Efficacy and Neurophysiological Correlates of a Bilateral Robotic Treatment for Patients With Chronic Stroke Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Changes in Fugl-Meyer for the Upper Limb (UEFM) scale pre vs post training
研究概览
简要总结
This study investigated the effectiveness and neurophysiological correlates of Bilateral Robot-Assisted Training (BRAT) in right-handed individuals with chronic unilateral stroke, focusing on how lesion side (dominant vs. non-dominant hemisphere) influences recovery. Twenty-four participants (>6 months post-stroke) completed a three-week BRAT program using the ALEx-RS robotic exoskeleton integrated with cognitively engaging serious games involving symmetric and asymmetric upper limb tasks.
Clinical outcomes (Fugl-Meyer Assessment, Bimanual Activity Test, Motricity Index) and kinematic measures (movement smoothness, movement duration) were assessed at baseline, post-treatment, and at two-month follow-up. Significant improvements (p < 0.05) in all outcomes were observed after training and maintained at follow-up.
Patients with left hemiparesis (non-dominant side affected) showed greater gains in movement smoothness and bimanual task quality, suggesting recovery of more physiological motor patterns. Conversely, those with right hemiparesis (dominant side affected) improved mainly in movement speed, indicating compensatory strategy use. Greater baseline impairment predicted larger kinematic gains, particularly in the left hemiparesis group.
These findings support BRAT as an effective intervention for chronic stroke and underscore the importance of lesion side in shaping recovery profiles, with implications for personalized rehabilitation planning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first-ever unilateral stroke event;
- •upper limb paresis with the ability to perform at least antigravity movements of the upper limb;
- •right- hand dominance.
排除标准
- •impossibility to provide informed consent;
- •cognitive impairment limiting the ability to understand the therapist's directions (screening Mini-Mental State Examination score <24/30);
- •hemispatial neglect, severe memory/attention impairment or severe aphasia;
- •degree of spasticity of the upper limb such as to make the use of robotic devices impossible (Modified Ashworth Scale score > 3).
研究组 & 干预措施
LHS
Left Hemisphere affected
干预措施: Robotic arm exoskeleton integrated with cognitively engaging serious games (Device)
RHS
Right Hemisphere affected
干预措施: Robotic arm exoskeleton integrated with cognitively engaging serious games (Device)
结局指标
主要结局
Changes in Fugl-Meyer for the Upper Limb (UEFM) scale pre vs post training
时间窗: From the pre-training evaluation (T0) to the post-training evaluation (T1), about 3 weeks after T0, to the follow up T2, about 2 months after T1
The Fugl-Meyer for the Upper Limb ranges from 0 to 66, with higher scores indicating better performance
Changes in Motricity Index (MI) scale pre vs post training
时间窗: From the pre-training evaluation (T0) to the post-training evaluation (T1), about 3 weeks after T0, to the follow up T2, about 2 months after T1
The Motricity Index ranges from 0 to 100, with higher scores indicating better performance
Changes in Bimanual Activity Test (BAT) scale pre vs post training
时间窗: From the pre-training evaluation (T0) to the post-training evaluation (T1), about 3 weeks after T0, to the follow up T2, about 2 months after T1
The Bimanual Activity Test ranges from 0 to 100, with higher scores indicating better performance
次要结局
- Changes in movement smoothness pre vs post training(From the pre-training evaluation (T0) to the post-training evaluation (T1), about 3 weeks after T0)
- Changes in movement duration pre vs post training(From the pre-training evaluation (T0) to the post-training evaluation (T1), about 3 weeks after T0)
研究者
Carmelo Chisari
Prof.
Azienda Ospedaliero, Universitaria Pisana