Impact of Manual Preference on Motor Deficits After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment for Upper Extremity (FMA-UE) Score
研究概览
简要总结
This prospective, single-center observational study evaluates whether handedness is associated with upper-limb motor recovery after a recent unilateral stroke. Adults admitted to the stroke unit with a confirmed unilateral stroke within 5 days are included if they do not object to participation. Upper-limb impairment is assessed early after stroke and at 6 months using standardized clinical scales. Handedness is determined by self-report, and the Edinburgh Handedness Inventory is administered when feasible. The main hypothesis is that left-handed participants may show better upper-limb motor recovery at 6 months than right-handed participants, potentially due to differences in brain motor network lateralization.
详细描述
Participants hospitalized in the stroke unit with a confirmed unilateral stroke are recruited consecutively. After eligibility verification and absence of objection, baseline data are collected within 5 days post-stroke. Baseline assessments include the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE), the Shoulder Abduction and Finger Extension (SAFE) score, and the National Institutes of Health Stroke Scale (NIHSS) score (post-acute treatment if thrombolysis or thrombectomy was performed). Handedness is recorded after the motor assessments to maintain assessor blinding regarding group membership; the Edinburgh Handedness Inventory is administered when cognitive status allows. A 6-month follow-up is performed during routine post-stroke consultation at the study site, with repeat FMA-UE and SAFE assessments. The primary analysis compares FMA-UE at 6 months between left-handed and right-handed participants among those with baseline FMA-UE less than 66, using propensity score matching (3:1 right-handed to left-handed) accounting for age, baseline motor deficit, lesion side relative to dominance (dominant vs non-dominant hemisphere), and stroke type (ischemic vs hemorrhagic).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Confirmed unilateral recent stroke (less than 5 days).
- •Age 18 years and older.
- •Participant or proxy does not object to participation
排除标准
- •Prior stroke with residual motor sequelae.
- •Pre-stroke upper-limb deficit.
- •Follow-up at 6 months not planned at Orléans.
- •Protected adult (guardianship/curatorship), person under legal protection, or deprived of liberty.
- •Pregnant or breastfeeding woman.
研究组 & 干预措施
Patients with confirmed unilateral recent stroke
干预措施: evaluation (Other)
结局指标
主要结局
Fugl-Meyer Assessment for Upper Extremity (FMA-UE) Score
时间窗: month 6
Upper-limb motor impairment measured using the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE) at 6 months post-stroke. Scores range from 0 to 66, with higher scores indicating less impairment. Primary analysis is performed among participants with baseline FMA-UE less than 66.
次要结局
- Mean Fugl-Meyer Assessment for Upper Extremity (FMA-UE) Score(Baseline)
- Proportion of Left-Handed Participants(Baseline)
- Mean National Institutes of Health Stroke Scale (NIHSS) Score(Baseline)
- Number of Participants With Upper-Limb Weakness(Baseline)
- Correlation Between Edinburgh Handedness Inventory Laterality Quotient and Baseline FMA-UE Score(Baseline)
- Mean Shoulder Abduction and Finger Extension (SAFE) Score(Month 6)