Ischemic Conditioning Improves Walking Function Post Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Self Selected Walking Speed
研究概览
简要总结
This innovative study will address scientific and clinical areas relatively unexplored in chronic stroke that could lead to greater recovery of walking. Ischemic Conditioning (IC) is a non-invasive, simple procedure that improves motor function, exercise performance and cardiovascular function in healthy controls, but it has never been applied to the stroke population. We postulate that IC enhances the recruitment of motoneurons and results in positive neural adaptations, improves vascular endothelial function and peripheral blood flow, and together these improvements result in an increased capacity to exercise and faster walking speed. Future studies will examine the effects of IC and traditional therapy at different time points of recovery post stroke, durability of IC, molecular mechanisms of neural and cardiovascular adaptation and the efficacy compared with other adjuncts.
详细描述
This study will quantify the effects of Ischemic Conditioning and treadmill training on improvements in: walking speed, leg strength, neuromuscular fatigability and the hyperemic blood flow response to muscle contractions, and vascular endothelial function and aerobic exercise capacity. A randomized control design will be used with three groups of chronic stroke survivors enrolled for four weeks of training (3x/week; 12 sessions total). The groups are: IC + Treadmill Training, IC Sham + Treadmill Training, and IC only. We will also enroll a group of age- and sex-matched healthy control subjects who will undergo IC + Treadmill Training. All Aims will be tested concurrently over a five-year period. All studies will be performed in Cramer Hall at Marquette University in the Integrated Neural Engineering Rehabilitation Laboratories, the Human Performance Assessment Core, and the Physical Therapy Clinic.
Randomization of stroke patients to the three intervention groups will be performed by using randomized block designs (randomly chosen block sizes of 3, 6 and 9). This number accounts for possible dropouts and the use of non- parametric methods.
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
- Triple (Participant, Investigator, 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
- 是
入选标准
- •(Stroke Survivors):
- •be ≥ 1 year post diagnosis of a unilateral, cortical stroke and have residual lower extremity paresis
- •be between the ages of 18-85
- •be able to give informed consent
- •walk slower than normative values based on age and sex
排除标准
- •(Stroke Survivors):
- •history of deep vein thrombosis or any condition in which transient ischemia to the lower extremity is contraindicated
- •inability to follow 2 step commands
- •chronic low back or hip pain
- •history of substance abuse
- •history of head trauma
- •comorbid neurological disorder
- •any uncontrolled medical condition
- •any condition where fatiguing contractions or resisted leg contractions are contraindicated
- •inability to walk for 5 minute bouts on a treadmill with a harness supporting up to 50% of the body weight at 80% of over-ground self-selected walking speed.
- •Inclusion Criteria (Healthy Control Subjects):
- •be between ages of 18-85
- •be able to give informed consent
- •Exclusion Criteria (Healthy Control Subjects):
- •Those listed above for stroke survivors
- •History of Stroke
研究组 & 干预措施
Ischemic Conditioning + Treadmill Training
Study participants with prior history of stroke will receive both ischemic conditioning and treadmill training.
干预措施: Treadmill Training (Procedure)
Ischemic Conditioning + Treadmill Training
Study participants with prior history of stroke will receive both ischemic conditioning and treadmill training.
干预措施: Ischemic Conditioning (Procedure)
Ischemic Conditioning Sham + Treadmill Training
Study participants with prior history of stroke will receive both ischemic conditioning sham and treadmill training.
干预措施: Ischemic Conditioning Sham (Procedure)
Ischemic Conditioning Sham + Treadmill Training
Study participants with prior history of stroke will receive both ischemic conditioning sham and treadmill training.
干预措施: Treadmill Training (Procedure)
Ischemic Conditioning Only
Study participants with prior history of stroke will receive only ischemic conditioning.
干预措施: Ischemic Conditioning (Procedure)
Healthy Control - Ischemic Conditioning + Treadmill Training
Healthy control participants will receive both ischemic conditioning and treadmill training.
干预措施: Ischemic Conditioning (Procedure)
Healthy Control - Ischemic Conditioning + Treadmill Training
Healthy control participants will receive both ischemic conditioning and treadmill training.
干预措施: Treadmill Training (Procedure)
结局指标
主要结局
Self Selected Walking Speed
时间窗: Change from baseline to 4 weeks.
We will measure how fast participants walk during the 10 meter walk test.
次要结局
- Knee Extensor Fatigability(Change from baseline to 4 weeks.)
- Knee Extensor Leg Strength(Change from baseline to 4 weeks.)
- Peak Oxygen Consumption(Change from baseline to 4 weeks.)
- Flow Mediated Dilation of Non-Paretic Brachial Artery and Paretic Popliteal Artery(Change from baseline to 4 weeks.)
研究者
Matthew J. Durand
Assistant Professor
Medical College of Wisconsin