Cognitive Priming to Boost Stroke Tele-rehabilitation Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change From Baseline Functional Task Performance and Activity Participation, as Measured by the Patient Specific Functional Scale (PSFS)
研究概览
简要总结
The goal of this pilot study is to investigate whether adding cognitive rehabilitation to an existing occupational therapy (OT) stroke telerehabilitation program will improve stroke survivors' functioning. The main question it aims to answer is whether this intervention improves cognition, participation, upper extremity use in real-world activities, and mood/quality of life. Participants will be asked to engage in an 8-week stroke tele-rehabilitation program (13 sessions), which includes both cognitive rehabilitation and OT for arm/hand function, and complete assessments before and after the intervention.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have experienced ischemic or hemorrhagic stroke with resultant paresis of one arm/hand at least 30 days prior
- •Adults ages 21 years or older
- •Are able to speak and read English
- •Have corrected vision to be able to read text on a screen
- •Have a device on which a telerehabilitation visit can be conducted (i.e., phone, tablet, or laptop) and a Wi-Fi connection or cellular service
- •Able to participate in the study's assessment sessions as per the judgment of the licensed, experienced stroke telerehabilitation occupational therapist.
排除标准
- •Have moderate-severe or severe aphasia.
- •Have impaired decision making capacity as determined by a standard protocol for assessing capacity to provide informed consent.
研究组 & 干预措施
Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation)
A trained OT will deliver the 8-week stroke telerehabilitation program. There will be 13 total sessions with 2 sessions/week for the first 5 weeks and 1 session/week for the last 3 weeks. The cognitive rehabilitation and OT components will be titrated as follows:
- Sessions 1-4 will focus on cognitive rehab.
- Sessions 5-10 will review/provide additional cognitive rehab and deliver OT.
- Sessions 11-13 may briefly review cognitive rehab but focus primarily on OT.
干预措施: Cognitive Rehabilitation (Behavioral)
Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation)
A trained OT will deliver the 8-week stroke telerehabilitation program. There will be 13 total sessions with 2 sessions/week for the first 5 weeks and 1 session/week for the last 3 weeks. The cognitive rehabilitation and OT components will be titrated as follows:
- Sessions 1-4 will focus on cognitive rehab.
- Sessions 5-10 will review/provide additional cognitive rehab and deliver OT.
- Sessions 11-13 may briefly review cognitive rehab but focus primarily on OT.
干预措施: Occupational Therapy (Behavioral)
结局指标
主要结局
Change From Baseline Functional Task Performance and Activity Participation, as Measured by the Patient Specific Functional Scale (PSFS)
时间窗: Baseline prior to treatment and at post-assessment within 10 days post-treatment
Patient Specific Functional Scale (PSFS) is a patient-reported measure of task-goal identification and difficulty performing the task on a 0-10-point ordinal scale with higher ratings indicating greater satisfaction with task performance.
Change From Baseline Global Cognition, as Measured by the Montreal Cognitive Assessment (MoCA)
时间窗: Baseline prior to treatment and at post-assessment within 10 days post-treatment
Montreal Cognitive Assessment (MoCA) is a 16-item objective cognitive screening measure. The maximum possible score = 30 points with higher scores indicating better cognition. Any necessary modifications for remote administration will be made according to guidelines provided on the official MoCA website (https://mocacognition.com/remote-moca-testing/).
Change From Baseline Psychosocial Function (Depression), as Measured by the Patient Health Questionnaire (PHQ-9)
时间窗: Baseline prior to treatment and at post-assessment within 10 days post-treatment
Patient Health Questionnaire (PHQ-9) is a 9-item self-report measure of depression. Items query mood (feeling down, lack of interest), thoughts (guilt, suicidality), and physical symptoms (appetite, sleep, fatigue, concentration, restlessness). Each item is scored on a 4-point scale reflecting how often the symptom has occurred over the last 2 weeks (0=not at all, 3=nearly every day). Scores are summed (out of 27), with higher scores indicating more symptoms of depression.
次要结局
- Change From Baseline Functional Task Performance and Activity Participation, as Measured by the Performance Quality Rating Scale (PQRS)(From intervention session #5 to intervention session #13 (5 weeks))
- Change From Baseline Functional Task Performance and Activity Participation, as Measured by the Stroke Self Efficacy Questionnaire (SSEQ)(Baseline prior to treatment and at post-assessment within 10 days post-treatment)
- Change From Baseline Psychosocial Function (Global), as Measured by the Inventory of Psychosocial Functioning(Baseline prior to treatment and at post-assessment within 10 days post-treatment)
- Change From Baseline Psychosocial Function (Sleep), as Measured by the PROMIS Sleep Disturbance(Baseline prior to treatment and at post-assessment within 10 days post-treatment)
- Change From Baseline Subjective Cognition, as Measured by the NeuroQoL-Cognitive Function(Baseline prior to treatment and at post-assessment within 10 days post-treatment)
研究者
Stephanie Aghamoosa
Assistant Professor-Faculty
Medical University of South Carolina