Cognitive Priming for Stroke Tele-rehabilitation
NCT Number: NCT06555302
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: BEHAVIORAL: Cognitive Rehabilitation|BEHAVIORAL: Occupational Therapy
Sponsor: Medical University of South Carolina
Collaborators: National Institute of General Medical Sciences (NIGMS)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-04
Locations: Medical University of South Carolina, Charleston, South Carolina, 29425, United States

Summary:
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.

Primary Outcome Measures: Change From Baseline Global Cognition, as Measured by the Montreal Cognitive Assessment (MoCA), 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/)., Baseline prior to treatment and at post-assessment within 10 days post-treatment|Change From Baseline Functional Task Performance and Activity Participation, as Measured by the Patient Specific Functional Scale (PSFS), 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., Baseline prior to treatment and at post-assessment within 10 days post-treatment|Change From Baseline Psychosocial Function (Depression), as Measured by the Patient Health Questionnaire (PHQ-9), 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., Baseline prior to treatment and at post-assessment within 10 days post-treatment
Secondary Outcome Measures: Change From Baseline Subjective Cognition, as Measured by the NeuroQoL-Cognitive Function, 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., Baseline prior to treatment and at post-assessment within 10 days post-treatment|Change From Baseline Functional Task Performance and Activity Participation, as Measured by the Performance Quality Rating Scale (PQRS), Performance Quality Rating Scale (PQRS) is a therapist-rated measure. The OT observes the participant's performance of a task and rates it on a 0-10-point ordinal scale with higher ratings indicating greater task performance skill., 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), 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., 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, Inventory of Psychosocial Functioning is an 80-item self-report measure of impairment in 7 psychosocial domains within the last 30 days: romantic relationships, family other than spouse/partner, 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 and multiplied by 100; an overall score is the average of domain scores; higher scores indicate greater impairment in psychosocial function., 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, 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., Baseline prior to treatment and at post-assessment within 10 days post-treatment