Development of Sensory Augmentation Methods to Improve Post-stroke Gait Stability
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Related or Serious Adverse Events
研究概览
简要总结
Many chronic stroke survivors have poor walking balance, contributing to an increased risk of falls and fear of falling. One factor contributing to these balance deficits is a reduced ability to place the feet appropriately when walking. This study investigates whether enhancing the sensory information available to chronic stroke survivors while they walk improves their foot placement accuracy and balance.
详细描述
The objective of this project is to test a method of providing real-time augmentation of hip proprioceptive feedback during post-stroke walking. The sensory information available to participants will be augmented by providing vibration of the hip abductor musculature that is scaled to the near-real-time mechanical state of their body. The central hypothesis is that augmented proprioception will improve participants' perception of their body's motion, thus increasing the mechanics-dependent modulation of foot placement, an important gait stabilization strategy. This clinical trial will establish the safety, feasibility, and efficacy of a rehabilitation intervention centered on repeated exposure to sensory augmentation during gait. Specifically, participants in the experimental group will complete training sessions twice a week for four weeks in which they receive sensory augmentation during ~30 minutes of treadmill walking. Participants in the activity-matched control group will perform the same task, except the hip vibration will be randomly delivered, not linked to the body's actual mechanical state. Changes in walking balance and foot placement accuracy will be quantified over the course of the intervention.
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, Care Provider, 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 6 months prior to participation
- •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 congestive heart failure, 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
结局指标
主要结局
Percentage of Participants With Related or Serious Adverse Events
时间窗: Cumulative over the course of the 4-week intervention
The investigators will monitor the safety of the intervention by quantifying the percentage of participants who experience an adverse event potentially related to the intervention (e.g. skin irritation; falls) or any serious adverse event (e.g. hospitalization; death). This information is gathered through participant self-report, or through communication with participant caregiver if necessary.
Number of Training Sessions Attended
时间窗: Cumulative over the course of the 4-week intervention
The investigators will assess participant adherence as the number of training sessions attended (out of a maximum possible number of 8).
Intervention Feasibility (Drop-out)
时间窗: 4-weeks
The investigators will assess participant drop-out as the number of participants who do not attend the final Assessment Session.
Change in Mechanics-dependent Adjustment of Paretic Foot Placement
时间窗: 4-weeks
The primary effectiveness measure will be the change in participants' gait stabilization strategy over the course of the 4-week intervention. This will be quantified as the partial correlation between paretic mediolateral foot placement and mediolateral pelvis displacement at the start of the step over a 2-minute period of walking. The investigators will calculate the change in this metric from the initial (Week 0) assessment session to the final (Week 4) assessment session.
次要结局
- Intervention Feasibility (Walking Time)(Cumulative over the course of the 4-week intervention)
- Change in Fear of Falling(4-weeks)
- Change in Functional Gait Assessment Score(4-weeks)
- Change in Activity-specific Balance Confidence Score(4-weeks)
- Change in Overground Self-selected Gait Speed(4-weeks)