Adopting Guided Training to Improve Participation Performance of Individuals With Cognitive Impairments After Stroke and Traumatic Brain Injury: A Feasibility Study (GTPCI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
研究概览
简要总结
Abstract
Objective: Investigators examined the feasibility of applying a participation-focused strategy training intervention to community-dwelling adults with cognitive impairments following stroke and brain injury and evaluated its potential effect on participation.
Method: Participants with a diagnosis of stroke or brain injury participated in this single-group, repeated-measures study. Participants received 1~2 sessions of strategy training intervention weekly for 8~18 sessions. Outcome measures included the Participation Measure--3 Domains, 4 Dimensions (PM-3D4D), the Canadian Occupational Performance Measure (COPM), and feasibility indicators (participants' recruitment, retention, attendance, engagement, comprehension, satisfaction, and intervention adherence).
详细描述
Method
Design A single-group, repeated-measures design was adopted for this study. All participants received the participation-focused strategy training intervention and the assessments at baseline (T1) and at post-intervention (T2). The study protocols were approved by the university institutional review board.
Intervention
The intervention protocols were developed based on the strategy training guidelines developed by Skidmore et al. Three trained research occupational therapists delivered the intervention to participants in addition to their regular outpatient rehabilitation care. The following standardized procedures were followed. First, the therapists asked the participants to identify three participation goals that they perceived important to them. Next, the participants were asked to identify barriers to their performance, and according to which the therapists taught the participants the "Goal-Plan-Do-Check" strategy, which involves (1) setting a goal to address the barriers, (2) developing a plan to address the goal, (3) doing the plan, and (4) checking if the plan worked or required revising. This procedure repeated iteratively until the participants' goal was met, and the next goal could be moved on to. At the end of each session, the therapists prompted the participants to identify the principles they learned during the session and encouraged the participants to apply these principles in the next session. Each participant received 1~2 intervention sessions per week for a total of 10~20 intervention sessions (or until their goals were achieved) from trained research therapists. Each session lasted for 45~60 minutes. All intervention sessions were recorded and rated for fidelity by research staff.
Measures
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria include that the participant:
- •ages 20 years and older;
- •had a first-time stroke or TBI;
- •is able to understand Mandarin;
- •has cognitive impairment (indicated by a score of 25 or less on the Montreal Cognitive Assessment (MoCA) or a score of 3 or less on the executive function subsection of MOCA);
- •is able to provide informed consent.
排除标准
- •Participants will be excluded if they:
- •have severe aphasia
- •have a pre-stroke diagnosis of dementia, current major depression disorder, substance use, or other psychiatric disorders that may impede them from continually participating in the study.
研究组 & 干预措施
Guided Training
干预措施: Guided Training (Behavioral)
结局指标
主要结局
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
时间窗: From baseline to 6 months following the completion of the intervention
The PM-3D4D is a 19-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community, rated on four dimensions: (1) 'Diversity of participation' (yes \[1\] vs. no \[0\]); (2) 'Frequency' (5- and 7-point scales, from "never" to "everyday or almost everyday"); (3) 'Desire for change' (yes \[1\] vs. no \[0\]); and (4) 'Perceived difficulty' (4-point scale, from "very difficult" \[1\] to "not difficult at all" \[4\]). Each dimensional score of the PM-3D4D can be separately summed for each domain. Psychometric properties of the PM-3D4D were established in rehabilitation populations.
Canadian Occupational Performance Measure (COPM)
时间窗: From the first session to the last session of the intervention, up to 10 weeks
The COPM inquires the client to identify important goals in their daily life and rate their performance and satisfaction for each goal on a 10-point visual analog scale.
次要结局
- Cognitive functioning(From baseline to 6 months following the completion of the intervention)
- Activities(From baseline to 6 months following the completion of the intervention)
研究者
Yen-Nung Lin
Director of Rehabilitation Department of Taipei Medical University WanFang Hospital
Taipei Medical University WanFang Hospital