Strategy Training for Individuals With Unilateral Neglect

Examining Metacognitive Strategy Training for Individuals With Unilateral Spatial Neglect

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Neglect, Hemispatial
• Intervention / Treatment: Behavioral: Strategy Training; Behavioral: Attention Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Strategy Training; This intervention will use an adapted form of strategy training for people with neglect.
Active Comparator: 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.	Behavioral: Attention Control; This intervention will use a reflective listening protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in online self-awareness	Change in online self-awareness measured with the Catherine Bergego Scale. The Catherine Bergego Scale includes a therapist-rated assessment and client-rated (self) assessment. Total scores on the Catherine Bergego Scale therapist-rated assessment and client-rated (self) assessment each range from 0-30 (higher=greater neglect). The difference in client-rated total Catherine Bergego Scale scores and assessor-rated total Catherine Bergego Scale scores will be used as a measure of online self-awareness (smaller difference=better awareness). The a priori criterion for change was a medium effect size of change (Cohen's d≥0.5)	Baseline to Post-intervention (up to 3 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client Satisfaction with Strategy Training	Client satisfaction is measured using the Client Satisfaction Questionniare-8. The a priori criterion for satisfaction was: ≥90% of participants report mean satisfaction score ≥3 on the Client Satisfaction Questionnaire-8 items. Item scores on the Client Satisfaction Questionnaire-8 range from 0-4. Higher scores on the Client Satisfaction Questionnaire-8=greater satisfaction.	Post-intervention (up to 3 weeks)

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: American Occupational Therapy Foundation
• Investigators: Principal Investigator: Emily Grattan, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2024
• Primary Completion (Actual): September 25, 2025
• Study Completion (Actual): September 25, 2025

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurobehavioral Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stroke; Perceptual Disorders
• Other Study ID Numbers: STUDY24030047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No