The Effect of Intensive Training on Recovery of Fingers Dexterity Following Stroke: Behavioral, Physiological and Anatomical Predictors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in Fugl-Meyer Assessment Score for Upper Extremity at the immediate post-intervention time
研究概览
简要总结
The investigators aim to test whether intensive training of finger individuation during the sensitive window of the subacute phases can lead to a clinically-meaningful recovery of dexterous movement in stroke patients.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First symptomatic ischemic or hemorrhagic stroke
- •Clinically evident upper-limb motor deficit
- •Understand the study aim, is able to cooperate with the task for the specified time
- •Clinically stable
排除标准
- •Other neurological or psychiatric illness which affects upper-limb motor function
- •An orthopedic or rheumatologic disease that affects the ability to undergo a robotic hand therapy.
- •Sensory problems that prevent the patient from reporting pain during the robotic hand therapy
- •Skin breakdown or wounds located in places where the hand contacts the robot.
- •Patients with C/I to TMS (history of seizures, the existence of cardiac pacer, VP shunt, spinal stimulator or any other hardware that may malfunction at the presence of strong magnetic fields) will no undergo TMS but may participate in the study
- •Participation in another interventional study for upper limb rehabilitation
结局指标
主要结局
Change in Fugl-Meyer Assessment Score for Upper Extremity at the immediate post-intervention time
时间窗: Change from Baseline Score at 1-3 days post-intervention
A Likert-scale that quantifies movement quality, sensation, range of motion and pain in the upper limb following stroke. Range: 0 - 66. Higher values correlate with better motor control.
Change in Fugl-Meyer Assessment Score for Upper Extermity at 3-month post-intervention
时间窗: Change from Baseline Score at 3 month post-intervention
A Likert-scale that quantifies movement quality, sensation, range of motion and pain in the upper limb following stroke. Range: 0 - 66. Higher values correlate with better motor control.
Change in Individuation Index at 1-month post-intervention
时间窗: Change from Baseline Score at 1-month post-intervention
The relationship between forces (in Newton) in the active vs. passive fingers during a set of isolated finger movements. Higher numbers correlate with better finger-joint individuation, thus better dexterity.
Change in Fugl-Meyer Assessment Score for Upper Extermity at 1-month post-intervention
时间窗: Change from Baseline Score at 1 month post-intervention
A Likert-scale that quantifies movement quality, sensation, range of motion and pain in the upper limb following stroke. Range: 0 - 66. Higher values correlate with better motor control.
Change in Individuation Index at 3-month post-intervention
时间窗: Change from Baseline Score at 3-month post-intervention
The relationship between forces (in Newton) in the active vs. passive fingers during a set of isolated finger movements. Higher numbers correlate with better finger-joint individuation, thus better dexterity.
Change in Individuation Index at the immediate post-intervention time
时间窗: Change from Baseline Score at 1-3 days post-intervention
The relationship between forces (in Newton) in the active vs. passive fingers during a set of isolated finger movements. Higher numbers correlate with better finger-joint individuation, thus better dexterity.
次要结局
- Arm Research Action Test (ARAT) Score at the immediate post-intervention time(Change from Baseline Score at 1-3 days post-intervention)
- Change in M1 MEP (motor evoked potentials) amplitude at immediate post-intervention time(Change from Baseline Score at 1-3 days post-intervention)
- Change in M1 MEP (motor evoked potentials) amplitude at 1-month post-intervention(Change from Baseline Score at 1-month post-intervention)
- Change in MEP (motor evoked potentials) amplitude at 3-months post-intervention(Change from Baseline Score at 3-months post-intervention)
- Arm Research Action Test (ARAT) Score at at 3-month post-intervention(Change from Baseline Score at 3-month post-intervention)
- Arm Research Action Test (ARAT) Score at at 1-month post-intervention(Change from Baseline Score at 1-month post-intervention)
- Change in extent of SICI (short-interval cortical inhibition) at the immediate post-intervention time(Change from Baseline Score at 1-3 days post-intervention)
- Change in extent of SICI (short-interval cortical inhibition) at 1-month post-intervention(Change from Baseline Score at 1-month post-intervention)
- Change in extent of SICI (short-interval cortical inhibition) at 3-months post-intervention(Change from Baseline Score at 3-months post-intervention)
研究者
Nachum Soroker, MD
Head of Research, Department of Neurological Rehabilitation
Loewenstein Hospital