Incline Training to Personalize Motor Control Interventions After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 4
- 主要终点
- Change in Gait Speed
研究概览
简要总结
This study will evaluate the use of incline and decline treadmill training to address specific motor control deficits identified within different post-stroke walking patterns.
详细描述
This study seeks to develop a theory-based clinical decision-making framework for the training of walking recovery after stroke based on how different biomechanical patterns of walking illustrate distinct motor control deficits. Each participant will complete 12 sessions (three times a week for four weeks) of either INCLINE, DECLINE, or CONTROL training. Clinical and biomechanical outcome measures will be collected pre- and post-training and after a one-month follow-up period. In addition, the investigators will collect a battery of clinical outcome measures before and after training. Spatiotemporal variables (including SSWS) will be collected before and after each session. All clinical and biomechanical assessments will be conducted by an evaluator blinded to training group allocation.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •stroke 6 months
- •residual paresis in the lower extremity (Fugl-Meyer LE motor score <34)
- •ability to walk without assistance at speeds ranging from 0.2 - 1.0 m/s (with a support harness for biomechanical testing)
- •Ability to walk on a treadmill without orthotic or assistive device using overhead harness system
- •provision of informed consent, and 8) written approval from the primary physician (see attached sample of Medical Approval Cover Letter).
排除标准
- •history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADLs
- •History of COPD or oxygen dependence
- •Pre-existing neurological disorders or dementia
- •History of major head trauma
- •Pp between 0.47 and 0.53
- •Legal blindness or severe visual impairment
- •Severe arthritis or other problems that limit passive ROM
- •History of DVT or pulmonary embolism within 6 months
- •Severe hypertension with systolic >200 mmHg and diastolic >110 mmHg at rest.
结局指标
主要结局
Change in Gait Speed
时间窗: Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart.
Participants will be asked to complete a 10 Meter Walk Test and a difference will be calculated between pre and post speed.
次要结局
- Change in Paretic Propulsion Symmetry(Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart.)