Proactive and Reactive Perturbation Training to Reduce Falls and Improve Gait Stability in People With Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Fall incidence
研究概览
简要总结
Following a stroke, many individuals have a high risk of falls, which can negatively influence quality of life. Unfortunately, current treatments have not effectively addressed this problem. This study investigates whether two methods of delivering mechanical perturbations during walking have the potential to improve post-stroke walking balance and reduce real-world fall incidence.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Experience of a stroke at least 6 months prior to participation
- •Self-reported experience of a fall in the previous year, and/or a fear of falling
- •Gait speed of at least 0.2 m/s
- •Ability to walk on a treadmill without a cane or walker
- •Provision of informed consent
排除标准
- •Evidence of cerebellar damage
- •Resting blood pressure higher than 220/110 mm Hg
- •History of unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
- •Preexisting neurological disorders or dementia
- •Legal blindness or severe visual impairment
- •History of DVT or pulmonary embolism within 6 months
- •Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
- •Orthopedic injuries or conditions (e.g. joint replacements) in the lower extremities with the potential to alter the gait pattern
研究组 & 干预措施
Reactive Perturbations
干预措施: Reactive Perturbations (Behavioral)
Proactive Perturbations
干预措施: Proactive Perturbations (Behavioral)
结局指标
主要结局
Fall incidence
时间窗: 32 weeks (12-week period pre-intervention; 12-week period post-intervention)
A fall will be defined as an event in which a participant loses their balance and comes to rest on the ground, floor, or lower level. Falls will be measured during the 12-week periods preceding and following the intervention, using 2-week calendars on postcards to be sent to the investigators.
次要结局
- Activities-specific Balance Confidence scale(8 weeks (pre-intervention; post-intervention))
- Foot placement stabilization strategy (gluteus medius activity)(8 weeks (pre-intervention; post-intervention))
- Walking speed(8 weeks (pre-intervention; post-intervention))
- Fear of falling(8 weeks (pre-intervention; post-intervention))
- Push-off stabilization strategy (mechanics)(8 weeks (pre-intervention; post-intervention))
- Push-off stabilization strategy (medial gastrocnemius activity)(8 weeks (pre-intervention; post-intervention))
- Functional Gait Assessment(8 weeks (pre-intervention; post-intervention))
- Center of pressure shift stabilization strategy (mechanics)(8 weeks (pre-intervention; post-intervention))
- Largest rejected perturbation (trained perturbations) Largest rejected perturbation (trunk)(8 weeks (pre-intervention; post-intervention))
- Largest rejected perturbation (untrained perturbations) Largest rejected perturbation (trunk)(8 weeks (pre-intervention; post-intervention))
- Foot placement stabilization strategy (mechanics)(8 weeks (pre-intervention; post-intervention))
- Center of pressure shift stabilization strategy (peroneus longus activity)(8 weeks (pre-intervention; post-intervention))
- Angular momentum modulation (trained perturbations) Largest rejected perturbation (trunk)(8 weeks (pre-intervention; post-intervention))
- Angular momentum modulation (untrained perturbations) Largest rejected perturbation (trunk)(8 weeks (pre-intervention; post-intervention))
研究者
Jesse Dean
Associate Professor
Medical University of South Carolina