An interventional study of Cognitive Rehabilitation and Occupational Therapy in Stroke, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Cognitive Rehabilitation · Behavioral: Occupational Therapy
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.
Change From Baseline in Global Cognition, as Measured by the Montreal Cognitive Assessment (MoCA)
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
Change From Baseline Functional Task Performance and Activity Participation, as Measured by the Patient Specific Functional Scale (PSFS)
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
Change From Baseline Psychosocial Function (Depression), as Measured by the Patient Health Questionnaire (PHQ-9)
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
Change From Baseline Subjective Cognition, as Measured by the NeuroQoL-Cognitive Function
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 pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks
Change From Baseline Functional Task Performance and Activity Participation, as Measured by the Performance Quality Rating Scale (PQRS)
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 intervention session #5 to intervention session #13 (approximately 5 weeks)
Change From Baseline Functional Task Performance and Activity Participation, as Measured by the Stroke Self Efficacy Questionnaire (SSEQ)
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
Change From Baseline Psychosocial Function (Global), as Measured by the Inventory of Psychosocial Functioning (IPF)
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
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.
Time frame: From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks
Participants were recruited from the MUSC Stroke Recovery Research Center's Registry for Stroke Recovery (RESTORE). They were recruited between 8/7/2024 and 2/12/2025. The first participant was enrolled on 8/20/2024 and the last participant was enrolled on 2/12/2025.
| Milestone | Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation) |
|---|---|
| Started | 20 |
| Completed | 19 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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.
| total score | Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation) |
|---|---|
| Change From Baseline in Global Cognition, as Measured by the Montreal Cognitive Assessment (MoCA) | 1.74 ± 2.73 |
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.
| score on scale | Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation) |
|---|---|
| Change From Baseline Functional Task Performance and Activity Participation, as Measured by the Patient Specific Functional Scale (PSFS) | 2.84 ± 2.05 |
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.
| score on scale | Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation) |
|---|---|
| Change From Baseline Psychosocial Function (Depression), as Measured by the Patient Health Questionnaire (PHQ-9) | -0.26 ± 5.61 |
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.
| t-score | Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation) |
|---|---|
| Change From Baseline Subjective Cognition, as Measured by the NeuroQoL-Cognitive Function | 0.78 ± 8.59 |
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.
| score on scale | Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation) |
|---|---|
| Change From Baseline Functional Task Performance and Activity Participation, as Measured by the Performance Quality Rating Scale (PQRS) | 0.53 ± 0.70 |
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.
| score on scale | Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation) |
|---|---|
| Change From Baseline Functional Task Performance and Activity Participation, as Measured by the Stroke Self Efficacy Questionnaire (SSEQ) | 6.79 ± 18.20 |
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.
| score on scale | Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation) |
|---|---|
| Change From Baseline Psychosocial Function (Global), as Measured by the Inventory of Psychosocial Functioning (IPF) | -1.32 ± 10.92 |
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.
| t-score | Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation) |
|---|---|
| Change From Baseline Psychosocial Function (Sleep), as Measured by the PROMIS Sleep Disturbance | -2.58 ± 11.98 |
Collected over From enrollment until post-treatment assessment at the end of the study (approximately 10 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation) | 0/20 (0%) | 0/20 (0%) | 6/20 (30%) |
| Event | Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation) |
|---|---|
| Elbow painMusculoskeletal and connective tissue disorders | 2/20 |
| LacerationInjury, poisoning and procedural complications | 1/20 |
| Dental procedureSurgical and medical procedures | 1/20 |
| DizzinessGeneral disorders | 1/20 |
| BruiseInjury, poisoning and procedural complications | 1/20 |
| Age, Continuous(years) | Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation) |
|---|---|
| Mean | 57.6 ± 12 |
| Sex: Female, Male(Participants) | Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation) |
|---|---|
| Female | 10 |
| Male | 10 |
| Race (NIH/OMB)(Participants) | Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 5 |
| White | 13 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Ethnicity (NIH/OMB)(Participants) | Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation) |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 19 |
| Unknown or Not Reported | 0 |
| Montreal Cognitive Assessment (MoCA)(score on scale) | Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation) |
|---|---|
| Mean | 23.7 ± 3.7 |
| Patient Specific Functional Scale (PSFS)(score on scale) | Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation) |
|---|---|
| Mean | 2.2 ± 1.6 |
| Patient Health Questionnaire (PHQ-9)(score on scale) | Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation) |
|---|---|
| Mean | 5.4 ± 4.9 |
| NeuroQoL-Cognitive Function(t-score) | Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation) |
|---|---|
| Mean | 46.6 ± 11.0 |
4 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified data will be shared in the NIH-funded Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH).
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Medical University of South Carolina