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Clinical Trials/NCT06555302
NCT06555302
Completed
Not Applicable

Cognitive Priming to Boost Stroke Tele-rehabilitation Outcomes

Medical University of South Carolina1 site in 1 country20 target enrollmentAugust 20, 2024
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Medical University of South Carolina
Enrollment
20
Locations
1
Primary Endpoint
Change From Baseline Functional Task Performance and Activity Participation, as Measured by the Patient Specific Functional Scale (PSFS)
Status
Completed
Last Updated
12 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 20, 2024
End Date
April 9, 2025
Last Updated
12 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stephanie Aghamoosa

Assistant Professor-Faculty

Medical University of South Carolina

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change From Baseline Functional Task Performance and Activity Participation, as Measured by the Patient Specific Functional Scale (PSFS)

Time Frame: Baseline prior to treatment and at post-assessment within 10 days post-treatment

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 Global Cognition, as Measured by the Montreal Cognitive Assessment (MoCA)

Time Frame: Baseline prior to treatment and at post-assessment within 10 days post-treatment

Montreal Cognitive Assessment (MoCA) is a 16-item objective cognitive screening measure. The maximum possible score = 30 points with higher scores indicating better cognition. Any necessary modifications for remote administration will be made according to guidelines provided on the official MoCA website (https://mocacognition.com/remote-moca-testing/).

Change From Baseline Psychosocial Function (Depression), as Measured by the Patient Health Questionnaire (PHQ-9)

Time Frame: Baseline prior to treatment and at post-assessment within 10 days post-treatment

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

  • 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 (5 weeks))
  • Change From Baseline Functional Task Performance and Activity Participation, as Measured by the Stroke Self Efficacy Questionnaire (SSEQ)(Baseline prior to treatment and at post-assessment within 10 days post-treatment)
  • Change From Baseline Psychosocial Function (Global), as Measured by the Inventory of Psychosocial Functioning(Baseline prior to treatment and at post-assessment within 10 days post-treatment)
  • Change From Baseline Psychosocial Function (Sleep), as Measured by the PROMIS Sleep Disturbance(Baseline prior to treatment and at post-assessment within 10 days post-treatment)
  • Change From Baseline Subjective Cognition, as Measured by the NeuroQoL-Cognitive Function(Baseline prior to treatment and at post-assessment within 10 days post-treatment)

Study Sites (1)

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