Clinical trial NCT06555302: Cognitive Priming for Stroke Tele-rehabilitation
Official title: Cognitive Priming to Boost Stroke Tele-rehabilitation Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2024-08-15
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Baseline Global Cognition, as Measured by the Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline prior to treatment and at post-assessment within 10 days post-treatment
measure: Change From Baseline Functional Task Performance and Activity Participation, as Measured by the Patient Specific Functional Scale (PSFS)
timeFrame: Baseline prior to treatment and at post-assessment within 10 days post-treatment
measure: Change From Baseline Psychosocial Function (Depression), as Measured by the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline prior to treatment and at post-assessment within 10 days post-treatment
Secondary outcomes:
measure: Change From Baseline Subjective Cognition, as Measured by the NeuroQoL-Cognitive Function
timeFrame: Baseline prior to treatment and at post-assessment within 10 days post-treatment
measure: Change From Baseline Functional Task Performance and Activity Participation, as Measured by the Performance Quality Rating Scale (PQRS)
timeFrame: From intervention session #5 to intervention session #13 (5 weeks)
measure: Change From Baseline Functional Task Performance and Activity Participation, as Measured by the Stroke Self Efficacy Questionnaire (SSEQ)
timeFrame: Baseline prior to treatment and at post-assessment within 10 days post-treatment
measure: Change From Baseline Psychosocial Function (Global), as Measured by the Inventory of Psychosocial Functioning
timeFrame: Baseline prior to treatment and at post-assessment within 10 days post-treatment
measure: Change From Baseline Psychosocial Function (Sleep), as Measured by the PROMIS Sleep Disturbance
timeFrame: Baseline prior to treatment and at post-assessment within 10 days post-treatment
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: