NCT03891641终止不适用
A Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility in Patients With Peripheral Arterial Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in Overground Walking Speed After Intervention
研究概览
简要总结
This is a pilot study of a new exercise device (TREDLR) designed to facilitate repetitive ankle flexion/extension movements (i.e., "treadling") through a momentum-driven internal flywheel while seated. The specific goals of this project are to explore improvements in mobility and exercise capacity in individuals who treadle compared to a control group.
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
- None
盲法说明
No Masking
入排标准
- 年龄范围
- 65 Years 至 99 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able to walk without an assistive aid (i.e., walker, cane)
- •Have the capacity the provide written informed consent
- •Have previously diagnosed peripheral arterial disease (by self-report)
排除标准
- •Lower extremity injury or fracture within the last 6 months
- •Have a leg prosthesis
- •Prisoners
- •Individuals clearly lacking the capacity to provide informed consent
- •Vestibular impairment
研究组 & 干预措施
Treadling Group
Experimental
Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks.
干预措施: Treadwell Tredlr (Behavioral)
Control Group
No Intervention
Control Subjects continue their normal daily activities.
结局指标
主要结局
Change in Overground Walking Speed After Intervention
时间窗: Baseline, 6 weeks
Measured from the time taken to walk 6 meters.
Change in 6-min Walk Distance
时间窗: Baseline, 6 weeks
Measured from the distance walked in 6 minutes.
次要结局
- Change in Stride Length(Baseline, 6 weeks)
- Change in Peak Ankle Power(Baseline, 6 weeks)
研究者
研究点 (1)
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