Interactive Telehealth and Auto-Biofeedback Sensor System for Pressure Ulcer Prevention After SCI
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- Sitting time
研究概览
简要总结
The goal of this module project is to establish the efficacy of a portable sensor and app-based biofeedback technology system for promoting effective pressure relief behaviors and reducing risk of pressure ulcer development among wheelchair users. In collaboration with the participating SCIMS centers, the investigators will conduct a randomized clinical trial of education and goal setting alone compared to education and goal setting combined with the biofeedback system (SENSIMAT®) that is commercially available.
详细描述
Overview and Rationale:
Pressure ulcers (PUs) are a frequent and serious secondary complication after SCI with an annual incidence of 31% and a lifetime incidence of up to 85%. PUs are linked to increased morbidity and mortality. As medical or surgical repair of established PUs is difficult and costly, the preferred approach is prevention. Traditional prevention recommendations included intermittent relief of interface pressure, such as performing wheelchair (WC) pushups every 30 minutes for 30 seconds or once an hour for 60 seconds. Alternatives to the push-up maneuver, including forward and lateral trunk leans, have been recommended to reduce the demands of weight bearing on the shoulders. One approach to address inadequate PR is to provide a simple reminder (i.e., an alarm) at set intervals. However, this approach is inadequate because patients who attempt PR maneuvers often do not achieve an adequate magnitude or duration of PR for tissue unloading. In addition, compliance with PR performance can be negatively impacted by unanticipated life circumstances. A system to measure PR maneuvers in the home and community and provide reminders and feedback on frequency and success of individual attempts of this important preventative activity could reduce the incidence of PUs. In this collaborative project, the investigators will establish the efficacy of a sensor and feedback technology system for promoting effective pressure relief behaviors and reducing risk of pressure ulcer development among wheelchair users. The investigators will conduct a randomized clinical trial of education and goal setting alone compared to education and goal setting combined with the biofeedback system (sensor and smartphone app) that is developed and validated. The fully functional system is unobtrusive and simple. The system attaches to any WC (without modification) and generates automatic reminders via an app. Biofeedback, also delivered via the app, indicates in real time when a PR maneuver has been completed successfully. The display also tracks the user's daily PR activity as the participants works towards a daily goal.
Specific Aims:
Primary: Compare PR behavior (daily PR frequency and average duration of uninterrupted sitting) between participants who receive education and four weeks of biofeedback training with the monitoring system (intervention group) and those who receive education but no system feedback (control group). Secondary: Compare the incidence of ischial PU development at one year post-intervention between groups.
Hypotheses:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Following the training/goal setting session, participants will be randomly assigned into either the intervention group that will receive biofeedback via the smartphone app for 4 weeks, or the control group that will continue to have the WC sensor system for measurement only and will not receive biofeedback.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons with documented SCI, American Spinal Injury Association Impairment Scale (AIS) A, B, or C.
- •Persons who are full time manual wheelchair users.
- •persons over the age of
- •2-6 months post-injury.
- •Able to perform pressure relief maneuvers without assistance
- •Cognitively able to understand and sign informed consent form approved by the IRB
- •Free of shoulder pain that interferes with daily activities or requires medical intervention at the time of enrollment in the study
排除标准
- •History of shoulder injury or surgery or orthopedic or neurologic disorders (other than SCI) that would impact arm function, preventing them from performing pressure ulcer relief maneuvers or propelling a wheelchair.
- •history of ischial pressure ulcer.
研究组 & 干预措施
Control Group
The control group will continue to have the WC sensor system for measurement only and will not receive biofeedback after receiving instructions on the importance of pressure relief (PR) maneuvers for skin care, as well as training regarding the three pressure relief maneuvers. Materials (including fact sheets, etc.) will be incorporated in the educational content of the project.
Intervention Group
The intervention group will receive biofeedback via the smartphone app.
干预措施: Pressure Relief Monitoring System (Device)
结局指标
主要结局
Sitting time
时间窗: 8 weeks
Duration of uninterrupted sitting time in minutes per day
PR maneuvers per day
时间窗: 8 weeks
Number of pressure relief maneuvers per day
次要结局
- Pressure Ulcer Occurence(1 year)
研究者
Sara Mulroy
Co-Director
Rancho Research Institute, Inc.