Medical University of South Carolina
Charleston, South Carolina, 29425, United States
NCT Number: NCT06555302
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.
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Notify Me21 year and older
All sexes
Interventional
Not applicable
Charleston, South Carolina, 29425, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cognitive rehabilitation will be OT-led, one-on-one sessions focused on teaching cognitive strategies and their application to a broad set of activities/settings. The goal is to facilitate cognitive skill learning and generalization, by applying the new cognitive strategies to the participant's performance of home-based and community-based activities (taught through the subsequent OT portion of the intervention).
OT upper extremity rehabilitation will have 2 components: task-practice and metacognitive strategy training. The task-practice involves a patient repetitively practicing stroke-impaired movement skills within the context of a functional task to promote recovery of the impaired skills. THE task practice sessions will be coached/guided by the therapist through a metacognitive strategy training process which is based on the Cognitive Orientation to Occupational Performance (CO-OP) approach aimed at enhancing self-management during home and community living tasks.
Time frame: From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks
Montreal Cognitive Assessment (MoCA) is a 16-item objective cognitive screening measure. Total scores range from 0-30 points, with higher scores indicating better cognition.
Time frame: From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks
The 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.
Time frame: From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks
The 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.
Time frame: From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks
The NeuroQoL-Cognitive Function Short Form v.2.0 is a 29-item subjective measure of cognitive function. This patient-reported outcome assesses perceived abilities in memory, attention, decision making, or in the application of such abilities to everyday tasks (e.g., planning, organizing, calculating, remembering, and learning) on a 5-item rating scale (1=cannot do to 5=no difficulty). The summed raw score is converted into a normed T-score (mean=50, SD=10). Higher T-scores reflect better perceived cognitive function.
Time frame: From intervention session #5 to intervention session #13 (approximately 5 weeks)
The Performance Quality Rating Scale (PQRS) is a therapist-rated measure. The OT observes the participant's performance of a specific task and rates it on a 0-10-point ordinal scale, with higher ratings indicating greater task performance skill.
Time frame: From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks
The Stroke Self Efficacy Questionnaire (SSEQ) is a 13-item self-report measure of confidence (0-10-point Likert scale with higher numbers indicating greater confidence) doing at-home tasks such as using both hands to eat food or prepare a meal for oneself. Item scores are summed and total range from 0-130, with higher scores indicating greater self-efficacy.
Time frame: From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks
The Inventory of Psychosocial Functioning (IPF) is an 80-item self-report measure of impairment in 7 psychosocial domains within the last 30 days: romantic relationships, family, work, friendships and socializing, parenting, education, and self-care. Participants rate the frequency of difficulty on each item on a 7-point scale (0=never, 6=always). Scores are averaged by domain (if ≥80% of items are complete) and multiplied by 100; an overall score (grand mean, range: 0-100) is the average of completed domain scores; higher scores indicate greater impairment in psychosocial function.
Time frame: From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks
PROMIS Sleep Disturbance is an 8-item self-report measure of perceived difficulties falling and/or staying asleep. Items are rated on a 5-point rating scale (1=no problem, 5=very much a problem). The summed raw score is converted into a normed T-score (mean=50, SD=10). Higher T-scores reflect more sleep disturbance.
Medical University of South Carolina
Other
Cognitive Priming to Boost Stroke Tele-rehabilitation Outcomes
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