Strategy Training for Individuals With Unilateral Neglect

NCT06400147 | Completed

• 1 other identifier: STUDY24030047
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Neglect, Hemispatial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Client Satisfaction with Strategy Training

  Post-intervention (up to 3 weeks)

Study Arms (2)

Strategy Training

EXPERIMENTAL

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

Attention Control

ACTIVE COMPARATOR

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

Interventions

Strategy Training BEHAVIORAL

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

Strategy Training

Attention Control BEHAVIORAL

This intervention will use a reflective listening protocol.

Attention Control

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• American Occupational Therapy Foundation: collaborator
• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

MeSH Terms

Conditions

Stroke; Perceptual Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emily Grattan, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 6, 2024
• Study Start: August 16, 2024
• Primary Completion: September 25, 2025
• Study Completion: September 25, 2025
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)