Cognitive Priming for Stroke Tele-rehabilitation

NCT ID: NCT06555302

Last Updated: 2025-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-20

Study Completion Date

2025-04-09

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cognitive Rehabilitation + Occupational Therapy (Telerehabilitation)

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.

Group Type EXPERIMENTAL

Cognitive Rehabilitation

Intervention Type 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

Intervention Type 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.

Interventions

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Cognitive Rehabilitation

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).

Intervention Type BEHAVIORAL

Occupational Therapy

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Stephanie Aghamoosa

Assistant Professor-Faculty

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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3P20GM109040-10S2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00136303

Identifier Type: -

Identifier Source: org_study_id

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