NCT04689256终止不适用
Pilot Randomized Controlled Study of the Impact of MedRhythms' MR-010 in Acute Stroke
University of Massachusetts, Worcester2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2021年11月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Change in Gait Speed (m/s)
研究概览
简要总结
The purpose of this clinical pilot study is to evaluate the effects of the MR-010 on tolerability, biomechanics and walking speed in the acute stroke care setting in addition to its impact on length of stay.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be 18 years of age or older.
- •Must be able to read and speak English fluently.
- •Be within 24 hours from admission for confirmed stroke event.
- •Currently able to walk at a speed greater or equal to 0.4m/s, but less than 1.0m/s, as determined by a 10-meter walk test for comfortable walking speed (the average of three trials).
- •Demonstrates some level of asymmetry in gait.
- •Is expected to be discharged from the acute care setting requiring physical therapy per standard of care and participant has verbally committed to receiving at least one therapy session.
- •Able and willing to consent with proposed study schema (verbal commitment), including consent to participate in communication with the treating clinician (as needed) during the study period.
- •Score ≤1 on question 1b and a 0 on question 1c on the NIH Stroke Scale.
- •Able to safely participate in protocol-defined walking therapy sessions of 30-minute duration as determined by the Investigator.
排除标准
- •Participant unable or unwilling to provide informed consent.
- •Has a known history of neurologic (excluding stroke) injury.
- •Has severe aphasia and/or a speech/language disorder, limiting ability to express needs and comprehend instructions.
- •Has an external lower limb prosthetic ("artificial limb").
- •Has a hearing impairment.
- •Had orthopedic surgery in the last year.
- •Has co-morbidities that prevent participation in exercise (for example: musculoskeletal, cardiovascular, pulmonary and neurological - other than stroke).
- •Vulnerable populations as deemed inappropriate for study by site Principal Investigator.
结局指标
主要结局
Change in Gait Speed (m/s)
时间窗: 90 days
Change in gait speed (m/s) from baseline to study completion as measured by a 6 meter walking test.
Adherence to MR-010 Therapy Schedule
时间窗: 90 days
Adherence to the MR-010 therapy schedule is measured by the number of participants who completed scheduled sessions (3 times per week for 12 weeks)
次要结局
- Length of Stay(Duration of hospital stay, up to 14 days)
- Readmission to Hospital(90 days)
研究者
研究点 (2)
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