Cognitive Priming for Stroke Tele-rehabilitation

NCT06555302 | Completed DMC

• 2 other identifiers: Pro001363033P20GM109040-10S2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• Change From Baseline Global Cognition, as Measured by the Montreal Cognitive Assessment (MoCA)

  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/).

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

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

  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.

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

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

  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.

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

Secondary Outcomes (5)

• 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

• 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

Study Arms (1)

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.

Behavioral: Cognitive Rehabilitation; Behavioral: Occupational Therapy

Interventions

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).

Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation)

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.

Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Have moderate-severe or severe aphasia.
• Have impaired decision making capacity as determined by a standard protocol for assessing capacity to provide informed consent.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Cognitive Training; Occupational Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor-Faculty

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 15, 2024
• Study Start: August 20, 2024
• Primary Completion: April 9, 2025
• Study Completion: April 9, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)