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| ID | Type | Description | Link |
|---|---|---|---|
| 3P20GM109040-10S2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation) | Experimental | 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Rehabilitation | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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).
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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:
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| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
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| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This includes only participants with both pre- and post-treatment data. | Posted | Mean | Standard Deviation | total score | From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks |
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From enrollment until post-treatment assessment at the end of the study (approximately 10 weeks).
In this study, other (i.e., non-serious) adverse events were defined as those that were 1) unexpected, 2) related or possibly related to study participation, AND 3) severe or more prevalent than expected, in accordance with our local Institutional Review Board (IRB).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elbow pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Spontaneously reported elbow pain; mild severity; possibly related to the OT portion of intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephanie Aghamoosa | Medical University of South Carolina | 843-792-2956 | fountast@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 7, 2024 | Mar 26, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 8, 2024 | Apr 7, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| D009788 | Occupational Therapy |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Occupational Therapy | Behavioral | 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. |
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| 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. | 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. | 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. | 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. | From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Montreal Cognitive Assessment (MoCA) | The 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. | Mean | Standard Deviation | score on scale |
|
| 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. | Mean | Standard Deviation | score on scale |
|
| 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 (range: 0-27), with higher scores indicating more symptoms of depression. | Mean | Standard Deviation | score on scale |
|
| 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. | Mean | Standard Deviation | t-score |
|
| 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. | Mean | Standard Deviation | score on scale |
|
| 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 (total range from 0-130), with higher scores indicating greater self-efficacy. | Mean | Standard Deviation | score on scale |
|
| 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. | Mean | Standard Deviation | score on scale |
|
| 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. | Mean | Standard Deviation | t-score |
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| Primary | 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. | This includes only participants with both pre- and post-treatment data. | Posted | Mean | Standard Deviation | score on scale | From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks |
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| Primary | 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. | This includes only participants with both pre- and post-treatment data. | Posted | Mean | Standard Deviation | score on scale | From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks |
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| Secondary | 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. | This includes only participants with both pre- and post-treatment data. | Posted | Mean | Standard Deviation | t-score | From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks |
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| Secondary | 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. | This includes only participants with both pre- and post-treatment data. | Posted | Mean | Standard Deviation | score on scale | From intervention session #5 to intervention session #13 (approximately 5 weeks) |
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| Secondary | 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. | This includes only participants with both pre- and post-treatment data. | Posted | Mean | Standard Deviation | score on scale | From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks |
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| Secondary | 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. | This includes only participants with both pre- and post-treatment data. | Posted | Mean | Standard Deviation | score on scale | From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks |
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| Secondary | 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. | This includes only participants with both pre- and post-treatment data. | Posted | Mean | Standard Deviation | t-score | From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks |
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| 0 |
| 20 |
| 0 |
| 20 |
| 6 |
| 20 |
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| Laceration | Injury, poisoning and procedural complications | Non-systematic Assessment | Spontaneously reported laceration of arm from falling object at home; mild severity; not related to the intervention. |
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| Dental procedure | Surgical and medical procedures | Non-systematic Assessment | Spontaneously reported having emergency dental procedure to replace lost crown; mild severity; now related to the intervention. |
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| Dizziness | General disorders | Non-systematic Assessment | Spontaneously reported episode of dizziness at home; mild severity; not related to the intervention. |
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| Bruise | Injury, poisoning and procedural complications | Non-systematic Assessment | Spontaneously reported bruise on foot from exercising; mild severity; not related to the intervention. |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |