Brain and Behavior Correlates of Arm Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change in Wolf Motor Function test
研究概览
简要总结
This project is designed to use three-dimensional movement analysis and magnetic resonance (fMRI) neuroimaging techniques to examine the brain activity and motor behavior changes associated with constraint-induced (CI) therapy for patients with sub-acute stroke (3-9 months post-stroke).Participants are evaluated at 5 time points-1-mo (pre & post), 6-mo (pre & post), and 12-mo. Each person is randomized to receive CI therapy either between pre- and post-evaluations or after the 6-mo pre-evaluation. We will determine the effects of CI therapy on 1) reaching and grasping actions using behavioral kinematics and 2) the sensorimotor network through fMRI scans with goal-directed aiming and grasping tasks. We will also determine the relationship between lesion size and location using 3-D volumetric MRI scans and behavioral outcomes as a consequence of CI therapy.
详细描述
PURPOSE OF THE STUDY AND BACKGROUND
- Specific Aims and Purpose of The Study: Overall, this proposal is to use three-dimensional movement analysis and magnetic resonance (fMRI) neuroimaging techniques to examine the brain activity and motor behavior changes associated with constraint-induced (CI) therapy for patients with sub-acute stroke. This project is a companion study to the recently funded multi-center randomized clinical trial (HD37606-01), Extremity Constraint-Induced Therapy Evaluation (EXCITE). This project complements EXCITE by probing the mechanisms underlying the clinical intervention in stroke rehabilitation. However, since enrollment for EXCITE has been completed, we will be enrolling a new set of participants.
A. SPECIFIC AIMS:
- Determine the relationship between lesion size and location as assessed using 3-D volumetric MRI and functional outcome (i.e, motor control and functional use) as a consequence of CI therapy.
- Determine the effects of CI therapy on the control of reaching and grasping actions as assessed using behavioral kinematics.
- Determine the effects of CI therapy on the neural substrate (sensorimotor network) as assessed using fMRI during goal-directed aiming and grasping tasks (performed as activation tasks in the scanner).
- Determine the persistence and or stability of these changes in, motor control, neural substrate, and functional use of the upper extremity in stroke with CI therapy 6 months later.
A.1: Specific working hypotheses for each aim are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
Evaluator was blinded to group membership
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
- •3 - 9 months post first-time stroke of infarct hemorrhagic type at the beginning of participation.
- •over the age of 18 years with no upper age limit.
- •cleared by a medical physician to participate.
- •Independent in basic activities of living.
- •minimum motor criteria: at least 10 degrees of active wrist extension, 10 degrees of finger extension in at least two fingers and the thumb (abduction) and the elbow (90 degrees flexion and extension) and shoulder (45 degrees flexion and abduction motion criteria.
排除标准
- •score below 24 on the Folstein Mini-mental status exam (MMSE)
- •score greater than an average of 2.5 on the Motor Activity Log (MAL) amount scale
- •are concurrently participating in any experimental drug study
- •are concurrently participating in any formal physical rehabilitation or clinical trials
- •do not meet the minimum motor criteria or who do not meet the minimum balance criteria.
- •pre-menopausal woman who is pregnant
结局指标
主要结局
Change in Wolf Motor Function test
时间窗: Immediately post-intervention to 1 year follow-up
The primary outcome measure for BCAR and to which we will correlate our brain and behavior measures are the Wolf motor function test (Wolf et al., 2001) and the Motor Activity Log (a semi-structured interview) of arm use for 30 ADL in the home. These measures of arm use capture arm function in the laboratory and in the real world and have acceptable psychometric properties.
Change Motor activity log
时间窗: Immediately post-intervention to 6 months follow-up
The primary outcome measure for BCAR and to which we will correlate our brain and behavior measures are the Wolf motor function test (Wolf et al., 2001) and the Motor Activity Log (a semi-structured interview) of arm use for 30 ADL in the home. These measures of arm use capture arm function in the laboratory and in the real world and have acceptable psychometric properties.
次要结局
- Change in Laterality-Index(Baseline to Immediately post-intervention)
研究者
Carolee Winstein
Professor, Biokinesiology and Physical Therapy
University of Southern California