NCT07061691招募中不适用
WIM Exosuit Wearable Soft Robot for Enhancing Walking Activity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 6-minute walk test
研究概览
简要总结
This study is to develop, test, and optimize a soft hip wearable robot for individuals who have experience a stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Be at least 6 months post-stroke, have a diagnosis of Parkinson's, have a diagnosis of multiple sclerosis, or an adult older than 65 with no known neurological diagnoses.
- •For the Optimization Aim of the study, Participants may also be healthy individuals with no known impairments.
- •Age: 18-89 years of age
- •For stroke, Parkinson's, multiple sclerosis, or older adult participants, must have adequate cognitive function (MMSE score >17)
- •Ability to walk at least 10 meters with maximum of 1 person assist
- •Able to safely fit into the WIM exosuit, which is confirmed via an in-person fitting..
排除标准
- •- <90 days post major orthopedic surgery (i.e. hip, knee, and/or ankle joint replacement.)
- •< 6 months post CABG or cardiac valve procedure
- •Any skin irritations / conditions that may preclude a participant from tolerating the use of the exosuit.
- •Severe osteoporosis, defined as osteoporosis that has been diagnosed and a participant's doctor has recommended pharmacologic treatment, or there is both a history of osteoporosis and a history of fractures.
- •Serious cardiac conditions, such as hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living.
- •Pregnancy
- •Uncontrolled hypertension (resting systolic blood pressure greater than or equal to 150, or resting diastolic pressure greater than or equal to 90.) If a participant demonstrates a BP greater than these values, then the participant will sit quietly for 5 mins, and then be re-checked. If the BP values remain over those thresholds, then the participant will be excluded. Individuals in such situations may return to be re-screened for participation after they follow up with their physician and the hypertension is better controlled.
- •Lower extremity fracture, either currently or within the past 6 months.
- •Modified Ashworth Spasticity (MAS) scores of ≥ 3 in hip flexors or extensors, if the participant is post-stroke or multiple sclerosis.
- •Pre-existing neurological disorders such as amyotrophic lateral sclerosis (ALS), dementia
- •History of major head trauma, lower extremity amputation, non-healing ulcers of a lower extremity, ongoing active infections, legal blindness, or a history of significant psychiatric illness.
结局指标
主要结局
6-minute walk test
时间窗: Baseline (Single-session)
Primary outcome for Optimization aim of study.
Metabolic Cost
时间窗: Baseline (single session)
Primary outcome for Optimization aim of study. Data collected using Cosmed K5 Metabolic Unit
次要结局
未报告次要终点
研究者
Arun Jayaraman, PT, PhD
Principal Investigator:Arun Jayaraman, PT, PhD,Shirley Ryan AbilityLab
Shirley Ryan AbilityLab
研究点 (2)
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