The Effects of Repetitive Arm Training Combined With Functional Electrical Stimulation on Upper Extremity Motor Recovery in Sub-acute Stroke Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 4
- 主要终点
- Changes from baseline in Fugl-Meyer Upper Extremity (FM-UE)
研究概览
简要总结
Rehabilitation restores functions and reduces disabilities due to diseases sequelae. The relationship between intensity of rehabilitation and clinical outcomes, recently emphasized, has generated a great interest for technological high-intensity interventions. However, their effects compared to traditional interventions as well the involved biological mechanisms remain uncertain. The present Strategic Program aims to predict the treatment efficacy in specific rehabilitation profiles, to improve the use of "targeted" therapies and the individual management of patients affected by stroke and to transfer these findings into rehabilitative strategies.
详细描述
Primary endpoint: Fugl-Meyer Upper Extremity (FM-UE) Secondary endpoints: Box and Block Test (BBT), Modified Ashworth Scale (MAS); motor cortex excitability (TMS); Electromyography analysis of muscle activation patterns during upper extremity movements; measurements of cerebral perfusion (NIRS); circulating biomarkers (see Figure 3 and Table 1). Overall assessments will be performed pre-, mid-, post-treatment and at 6-months follow-up.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males and females, age 18 to 79 years
- •diagnosis of first, single unilateral ischemic stroke verified by brain imaging < 8 weeks
- •upper limb motor function defined by an FM-UE score > 11 and <55
排除标准
- •medical conditions likely to interfere with the ability to safely complete the study protocol
- •impaired cognitive functioning: score less than 24 on the Mini Mental Status Examination (MMSE)
- •severe upper-limb pain, referred as > 7 at Visual Analog Scale (VAS)
- •history of seizures or epilepsy
结局指标
主要结局
Changes from baseline in Fugl-Meyer Upper Extremity (FM-UE)
时间窗: 1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up.
Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66.
次要结局
- Wolf Motor Function Test (WMFT) Manual(1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up)
- Modified Ashworth Scale (MAS)for spasticity measure(1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up)
- Motor Activity Log (MAL)measures change in arm use during activities of daily living(1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up)
- Box and Block test(1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up)
- Analysis of muscle activation patterns during upper extremity movements(1) One week prior to treatment initiation 2) the week after the end of treatment 3) at 6 months follow-up)
- NIRS (Near Infrared Spectroscopy)(1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up)
- Functional Independence Measure (FIM)(1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up)
- Stroke Impact Scale 3.0 (SIS)(1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up)
- Motor cortex excitability (single pulse and paired pulse TMS)(1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up)
- Circulating Biomarkers(1) One week prior to treatment initiation 2) after 3 weeks 3) the week after the end of treatment 4) at 6 months follow-up)
研究者
Sofia Straudi, MD
MD
University Hospital of Ferrara