StrokeNCT06555302
Cognitive Priming for Stroke Tele-rehabilitation
A study testing Cognitive Rehabilitation and Occupational Therapy in people with Stroke, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Cognitive Rehabilitation and Occupational Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2024to 9 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Have moderate-severe or severe aphasia.
- Have impaired decision making capacity as determined by a standard protocol for assessing capacity to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Cognitive Priming to Boost Stroke Tele-rehabilitation Outcomes
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.
- Conditions
- Stroke
- Being tested
- Cognitive Rehabilitation, Occupational Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive RehabilitationBehavioural
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).
Occupational TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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:
* 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. Receives: Behavioral: Cognitive Rehabilitation; Behavioral: Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start20 Aug 2024
- Primary completion9 Apr 2025
- Study completion9 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Stephanie Aghamoosa, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555302
- Sponsor's protocol ID
- Pro00136303
- Other IDs
- 3P20GM109040-10S2
- Status last verified
- May 2026
- First submitted
- 12 Aug 2024
- Last updated
- 3 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Priming to Boost Stroke Tele-rehabilitation Outcomes
- ClinicalTrials.gov ID
- NCT06555302
- Acronym / sponsor ID
- Pro00136303
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 9 Apr 2025 (actual)
- Study completion
- 9 Apr 2025 (actual)
- First posted
- 15 Aug 2024 (actual)
- Results
- Posted 14 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation) | Experimental | Behavioral: Cognitive Rehabilitation, Behavioral: Occupational TherapyA 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Have moderate-severe or severe aphasia.
- Have impaired decision making capacity as determined by a standard protocol for assessing capacity to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive RehabilitationCognitive 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). | Behavioural | Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation) |
| Occupational TherapyOT 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. | Behavioural | Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation) |
Primary outcome
Change From Baseline in Global Cognition, as Measured by the Montreal Cognitive Assessment (MoCA)
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.
Change From Baseline Functional Task Performance and Activity Participation, as Measured by the Patient Specific Functional Scale (PSFS)
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.
Change From Baseline Psychosocial Function (Depression), as Measured by the Patient Health Questionnaire (PHQ-9)
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.
5 secondary outcomes
Change From Baseline Subjective Cognition, as Measured by the NeuroQoL-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)
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)
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)
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
Time frame: From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Rehabilitation and Occupational Therapy in people with Stroke, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Global Cognition, as Measured by the Montreal Cognitive Assessment (MoCA) (time frame: From pre-treatment assessment to post-treatment assessment, up to approximately 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.