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Completed

NCT Number: NCT06555302

Cognitive Priming for Stroke Tele-rehabilitation

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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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

    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.

  2. 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)

    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.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

Cognitive Priming to Boost Stroke Tele-rehabilitation Outcomes

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2024
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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