Outcomes and Health Economics of Stroke Using Rhythmic Auditory Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 234
- 试验地点
- 2
- 主要终点
- Number of walking sessions during 12-week intervention period
研究概览
简要总结
The purpose of this trial is to assess engagement, efficacy, durability, and impact on health care resource utilization of MR-001 in persons with chronic stroke who have a gait deficit after in-home/community use.
详细描述
This is a decentralized clinical trial designed to assess clinical outcomes and resulting healthcare resource utilization (HCRU) of MedRhythms' MR-001 device used by patients with chronic stroke in the home setting.
MR-001 is an autonomous neurorehabilitation system based on the principles of Rhythmic Auditory Stimulation intended to improve walking in adult chronic stroke patients. MR-001 is a prescription medical device intended for use at home. The user operates the device autonomously and the therapy progresses automatically once a user engages in a session.
The MR-001 system consists of two foot sensors that measure walking, a locked touchscreen device preloaded with a proprietary software application, a headset, and charging equipment. The electronic components are powered by lithium-ion rechargeable batteries.
The primary objective of this study is to assess engagement with MR-001 walking therapy in chronic stroke patients with a gait deficit in a real world setting. The primary endpoint will be measured by session completion over the 12 week intervention period. Secondary endpoints include assessing effect on walking endurance, durability of response, and reintroduction of the intervention, as well as effect on healthcare resource utilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Equal to or greater than 6 months post-stroke with gait impairment
- •Age >/= 18 - 85 years of age, inclusive
- •Understand and speak English
- •Must be able to ambulate without assistance from another person. Note: assistive devices are allowed. If a participant uses an assistive device at the time of enrollment, the device must be used for all walking sessions.
- •Willing to travel to a Velocity location to complete in-person gait assessments
- •Able to walk at a speed greater than or equal to 0.4 m/s as derived as an average of speed per minute from the 6MWT. Note: if a participant intends to use an assistive device throughout the intervention period, the assistive device must be used during the gait assessment.
- •Must have claims data available and consent to sharing.
排除标准
- •Hearing impairment with or without the use of hearing aids such that the participant cannot hear the rhythmic stimulation of the music
- •Pain that impairs walking ability
- •Unable to safely participate in walking sessions as determined by investigator
- •Requires more than one rest (seated or not) during the 6MWT
- •Significant comorbid medical or neurological conditions that could impact gait or prevent safe participation as determined by the Investigator. For example: condition that prevents participation in exercise, e.g., Parkinson's disease, cerebral palsy, multiple sclerosis, myasthenia gravis, muscular dystrophy, or spinal cord injury. Note: major surgery within the last 3 months is exclusionary.
- •People who are pregnant or become pregnant (due to expected gait pattern changes).
- •Lower limb prosthetic
- •More than 2 falls in the previous month
- •Non-reciprocal gait pattern. Note: Note: a non-reciprocal gait pattern is defined as a 3-point step pattern. Participants must have a 2-point step pattern to qualify. Asymmetry seen in gait is acceptable.
- •Treatment with a gait-based investigational intervention within the last 3 months.
- •Unable or unwilling to provide informed consent to participate
结局指标
主要结局
Number of walking sessions during 12-week intervention period
时间窗: 12 weeks
The purpose of this study is to assess engagement with MR-001 walking therapy in chronic stroke patients with a gait deficit in a real world setting. Engagement will be measured as number of walking sessions observed across the 12 week intervention period.
次要结局
- Patient Health Questionnaire-8 (PHQ-8)(12 weeks)
- 6 Minute Walk Test (6MWT)(At 16 and 24 weeks)
- The Barthel Index(12 weeks)
- PROMIS Social Isolation Scale(12 weeks)
- Trail Making Tests A & B(12 weeks)