Rehabilitation Strategies for Social Participation in Chronic Stroke Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Feasibility: Fidelity (for each group)
研究概览
简要总结
The goal of this clinical trial is to test a new rehabilitation program, combining acceptance and commitment therapy with strategy training (ACES), to help people resume social participation after stroke and live in the community.
Investigators will also compare the changes in social participation and psychological flexibility from baseline to follow-up at one-month after rehabilitation to see if participants who receive ACES report clinically meaningful improvements (Cohen's d=0.2 or greater) compared to the existing rehabilitation program using strategy training alone (START).
Participants will:
- complete testing to see if they are eligible for the study. If qualified, complete testing to understand how the stroke has affected their daily life
- be randomized to receive either ACES or START rehabilitation program for 10 sessions at their home
- repeat part of the tests at the end of the intervention and one month after
详细描述
In April 2025, the investigator changed the recruitment status because the first enrolled participant ended up being ineligible. The investigators also updated eligibility criteria and outcome measures to be consistent with the IRB protocol.
In June 2025, the investigator received notice of award from NIH and thus updated information to be consistent with the IRB protocol.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary diagnosis of chronic stroke, ≥6 months post onset,
- •≥18 years old,
- •community-dwelling (i.e., living in a residential setting in the community),
- •restrictions in social participation, indicated by Activity Card Sort (<80% of pre-stroke activities)
排除标准
- •progressive neurological diagnosis (e.g., dementia, Parkinson's disease, multiple sclerosis, or brain tumor) reported by participants or proxy,
- •inability to provide written informed consent,
- •severe aphasia (score 0 or 1 on the Boston Diagnostic Aphasia Examination 3rd Edition Severity Rating Scale),
- •currently undergoing stroke rehabilitation or mental health intervention (but participation in maintenance sessions, self-help groups, or couples therapy is permitted),
- •major depressive disorder, indicated by PRIME-MD, unless undergoing treatment for at least 4 weeks and are released to participate by their physician or counselor
- •bipolar or psychotic disorder, indicated by PRIME-MD, or
- •substance use disorder within 3 months, indicated by Mini-International Neuropsychiatric Interview
研究组 & 干预措施
ACES
干预措施: Strategy Training embedded with Acceptance and Commitment Therapy Principles (Behavioral)
START
干预措施: Strategy Training Only (Behavioral)
结局指标
主要结局
Feasibility: Fidelity (for each group)
时间窗: Baseline to Post-intervention up to 8 weeks
Fidelity is measured using Strategy Training (ST) and Acceptance and Commitment Therapy (ACT) fidelity tools. All intervention sessions will be video recorded and a random 20 percent will be rated by independent evaluators trained by the principal investigator. ST fidelity will be assessed with the 10-item fidelity tool with 8 or more items rated as adequate or excellent indicating adequate fidelity. ACES fidelity will be assessed with a 22-item tool generated from the 10-item ST and 12-item ACT fidelity tools, with 18 or more items rated as adequate or excellent indicating adequate fidelity. The a priori criterion for adequate fidelity was that equal or greater than 80 percent of intervention sessions are rated with equal or greater than 80 percent of adequate fidelity for each START and ACES intervention.
Feasibility: Satisfaction (for each group)
时间窗: Baseline to Post-intervention up to 8 weeks
Client satisfaction is measured using the Client Satisfaction Questionnaire. The Clients Satisfaction Questionnaire is an 8-item assessment of satisfaction with the intervention program, rated on a 4-point scale that ranges from 1 to 4 in each item. An average score will be computed for each participant. High scores indicate high satisfaction. The a priori criterion for satisfaction was equal or greater than 80 percent of the sample has mean Client Satisfaction Questionnaire score of equal or greater than 2.5.
Feasibility: Fidelity (for each group)
时间窗: Baseline to Post-intervention up to 8 weeks
Fidelity is measured using Strategy Training (ST) and Acceptance and Commitment Therapy (ACT) fidelity tools. All intervention sessions will be video recorded and a random 20 percent will be rated by independent evaluators trained by the principal investigator. ST fidelity will be assessed with the 10-item fidelity tool with 8 or more items rated as adequate or excellent indicating adequate fidelity. ACES fidelity will be assessed with a 22-item tool generated from the 10-item ST and 12-item ACT fidelity tools, with 18 or more items rated as adequate or excellent indicating adequate fidelity. The a priori criterion for adequate fidelity was that equal or greater than 80 percent of intervention sessions are rated with equal or greater than 80 percent of adequate fidelity for each START and ACES intervention.
Feasibility: Satisfaction (for each group)
时间窗: Baseline to Post-intervention up to 8 weeks
Client satisfaction is measured using the Client Satisfaction Questionnaire. The Clients Satisfaction Questionnaire is an 8-item assessment of satisfaction with the intervention program, rated on a 4-point scale that ranges from 1 to 4 in each item. An average score will be computed for each participant. High scores indicate high satisfaction. The a priori criterion for satisfaction was equal or greater than 80 percent of the sample has mean Client Satisfaction Questionnaire score of equal or greater than 2.5.
次要结局
- Changes in social participation: Difficulty to participate in social activities(Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks)
- Changes in social participation: Satisfaction with social participation(Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks)
- Changes in psychological flexibility(Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks)
- Changes in wellbeing(Baseline to 1- Month Post-intervention (Follow-up) up to 12 weeks)
研究者
Minmei Shih
Research Scientist
University of Pittsburgh