Developing a Feedback-Controlled Heated Vest to Address Thermoregulatory Dysfunction in Persons with Spinal Cord Injury

开发反馈控制加热背心以解决脊髓损伤患者的体温调节功能障碍

• 批准号: 9816585
• 负责人: John P Handrakis
• 金额: --
• 依托单位: JAMES J PETERS VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-11-01 至 2021-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9816585
• 关键词: Activities of Daily Living; Address; Adult; Adverse effects; Area; Awareness; Biomedical Engineering; Body Temperature; Cervical spinal cord injury; Clinical; Cognitive; Color; Deterioration; Devices; Digit structure; Distal; Effectiveness; Ensure; Environment; Environmental Wind; Esthesia; Exposure to; Feedback; Feeling; Functional disorder; Goals; Heating; Hot Spot; Hour; Humidity; Impaired cognition; Impairment; Individual; Intelligence; Interruption; Intervention; Investigation; Limb structure; Maintenance; Measures; Medical; Motor; Normal Range; Pathway interactions; Performance; Persons; Physiological; Pilot Projects; Positioning Attribute; Prospective Studies; Quadriplegia; Quality of life; Reporting; Safety; Seasons; Secondary to; Self Care; Sensory; Shivering; Side; Skin Temperature; Social Work; Socialization; Speed; Spinal cord injury; Sunlight; Surface; Temperature; Testing; Thermogenesis; Veterans; Work; cognitive performance; design; efficacy study; efficacy testing; experience; improved; natural hypothermia; novel; prevent; prototype; recruit; response; safety study; safety testing; sound; thoracic vertebra bone structure; vasoconstriction

Persons with spinal cord injury (SCI), particularly [cervical injuries (tetraplegia]), are unable to effectively regulate core body temperature (Tcore) due to interruption of motor, sensory, and sympathetic pathways. Thus, control of distal extremity vasoconstriction (heat conservation) and shivering thermogenesis (heat production) are impaired, and the ability to maintain a constant Tcore is compromised. Persons with tetraplegia often report “feeling cold,” frequently present with subnormal Tcore (35-36.5°C), and are particularly vulnerable to hypothermia (Tcore<35°C) and associated impairment in cognitive performance, even when exposed to temperatures that are comfortable for able-bodied (AB) individuals. Cool seasonal temperatures have been shown to have a greater adverse effect on personal comfort, activities of daily living (ADLs), and vital daily activities in persons with tetraplegia than that of AB controls. Conversely, a minimal increase in Tcore from subnormal to normothermia, secondary to ambient heat may improve cognitive performance. Interventions addressing the tendency to poikilothermia and enhanced vulnerability to hypothermia in persons with [tetraplegia] are limited. Therefore, exploration of safe and efficacious bioengineering solutions to address the physiological, cognitive, and quality of life (QoL) issues associated with the routine exposure to cool temperatures that persons with [tetraplegia] often encounter is warranted. The goals of this pilot study in persons with [tetraplegia] are: 1) to study the safety and tolerability of a feedback-controlled heated vest and then 2) to study the efficacy of this heated vest to minimize the expected decline in Tcore and associated deterioration of cognitive performance during 2 hours of cool exposure. This single-group (persons with [tetraplegia]), two-condition (heated vest, non-heated vest) prospective study is being proposed to compare the physiological and cognitive responses to controlled cool exposure (18°C) with a prototype heated vest vs. a non-heated vest (control condition). [Eight] subjects with [tetraplegia (C3-T1], AIS A and B) and [eight] AB controls will be recruited for study participation. AB subjects will be observed to ensure the safety of the vest, which will be accomplished by determining the temperatures of the vest and subjective thermal sensation of less than “hot” during a cool condition that will be identical to that to which subjects with SCI will be exposed. Subjects with [tetraplegia] will test the efficacy of the heated vest, i.e. preventing the expected decline in Tcore and cognitive performance and increased thermal comfort. Primary Specific Aim: In a cool thermal chamber (18°C), AB controls will wear the heated vest at maximal setting for 120 minutes in the seated position to determine (1) maximum temperatures of all areas of the interior (user’s side) of the heated vest and (2) subjective comfort of the heated vest (safety testing). Primary Hypotheses: (1) 100% of the interior surface of the vest will have temperatures ≤38°C. (2) 100% of AB controls will report a thermal sensation of only “warm” and not “hot”. (3) 100% of AB controls will not report any areas of concentrated heat, e.g. “hot” spots (Zhang 9-point Thermal Sensation Scale). Secondary Specific Aim: During exposure to a cool environment (18°C) for up to 120 minutes in the seated position, persons with [tetraplegia] will wear the heated vest to determine (1) change in Tcore, (2) change in cognitive performance, and (3) change in thermal comfort (efficacy testing). Secondary Hypotheses: In persons with [tetraplegia] wearing the heated vest compared to the same persons wearing the non-heated vest, it’s expected that (1) 30% of the subjects will have a decline of at least 0.5°C in Tcore compared with 80% in the control condition, (2) 30% of the subjects will demonstrate a decline of at least 1 T-score in at least one of the following measures: Interference of Stroop Color and Word test, Digit Span of Wechsler Adult Intelligence Scale-Fourth Edition, compared with 80% in the control condition, and (3) a greater percentage of subjects reporting increased thermal comfort (Zhang 6-point Comfort Scale).

脊髓损伤的人（SCI），尤其是[宫颈损伤（四方]），无法有效 由于电动机，感觉和交感神经途径的中断，调节核心体温（TCORE）。 那是控制远端末端血管收缩（节能）和发抖的热发生（热量 生产受损，并且维持恒定TCORE的能力受到损害。四边形的人 经常报告“感觉很冷”，经常出现亚正常Tcore（35-36.5°C），并且特别脆弱 体温过低（Tcore <35°C）和认知表现的相关损害，即使暴露于 适合健全的（AB）个体的温度。凉爽的季节性温度已经 证明对个人舒适，日常生活（ADL）和每天至关重要的活动有更大的不利影响 与AB对照相比，具有四边形的人的活动。相反，从 与正常热的亚热症相比，其继发于环境热可以改善认知性能。干预措施 解决毒液症的趋势，并增强了患有体温过低的脆弱性 [四方]受到限制。因此，探索安全有效的生物工程解决方案，以解决 与常规暴露有关的身体，认知和生活质量（QOL）问题（QOL）问题 有必要遇到的人经常遇到的人的温度是有必要的。 这项试验研究的目标是[四方]的人：1）研究A的安全性和耐受性 反馈控制的加热背心，然后2）研究此加热背心的效率以最大程度地减少预期 在冷暴露2小时内，TCORE的下降以及认知表现的相关定义。 这个单组（具有[四边形]的人），两条条件（加热背心，非加热背心）的前瞻性研究是 提议将其与受控冷却暴露（18°C）的物理和认知反应与 原型加热背心与非加热背心（控制条件）。 [八个]患有[四边形（C3-T1]，AIS的受试者 A和B）和[八个] AB对照将被招募进行研究参与。将观察到AB受试者以确保 背心的安全，这将通过确定背心的温度和主观来完成 在凉爽条件下，热感觉小于“热”，与受试者相同 SCI将暴露。具有[四边形]的受试者将测试加热背心的效率，即防止 TCORE和认知性能的预期下降并增加了热舒适性。 主要特定目的：在凉爽的热室（18°C）中，AB控件将最大的加热背心磨损 设置在座位位置120分钟以确定（1）（1）所有区域的最高温度 加热背心的内部（用户侧）和（2）加热背心的主观舒适度（安全测试）。 主要假设：（1）背心的内部表面的100％的温度≤38°C。 （2）100％ AB控件将报告仅“温暖”而不是“热”的热感觉。 （3）100％的AB对照不会报告 任何浓缩热量区域，例如“热”点（张9点热感觉量表）。 次要特定目的：在接触凉爽的环境（18°C）期间，座椅最多120分钟 位置，患有[四边形]的人将佩戴加热背心以确定（1）Tcore的变化，（2）变化 认知性能和（3）热舒适度（功效测试）的变化。 次要假设：与同一个人相比 穿着非加热背心，预计（1）30％的受试者的下降至少为0.5°C TCORE与对照条件下的80％相比，（2）30％的受试者将表明至少下降 在以下至少一项措施中，1个T得分：Stroop颜色和单词测试的干扰，数字跨度 Wechsler成人智能量表第四版，而对照条件下为80％，（3）更大 报告的受试者的百分比增加了热舒适度（张6点舒适量表）。