Deconstructing Post Stroke Hemiparesis for Precision Neurorehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Arm Motor Assessment
研究概览
简要总结
TRACTs (DeconsTructing Post StRoke HemipAresis for PreCision NeurorehabiliTation) is a single timepoint study that aims to deconstruct post-stroke deficits of the upper extremity into distinct components and relate these components to brain anatomy and physiology.
详细描述
Veterans will be recruited through the Providence Veterans Affairs Medical Center and will have research visits at the Providence VA Center for Neurorestoration and Neurotechnology (CfNN, centerforneuro.org). The research visits will span two to three days. The study will involve motor outcome measures, magnetic resonance imaging of the brain, and transcranial magnetic stimulation. The goal of this study is to associate post-stroke deficits of the upper extremity with brain anatomy and physiology.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a unilateral ischemic stroke occurring >6 months prior as documented in medical chart
- •Upper extremity motor impairment as measured by Fugl-Meyer Upper Extremity Assessment ≤60
- •Ability to follow simple instructions in English
排除标准
- •Greater than moderate difficulty using the arm and hand pre-dating the stroke as assessed by the questions adapted from the QuickDASH outcome measure score on any question >= 3, which measures physical function and symptoms in people with difficulty using the arm and hand.
- •Visual or auditory disorders resulting in the inability to see or hear, respectively, the stimuli presented as part of research sessions
- •Inability to maintain a seated position for at least one hour
- •Standard MRI exclusion (e.g., significant claustrophobia or inability to tolerate loud noises, cardiac pacemaker (unless MRI-safe), implanted device (deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord)
- •Standard (single-pulse) TMS exclusion which include (in addition to those listed for MRI) pregnancy/lactation/planning to become pregnant during the study, seizure disorder, and primary or secondary CNS tumors
结局指标
主要结局
Fugl-Meyer Arm Motor Assessment
时间窗: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
This test provides information about the level of upper extremity motor impairment after stroke. It consists of a 33-item assessment, which provides a global assessment of upper extremity motor impairment. A rater observes 30 voluntary upper extremity motions, two tendon tap responses, and provides an ordinal rating (2 = near normal ability/response, 1 = partial ability, 0 = unable to perform/no response). The Fugl-Meyer Upper Extremity scale has excellent intra-rater reliability (0.99), inter-rater reliability (0.99), test-retest reliability (0.94-0.99), and internal consistency (0.97).
次要结局
- National Institute of Health Stroke Scale(Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent)
- History of TBI(Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent)
- Action Research Arm Test (ARAT)(Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent)
- Patient Health Questionnaire 9 (PHQ-9)(Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent)
- Edinburgh Handedness Inventory(Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent)
- Barthel Index(Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent)
- Modified Ashworth Scale(Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent)
- Nottingham Sensory Assessment (Erasmus MC)(Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent)
- Montreal Cognitive Assessment (MoCA)(Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent)
- Defense and Veterans Pain Rating Scale(Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent)
- Modified Rankin Scale(Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent)
- Manual Muscle Testing(Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent)
研究者
David Lin
Neurologist, Core Investigator
Providence VA Medical Center