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Strategy Training for Individuals With Unilateral Neglect

NCT ID: NCT06400147

Last Updated: 2025-12-30

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

RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-16

Study Completion Date

2026-02-15

Brief Summary

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It is common for individuals after stroke to have a cognitive perceptual impairment called unilateral spatial neglect (neglect). Individuals with neglect have difficulty paying attention to one side of their body or one side of the environment and therefore experience difficulty performing daily activities. There are a lack of effective treatments for neglect and new interventions are needed to help reduce disability for these individuals. Metacognitive strategy training (strategy training) is an intervention that has the potential to reduce neglect-related disability and improve individuals' awareness of their neglect. This study seeks to examine the effects of strategy training on self-awareness, disability, and neglect.

Detailed Description

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Unilateral spatial neglect (neglect) post stroke is characterized by a lack of attention to one side of the body or one side of the environment. Individuals with neglect experience significant disability and are often unaware of their neglect symptoms which can make it even more difficult to treat. There are a lack of effective treatments for neglect and new interventions are needed to help reduce disability for these individuals. Metacognitive strategy training (strategy training) is an intervention that has the potential to reduce neglect-related disability and improve individuals' awareness of their neglect. Strategy training teaches individuals to develop personalized goals, self-assess their performance of daily activities, and develop and evaluate strategies designed to overcome barriers and improve their performance of daily activities. While strategy training shows promise for individuals with neglect, no studies have tailored the intervention for this group of individuals or examined the effects of strategy training for individuals with neglect. This study examines whether strategy training facilitates reductions in disability and neglect and improves self-awareness after acute stroke.

Conditions

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Stroke Neglect, Hemispatial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Strategy Training

The strategy training intervention teaches individuals to develop personalized goals, self-assess their performance of daily activities, and develop and evaluate strategies designed to overcome barriers and improve their performance of daily activities. Participants use a workbook to support their application of the strategy training.

Group Type EXPERIMENTAL

Strategy Training

Intervention Type BEHAVIORAL

This intervention will use an adapted form of strategy training for people with neglect.

Attention Control

The attention control intervention controls for the non-specific effects of strategy training. The study team will administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.

Group Type ACTIVE_COMPARATOR

Attention Control

Intervention Type BEHAVIORAL

This intervention will use a reflective listening protocol.

Interventions

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Strategy Training

This intervention will use an adapted form of strategy training for people with neglect.

Intervention Type BEHAVIORAL

Attention Control

This intervention will use a reflective listening protocol.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* primary diagnosis of stroke
* admission to inpatient rehabilitation facility
* ≥18 years old
* presence of neglect as determined by score of \<18 on the Virtual Reality Lateralized Attention Test (VRLAT) or score below established cutoff for neglect on one of the six subtests of the Behavioral Inattention Test (BIT)

Exclusion Criteria

* Boston Diagnostic Aphasia Examination (BDAE) Severity Scale score of 0 (severe global aphasia)
* diagnosis of dementia indicated in medical record
* diagnosis of active major depressive disorder/bipolar/psychotic disorder indicated in medical record
* anticipated length of stay \<10 days
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Occupational Therapy Foundation

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Emily Grattan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emily Grattan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Emily Grattan, PhD

Role: CONTACT

Phone: 412-648-0619

Email: [email protected]

Facility Contacts

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Emily S Grattan

Role: primary

Other Identifiers

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STUDY24030047

Identifier Type: -

Identifier Source: org_study_id