Intensive Upper Extremity Training Program During the Early Subacute Phase After Stroke: A Feasibility Study
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Fugl-Meyer upper extremity assessment (FM-UE)
研究概览
简要总结
The study assesses the feasibility of a 4-week upper extremity training program emphasizing quality of movement practiced at high intensity and dosage applied during the early subacute phase after stroke.
详细描述
Participants will receive 120 minutes of upper extremity training X 5 days per week for 4 weeks in addition to their daily rehabilitative routine (total therapy time 40 hours in addition to daily routine treatments of approximately 60 hours). Each session will be staffed with a 1:1 PT/OT to patient ratio.
The aim of the program is to increase the time spent on tasks using customized game-based platforms that include highly immersive, challenging and rewarding virtual environments for upper limb training. The focus of these game-based platforms is to reduce upper extremity impairments through emphasizing the quality of movement execution.
In one platform, the participant controls virtual dolphin movements by moving his/her paretic upper limb. The game utilizes advanced artificial intelligence (AI) analysis of the video recordings in real-time. In case the participant needs arm weight support, the practice will perform the task with a mechanical wearable exoskeleton vest, EkssoUE (Ekso Bionics) that can provide support at different weight levels. Arm weight support will be titrated as the patient progresses through each session and will be reduced/removed if no significant compensatory strategies were used.
The second platform, the HandTutor system (MediTouch) consists of an ergonomic wearable glove and a dedicated software with games that allow practicing active wrist movements, grip control and finger individuation in a challenging and motivating environment. Participant progresses through simple to difficult games while adjusting the range of motion that is being practiced according to participant's abilities.
Training in both platforms will be conducted in sitting. Participant will continue with their regular rehabilitative routine that includes daily physical and occupational therapy sessions and speech therapy if needed as well as group work and gym.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years;
- •Ischemic or hemorrhagic stroke (hemispheric or brainstem) confirmed by CT or MRI;
- •First-ever stroke or previous stroke with no upper extremity weakness;
- •1 week ≤ Time after stroke onset ≤ 6 weeks;
- •Active shoulder flexion of at least 20◦ and partial wrist and/or finger active movement;
- •Ability to provide inform consent.
排除标准
- •A painful shoulder limiting an active forward reach;
- •Severe spasticity or non-neural loss of range of motion;
- •Cognitive or communication impairments as determined by the clinical team;
- •Unstable medical conditions.
研究组 & 干预措施
Device-assisted therapy ("Meditouch","MSQUARE")
40 hours of therapy with the the Hand Tutor (MediTouch) device and a wearable vest (MSQUARE) for arm rehabilitation
干预措施: upper extremity training program ("Meditouch","MSQUARE") (Device)
结局指标
主要结局
Fugl-Meyer upper extremity assessment (FM-UE)
时间窗: From baseline to day 3 post-training
Change in arm impairment, measured by FM-UE. Maximum score (Performs fully) =226 points Minimum score= 0 points
次要结局
- Action research arm test (ARAT)(From baseline to day 3 post-training)
- Stroke Impact Scale (SIS)(From baseline to day 3 post-training)
研究者
Dr. Oren Barzel
Director of the Orthopedic Rehabilitation Department
Sheba Medical Center