Saving Life and Limb: Functional Electrical Stimulation for the Elderly With Peripheral Artery Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Change from initial assessment, baseline, end of intervention and final assessment using the 6 Minute Walk Test
研究概览
简要总结
This study will take the first step to improve public health for millions of Americans with Peripheral Arterial Disease who have extreme difficulty walking due to leg pain. The investigators will assess a proof of concept, home administered, functional electrical stimulation (FES) system to resolve pain, improve walking, and enhance quality of life.
详细描述
This study will evaluate an innovative approach to reduce the debilitating symptoms of peripheral arterial disease (PAD) and ischemic pain during walking (intermittent claudication) by using a new Functional Electrical Stimulation (FES) system. The investigators hypothesize that combining the FES and walking one hour/day (FES+Walk) will significantly reduce pain during walking, improve locomotion, and enhance quality of life when compared to walking one hour/day (Walk) alone after 8 weeks of intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who:
- •Are ambulatory, community dwelling adults with evidence of PAD including ankle/brachial index ABI=0.4-0.9
- •Have symptom severity of Fontaine stage II-III
- •Have a score of 24 or higher on the Folstein Mini Mental test
- •Have visible muscle contraction of the plantar flexor (PF) and dorsiflexor (DF) muscles using FES
排除标准
- •Patients who:
- •Have an electronic implanted stimulator such as pacemaker, defibrillator, deep brain stimulator, spinal cord stimulator
- •Are pregnant
- •Cannot walk without a walker or require human assistance to walk,
- •Present with arthritis or neurological damage resulting in paresis or paralysis of the lower extremity
- •Have skin lesion(s) on the legs where the FES is placed
结局指标
主要结局
Change from initial assessment, baseline, end of intervention and final assessment using the 6 Minute Walk Test
时间窗: Initial, baseline assessment, assessment at the end of 8 weeks intervention, and final assessment at 16 weeks (8 weeks post- intervention)
We will measure the changes in distance walked during the 6 minute walk test
Change from initial assessment, baseline, end of intervention and final assessment using the Peripheral Artery Disease Quality of Life Questionnaire
时间窗: Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post- intervention)
We will record and measure the changes in questionnaire scores from baseline to end of intervention and end of post-intervention
Change from initial assessment, baseline, end of intervention and final assessment using the Perceived Pain Intensity Scale
时间窗: Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post-intervention)
We will measure the changes in pain scores from baseline to end of intervention and end of post-intervention
次要结局
- Change from initial assessment, baseline, end of intervention and final assessment using the Timed-Up-and-Go test(Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post- intervention))
- Change from initial assessment, baseline, end of intervention and final assessment using the Intermittent Claudication Questionnaire (ICQ)(Initial, baseline assessment, assessment at the end of 8 weeks intervention and final assessment at 16 weeks (8 weeks post- intervention))