NCT06345781招募中不适用
Abdominal Functional Electrical Stimulation to Improve Bowel Function in Spinal Cord Injury
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Bowel Management Time (BMT)
研究概览
简要总结
The primary objective of this study is to gather information about the effectiveness of abdominal FES to improve bowel management time (BMT) for people with chronic SCI. This study will also evaluate whether abdominal FES can improve: 1) bowel-related quality of life, 2) participant-reported bowel function, 3) bowel management strategy, 4) bladder symptoms, and 5) unplanned hospital admissions. In addition, we will also explore participant perspectives and experiences about the stimulation sessions and use of the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic SCI (> 12 months since injury) above the level of T11
- •> 18 years of age
- •a measurable and consistent start and end event is determinable for the bowel routine
- •Start events include: 1) enema insertion, 2) digital stimulation, 3) hot drink or initiation of the gastrocolic reflex, 3) abdominal massage, or 4) other, as determined by the participant and research team.
- •Ending events include: 1) final digital stimulation, 2) when evacuation has ceased, or 3) other, as determined by the participant and research team.
- •Portable smart device with video capabilities and internet access
- •Willingness to access and/or download Zoom (videoconferencing software)
排除标准
- •American Spinal Injuries Association (ASIA) Impairment Scale (AIS) E
- •Self-reported bowel management time (BMT) of <30 minutes
- •Current bowel conditions such as gastro-esophageal reflux, bowel obstruction, Crohn's disease, or diverticulitis
- •Physical obstacles that prevent AFES (e.g., pregnancy, abdominal trauma, cardiac pacemaker, or other implanted electromedical devices)
- •Stoma or colostomy
- •No response to AFES (e.g., lower motor neuron impairment)
- •History of gastrointestinal surgery within the past 3 months
- •Severely obese participants (>40 BMI)
- •Primary language other than English
- •Previous history of uncontrolled, recurrent episodes of AD
- •Resting systolic blood pressure (BP) reported as >140 mmHg
结局指标
主要结局
Bowel Management Time (BMT)
时间窗: Daily (Weeks 1-10)
This is measured by recording start and end time of bowel management session in study diary.
次要结局
- EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Questionnaire(Week 1, Week 3, Week 7, Week 10)
- International Spinal Cord Society's (ISCoS) International SCI Bowel Function Basic Data Set Questionnaire(Week 1, Week 3, Week 7, Week 10)
- Intervention Acceptability(Week 7)
- Bowel Management Strategy(Daily (Weeks 1-10))
- Visual Analog Scale (VAS)(Week 1, Week 3, Week 7, Week 10)
- Intervention Safety(Daily (Weeks 0-10))
- Neurogenic Bladder Symptom Score (NBSS)(Week 1, Week 3, Week 7, Week 10)
- Stimulation Dose(During active stimulation period (Weeks 3-7))
研究者
Candace Tefertiller
Executive Director of Research and Evaluation
Craig Hospital
研究点 (2)
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