitting interface pressure over the ischium. The mechanism introduces a novel concept in controlled sitting and has been demonstrated the capability to largely release the sitting interface pressure under the ischium and promote tissue viability. Therefore, we plan to evaluate this sitting mechanism in reducing the PU risk and accelerating PU healing rate in wheelchair-bound spinal cord injury (SCI) patients. In the long run, we expect it to help increase the quality of the life and promote functional status for long time wheelchair users. Specific aim 1: To evaluate sitting interface pressure distributions between the buttock-thighs and seat, between the back and backrest, and the load shift on the seat and back, during sitting in the proposed wheelchair and compare with those of usual wheelchair sitting. Specific aim 2: To evaluate tissue viability by way of measuring tissue perfusion and skin temperature changes during sitting with wheelchair equipped with the proposed mechanism and compare with those of usual wheelchair sitting plus clinically recommended Push-up regimen. Research for specific aim 1 and 2 will be carried out on 2 groups of wheelchair users with SCI, chronic and acute. Specific aim 3: To evaluate PU healing rate when using wheelchair equipped with the proposed mechanism and compare with those of usual wheelchair sitting plus push-ups. A group of wheelchair users with SCI who have PU developed in sitting area will be included. A 4-week PU healing process evaluation will be carried out when using the proposed sitting mechanism and comparing that with a controlled group of similar patients using regular wheelchair. Specific aim 4." To evaluate the preferences in sitting posture when sitting with wheelchair equipped with the proposed mechanism versus sitting in the usual posture plus clinically recommended Push-up regimen. All patients included in the above studies will be asked to complete a questionnaire for subjective evaluation about the comfort and tolerance related sitting in the proposed mechanism and compare it with the usual wheelchair