Efficacy and Feasibility of Using the NeuroLife Sleeve System to Improve Hand Function in Stroke Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Action Research Arm Test (ARAT)
研究概览
简要总结
The goal of this feasibility study is to test the feasibility of providing task-oriented, intention-driven functional electrical stimulation (FES) using the novel NeuroLife FES Sleeve and NeuroLife electromyography (EMG) and FES Sleeve devices in chronic stroke survivors. The main questions it aims to answer are:
- Can these devices be used to administer task-oriented therapy with assistive stimulation at similar doses to current standards of care?
- How does therapy using these devices impact the upper limb function in a few chronic stroke survivors?
Participants will receive assistive electrical stimulation synchronized to their movement intention while practicing functional tasks with everyday objects over the course of 8 weeks.
详细描述
Battelle has developed the NeuroLife FES Sleeve and NeuroLife EMG-FES Sleeve devices, wearable sleeves that deliver non-invasive functional electrical stimulation (FES) paired with user intention. Participants in this study will use these devices while practicing functional tasks for about one hour at each session. FES will be applied through the forearm sleeve devices to assist with hand movements and grasps required by functional tasks simulating everyday activities such as turning a key or picking up a phone.
Sessions will be scheduled three days per week for 8 weeks total. Participants will complete clinical assessments at the beginning, midpoint and end of intervention as well as at follow-up sessions 2- and 10-weeks after the end of intervention to track upper limb function and impairment. Each session will last 1.5-2 hours, and participants will be compensated for their time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Males and females ≥18 years old
- •Diagnosis of stroke
- •Ability to provide appropriate consent to partake in the study
- •Ability to follow 3-step commands and deemed by an occupational therapist to have the capacity to complete required upper extremity movements
- •Ability to secure transportation to attend scheduled study sessions
- •Stroke-related hand impairment that interferes with ability to complete activities of daily living and is classified as Stage 1-6 on the hand subscale of the Chedoke McMaster Stroke Assessment
排除标准
- •Presence of any other clinically significant medical comorbidity for which, in the judgment of the Investigator, participation in the study would pose a safety risk to the subject
- •Currently participating in physical rehabilitation (e.g., occupational or physical therapy) for stroke-related upper limb impairment
- •Co-occurring neurological condition (e.g., Parkinson's disease, Multiple Sclerosis) or other neuromuscular disorder (e.g., Carpal Tunnel Syndrome, neuropathy) that, in the judgment of the Investigator, may influence study results
- •Individuals who are immunosuppressed, have conditions that typically result in becoming immunocompromised, taking chronic steroids, or currently receiving immunosuppressive therapy
- •Individuals having or requiring any of the following: implanted pacemaker, life supporting/sustaining equipment, or critical non-removable implantable electronic devices such as an insulin pump.
- •Persistent pain ≥ 7/10 in impaired upper extremity, as measured by Visual Analogue Scale
- •Individuals whose forearm is determined to be too small or too large to fit the electrode sleeve being investigated.
- •Individuals who are pregnant or plan to get pregnant during the course of the study.
结局指标
主要结局
Action Research Arm Test (ARAT)
时间窗: Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up)
The Action Research Arm Test (ARAT) will be used to track functional changes from the pre-intervention baseline. The ARAT is a common measure of upper extremity function after stroke ranging from 0 (maximal impairment) to 57 (no impairment).
Therapy Dose
时间窗: Week 0-18 (during the intervention and follow-up periods)
Therapy Dose was used to estimate the feasibility of the therapy. Therapy Dose will be computed as the average amount of time at each session the subject was engaged in intention-driven, task-oriented functional electrical stimulation therapy, excluding the time needed to set up the system.
次要结局
- Box and Block Test (BBT)(Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up))
- Motor Activity Log(Week 0-8 (during the intervention period))
- Fugl-Meyer Assessment-Upper Extremity (UEFM)(Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up))
- Nine-Hole Peg Test (NHPT)(Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up))