The Use of Functional Electrical Stimulation in Conjunction With Respiratory Muscle Training to Improve Unaided Cough in Individuals With Acute Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Percentage change in peak cough flow (PCF)
研究概览
简要总结
The overall objective of this study is to improve unaided cough with abdominal and latissimus dorsi functional electrical stimulation in conjunction with respiratory muscle training in individuals with acute spinal cord injuries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Traumatic and atraumatic C2- T12 Spinal cord injury (AIS A, B, and C motor incomplete and complete injuries) currently admitted to inpatient rehabilitation with an injury date < 12 months prior to enrollment
- •Positive response to electrical stimulation through a palpable contraction
- •Fluent in written and spoken English
排除标准
- •Individuals who do not meet inclusion criteria
- •Concurrent traumatic brain injury determined by Rancho level of cognitive functioning < VI
- •Individuals with open tracheostomy
- •Persons with pacemakers
- •Pregnant women
- •Persons with epilepsy
- •Open wounds or metal implants at site of electrode placement
- •Unresponsive to functional electrical stimulation
- •Current diagnosis or history of thoraco-abdomino-pelvic cancer
研究组 & 干预措施
AFES and RMT Tetraplegia Group
Patients with a diagnosis of tetraplegia will receive co-treatment with abdominal functional electrical stimulation (AFES) and respiratory muscle training (RMT) for 4 weeks.
干预措施: Xcite Clinical Station (Device)
AFES and RMT Paraplegia Group
Patients with a diagnosis of paraplegia will receive co-treatment with abdominal functional electrical stimulation (AFES) and respiratory muscle training (RMT) for 2 weeks.
干预措施: Xcite Clinical Station (Device)
结局指标
主要结局
Percentage change in peak cough flow (PCF)
时间窗: one week pre-intervention and up to 4 weeks post-intervention
Assessing the percentage change in peak cough flow as assessed by peak expiratory flow meter with a pillow face mask.
Percentage change in peak expiratory flow
时间窗: one week pre-intervention and up to 4 weeks post-intervention
Assessing the percentage change in peak expiratory flow as assessed by peak expiratory flow meter with a pillow face mask.
次要结局
- Percentage change in forced expiratory volume in 1 second (FEV1)(one week pre-intervention and up to 4 weeks post-intervention)
- Percentage change in forced vital capacity (FVC)(one week pre-intervention and up to 4 weeks post-intervention)
- Change in cough effectiveness as measured by Likert Scale(one week pre-intervention and up to 4 weeks post-intervention)
- Percentage change in maximum expiratory pressure (MEP)(one week pre-intervention and up to 4 weeks post-intervention)
- Percentage change in maximum inspiratory pressure (MIP)(one week pre-intervention and up to 4 weeks post-intervention)
研究者
Stephane Philippe-ratway
Speech Pathologist
University of Miami