A Comparison Between Personalized and Adaptive Tablet-based Cognitive Training and Paper-and-pencil Cognitive Training: a Randomized Controlled Trial With Community Dwelling Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
This study aims to assess the efficacy of two cognitive training programs - one tablet-based (NeuroAIreh@b) and one in paper-and-pencil format (Task Generator) - in improving cognitive and noncognitive outcomes among community-dwelling stroke survivors.
This study will include a waiting-list control group to assess the impact of these interventions and provide further insights into their potential for stroke survivors.
详细描述
The investigators plan to conduct a multicentric clinical trial with 45 participants randomly assigned to one of three groups. The study will have three arms, with each group receiving one of the following interventions: table-based cognitive training (NeuroAIreh@b), paper-and-pencil cognitive training (Task Generator) or no intervention (waiting-list control group). The latter group will not receive intervention during the study but will be offered the opportunity to participate in one of the cognitive training programs after completing the study. Additionally, the investigators will assess participants at three different time points: before the intervention (pre-intervention), immediately after the intervention (post-intervention), and three months after the intervention (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)
盲法说明
Participants won't be aware of which group they are randomized to.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke diagnosis;
- •Maximum age: 75 years old;
- •Education: at least three years of formal education;
- •Relatively preserved language abilities (expressive and receptive language);
- •Residing in the community;
- •Availability to go to the hospital 2x/week;
- •Preserved visual and auditory acuity;
- •Physically able to operate the tablet and perform the paper-and-pencil training;
- •Motivation to participate.
排除标准
- •Diagnosis of concomitant neurological and/or psychiatric disorders;
- •Hemianopsia;
- •Unilateral neglect;
- •Aphasia syndromes.
结局指标
主要结局
Montreal Cognitive Assessment (MoCA)
时间窗: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months).
change from baseline to post-intervention, and baseline to follow-up, in the MoCA; Min score=0; Max score=30; Higher are indicative of a better performance;
Toulouse-Piéron Cancellation Test (TP)
时间窗: : baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months)
change from baseline to post-intervention, and baseline to follow-up, in the TP; Min and Max scores=dependent on participants' performance during 10 minutes. A higher work efficiency index is indicative of a better performance, while a higher dispersion index is indicative of a worse performance.
Auditory Verbal Learning Test (AVLT)
时间窗: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months)
Change from baseline to post-intervention, and baseline to follow-up, in the AVLT; Min score=0; Max score=varies across trials (5 immediate recall trials: 75 points; 1 delayed recall trial: 15 points; 1 delayed recognition task: 30 points). Higher scores are indicative of a better performance.
Rey-Complex Figure Test (ROCFT)
时间窗: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months)
Change from baseline to post-intervention, and baseline to follow-up, in the ROCFT; Min score=0; Max score=36. Higher scores on both the copy trial and 3-minutes immediate recall trial are indicative of a better performance.
Verbal Fluency Tests
时间窗: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months).
Change from baseline to post-intervention, and baseline to follow-up, in the verbal fluency tests; Min score=0; Max score=dependent on participants' performance during the 1-minute task. Higher scores on the verbal fluency tests are indicative of a better performance.
Symbol Search and Digit Symbol (WAIS-III)
时间窗: baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months)
change from baseline to post-intervention, and baseline to follow-up, in both the Symbol Search and the Digit Symbol (WAIS-III); Min score=0; Max score=Dependent on participants' performance during the 120 seconds tasks. Higher scores in both subtests are indicative of a better performance.
次要结局
- Subjective Memory Complaints Questionnaire (SMCQ)(baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months).)
- Adults and Older Adults Functional Assessment Inventory (IAFAI)(baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months).)
- Hospital Anxiety and Depression Scale (HADS)(baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months).)
- Motivation for Traumatic Brain Injury Rehabilitation Questionnaire (MOT-Q)(baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months).)
- Quality of Life after Brain Injury (QOLIBRI)(baseline (1 week before the beginning of the intervention), post-intervention (7 weeks), and follow-up (1-month and 3-months))
研究者
Sergi Bermúdez i Badia
Associate Professor at the University of Madeira and Senior Researcher at NOVA LINCS
Universidade da Madeira