High vs Low-frequency of High-intensity Training in Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 6-minute walk test
研究概览
简要总结
The purpose of this pilot study is to investigate the potential role of training frequency on locomotor outcomes following high-intensity gait training and provision of a home walking program.
详细描述
This study will utilize a 2 arm randomized trial to investigate potential differences in locomotor and community outcomes following 18 visits of high-intensity gait training provided over 6 weeks (high frequency) or 12 weeks (low frequency). Following confirmation of eligibility and baseline testing, individuals will be randomized to either high or low frequency of training and complete subsequent testing at 6 weeks, 12 weeks, and 24 weeks.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral deficits following stroke > 6 months prior; however individuals > 4 months post-stroke are eligible for consenting, but final eligibility and potential enrollment will not occur until > 6 months
- •Age 18-85
- •Weight < 350 pounds
- •Able to follow 3-step commands
- •Able to ambulate with self-selected gait speeds between 0.10-1.0 m/s without physical assistance, but with below knee bracing and/or assistive device as needed
- •Lower extremity Fugl-Meyer < 34
- •Medical clearance to participate
排除标准
- •Evidence of cerebellar ataxia
- •Uncontrolled cardiopulmonary or metabolic disease that limits exercise participation, active heterotopic ossification, recurrent history of lower extremity fractures, previous orthopedic or other peripheral or central neurologic injury that may impair locomotor activities such that, in the judgement of the PI, could compromise the safety of the participant, limit the ability to complete the study, or compromise the objectives of the study.
- •Currently participating in other physical therapy
- •>50 units of Botox in the lower extremity OR in the lower extremity, but above the knee if the participant wears an ankle-foot-orthosis (AFO) within the past three months
研究组 & 干预措施
Low frequency
Individuals will receive up to 18 visits of high-intensity gait training and activity coaching over 12 weeks
干预措施: Physical activity coaching (Behavioral)
High frequency
Individuals will receive up to 18 visits of high-intensity gait training and activity coaching over 6 weeks
干预措施: high-intensity gait training (Other)
High frequency
Individuals will receive up to 18 visits of high-intensity gait training and activity coaching over 6 weeks
干预措施: Physical activity coaching (Behavioral)
Low frequency
Individuals will receive up to 18 visits of high-intensity gait training and activity coaching over 12 weeks
干预措施: high-intensity gait training (Other)
结局指标
主要结局
6-minute walk test
时间窗: After 12 weeks
Individuals will be asked to "cover as much ground as possible" over 6 mins. Heart rate will additionally be measured during this assessment (distance in m)
次要结局
- Peak treadmill speed(After 12 weeks)
研究者
George Hornby
Professor
Indiana University