Effects of NeuroReAlign Therapy on Cognition in Patients with Stroke: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
The goal of this randomized controlled trial is to investigate the effects of NeuroReAlign Therapy on cognition in stroke survivors in the chronic stage (>6 months). The study will include male and female participants aged 18-70 years.
The main questions it aims to answer are:
Does NeuroReAlign Therapy improve cognition in stroke survivors compared to conventional physiotherapy? Researchers will compare NeuroReAlign Therapy to conventional cognitive therapy to determine its effects on cognition.
Participants will:
Undergo NeuroReAlign Therapy or conventional cognitive therapy for 4 weeks. Have their cognition evaluated using the Montreal Cognitive Assessment (MoCA), Mini-Mental State Examination (MMSE), Trail Making Test (TMT), Stroop Test, Digit Span Test, and Verbal Fluency Test (VFT).
Complete outcome assessments at baseline and after the intervention (week 4).
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ischemic or hemorrhagic stroke
- •Have a stroke more than 6 months
- •Age between 18 and 70
排除标准
- •Patients with severe cognitive impairments
- •Patients cannot walk independently
研究组 & 干预措施
Conventional cognitive training
A conventional cognitive training protocol involves structured, repetitive exercises designed to enhance specific cognitive functions, such as memory, attention, executive function, and processing speed. These training programs are delivered through paper-and-pencil tasks, computer-based exercises, and therapist-guided activities. Tasks used include working memory exercises (e.g., digit span recall), attention training (e.g., Stroop test, visual scanning), problem-solving activities (e.g., Tower of Hanoi), and language exercises (e.g., verbal fluency tasks), for 45 minutes per session, 3 times weekly, for 4 weeks.
干预措施: Conventional cognitive training (Other)
NeuroReAlign Therapy
Patients in this group will receive NeuroReAlign Therapy, including motor training (e.g., treadmill training, balance training), multimodal sensory stimulation (e.g., proprioceptive and visual), cognitive training (e.g., traditional cognitive exercise), and motivation, for 45 minutes per session, 3 times weekly, for 4 weeks.
干预措施: NeuroReAlign Therapy (Other)
结局指标
主要结局
Montreal Cognitive Assessment (MoCA)
时间窗: At baseline (week 0) and post-intervention (week 4)
The Montreal Cognitive Assessment (MoCA) is a widely used screening tool designed to assess mild cognitive impairment in stroke survivors and other neurological populations. It evaluates multiple cognitive domains, including attention, memory, visuospatial abilities, executive function, language, and orientation. The test consists of 30 points, with a cutoff score of \<26 suggesting cognitive impairment. The MoCA is sensitive to subtle cognitive deficits and is particularly useful in detecting post-stroke cognitive impairments that may not be captured by other general cognitive tests.
次要结局
- Mini-Mental State Examination (MMSE)(At baseline (week 0) and post-intervention (week 4))
- Trail Making Test (TMT)(At baseline (week 0) and post-intervention (week 4))
- Stroop Test(At baseline (week 0) and post-intervention (week 4))
- Digit Span Test(At baseline (week 0) and post-intervention (week 4))
- Verbal Fluency Test (VFT)(At baseline (week 0) and post-intervention (week 4))
研究者
Anas Radi Hassan Alashram
Assistant Professor
Middle East University