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临床试验/NCT03792061
NCT03792061进行中(未招募)不适用

Adopting Strategy Training to Improve Participation Performance of Individuals With Cognitive Impairments After Stroke

Taipei Medical University4 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2019年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
210
试验地点
4
主要终点
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)

研究概览

简要总结

Abstract

Method: Participants with a diagnosis of stroke and have cognitive impairment (a score of 3 or more on the Executive Interview, 14-item version) will be randomly assigned to the intervention group and the attention control group at a 1:1 ratio. Each session will be around 45 minutes and will be delivered 1 to 2 sessions per week for 12 to 15 sessions.

Outcome measures including the Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D), Canadian Occupational Performance Measure(COPM), Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms, Wisconsin Card Sorting Task (WCST), Stroop Test, Montreal Cognitive Assessment (MoCA), Trail-Making Test (TMT A and B), The National Institutes of Health Stroke scale (NIHSS), modified Rankin Scale (MRS), Euro-QoL-5-Dimension (EQ-5D) and Participation Strategies Self Efficacy Scale (PS-SES) will be administered at baseline (T1), post-intervention (T2), 3-month follow-up (T3), 6-month follow-up (T4), and 12-month follow-up (T5).

Of the recruited participants, 50 will recieve the fMRI tests (including the resting-state scan, the fMRI scan with Stroop Test and TMT tasks, and the anatomical structure scan) at baseline, post-intervention, and 6month follow-up.Data will be analyzed using multiple linear regression models and mixed-effects regression models.

详细描述

The proposed study will examine the efficacy of a newly developed intervention program, the Optimizing Participation after Stroke through Strategy-training (OPASS) program on improving participation in productivity, social activities, and community among community-dwelling people with cognitive impairments after stroke. The OPASS program were developed based on the theoretical tenets of strategy training, with the goal of helping participants to set their participation goals, identify barriers to their performance, develop strategies to address these barriers, and generalize their learning through iterative practice. To examine the efficacy of OPASS, the following objectives will be addressed in this study:

  1. To examine whether, compared to a control group, participating in the OPASS program will improve participation in productivity, social, and community domains in stroke survivors with cognitive impairments;
  2. To determine whether the changes in participation after the intervention is correlated with changes in applied cognition, daily activities, executive functioning, and self-efficacy.
  3. To examine whether the intervention effect sustains at 3-, 6-, and 12-month following the intervention.

To address this purpose, parallel-group randomized controlled trial will be implemented to assess the efficacy of the OPASS program in comparison to the control group. An expected sample of 210 adults with stroke-related cognitive impairments and are undergoing outpatient rehabilitation services will be recruited from our collaborative sites in Northern Taiwan. These participants will be randomly assigned to the intervention group and the attention control group at a 1:1 ratio.

Outcome measures including the Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D), Canadian Occupational Performance Measure(COPM), Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms, Wisconsin Card Sorting Task (WCST), Stroop Test, Montreal Cognitive Assessment (MoCA), Trail-Making Test (TMT A and B), The National Institutes of Health Stroke scale (NIHSS), modified Rankin Scale (MRS), Euro-QoL-5-Dimension (EQ-5D) and Participation Strategies Self Efficacy Scale (PS-SES) will be administered at baseline (T1), post-intervention (T2), 3-month follow-up (T3), 6-month follow-up (T4), and 12-month follow-up (T5). Data will be analyzed using multiple linear regression models and mixed-effects regression models. Of the recruited participants, 100 will recieve the fMRI tests (including the resting-state scan, the fMRI scan with Stroop Test and TMT tasks, and the anatomical structure scan) at baseline(T1), post-intervention(T2), and 12-month follow-up (T5). Data will be analyzed using multiple linear regression models and mixed-effects regression models.

Qualitative in-depth interviews with participants, caregivers, and therapists will be conducted following the intervention. Data regarding the interviewees' experiences, satisfaction, and their perceived effectiveness of the intervention will be collected. Transcribed data will be coded by two independent coders and analyzed with thematic analysis method.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 20 years and older
  • Has a diagnosis of stroke
  • Understand Mandarin
  • Has cognitive impairment (a score of 3 or more on the Executive Interview, 14-item version)
  • Provide informed consent

排除标准

  • Have severe aphasia
  • Have a pre-stroke diagnosis of dementia, current major depressive disorder, substance use, or other psychiatric disorders that may impede them from continually participating in the study.

结局指标

主要结局

Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)

时间窗: From baseline to 6-8 weeks (post-intervention)

The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.

次要结局

  • Euro-QoL-5-Dimension (EQ-5D)(From baseline to 3-month, 6-month, and 12-month follow-ups)
  • Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)(From baseline to 12-month follow-up)
  • General self-efficacy Scale (GSES)(From baseline to 12-month follow-up)
  • Stroop Test(From baseline to 12-month follow-up)
  • modified Rankin Scale (MRS)(From baseline to 3-month, 6-month, and 12-month follow-ups)
  • Qualitative data(After intervention, an average of 2 months)
  • HEAL positive outlook questionnaire(From baseline to up to 6-8 weeks (post-intervention))
  • Canadian Occupational Performance Measure (COPM)(From the first session to the last session of the study, up to 8 weeks)
  • Montreal Cognitive Assessment (MoCA)(From baseline to 12-month follow-up)
  • The National Institutes of Health Stroke scale (NIHSS)(From baseline to 3-month, 6-month, and 12-month follow-ups)
  • Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms(From baseline to 12-month follow-up)
  • Trail-Making Test (TMT A and B)(From baseline to 12-month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Feng-Hang Chang

Associate Professor, Graduate Institute of Injury Prevention and Control, Taipei Medical University

Taipei Medical University

研究点 (4)

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