Stroke
Conditions
Brief 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.
Interventions
BEHAVIORALCognitive Rehabilitation
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).
BEHAVIORALOccupational Therapy
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.
Sponsors
Medical University of South Carolina
National Institute of General Medical Sciences (NIGMS)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Have moderate-severe or severe aphasia. * Have impaired decision making capacity as determined by a standard protocol for assessing capacity to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Global Cognition, as Measured by the Montreal Cognitive Assessment (MoCA) | 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. |
| Change From Baseline Functional Task Performance and Activity Participation, as Measured by the Patient Specific Functional Scale (PSFS) | 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. |
| Change From Baseline Psychosocial Function (Depression), as Measured by the Patient Health Questionnaire (PHQ-9) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Subjective Cognition, as Measured by the NeuroQoL-Cognitive Function | 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. |
| 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 (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. |
| Change From Baseline Functional Task Performance and Activity Participation, as Measured by the Stroke Self Efficacy Questionnaire (SSEQ) | 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. |
| Change From Baseline Psychosocial Function (Global), as Measured by the Inventory of Psychosocial Functioning (IPF) | 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. |
| Change From Baseline Psychosocial Function (Sleep), as Measured by the PROMIS Sleep Disturbance | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Of the 37 participants assessed for eligibility, 2 did not meet inclusion criteria, 1 declined to participate, and 14 were excluded for other reasons. 20 participants were assigned to treatment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 57.6 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Inventory of Psychosocial Functioning (IPF) | 21.0 score on scale STANDARD_DEVIATION 11.1 |
| Montreal Cognitive Assessment (MoCA) | 23.7 score on scale STANDARD_DEVIATION 3.7 |
| NeuroQoL-Cognitive Function | 46.6 t-score STANDARD_DEVIATION 11 |
| Patient Health Questionnaire (PHQ-9) | 5.4 score on scale STANDARD_DEVIATION 4.9 |
| Patient Specific Functional Scale (PSFS) | 2.2 score on scale STANDARD_DEVIATION 1.6 |
| Performance Quality Rating Scale (PQRS) | 6.1 score on scale STANDARD_DEVIATION 2.7 |
| PROMIS Sleep Disturbance | 49.7 t-score STANDARD_DEVIATION 15.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
| Stroke Self Efficacy Questionnaire (SSEQ) | 94.8 score on scale STANDARD_DEVIATION 30.5 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 6 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
None listed