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OpenTrials
Completed

NCT Number: NCT06400147

Strategy Training for Individuals With Unilateral 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Neglect, Hemispatial Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strategy Training

Behavioral

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

Attention Control

Behavioral

This intervention will use a reflective listening protocol.

Primary outcomes

  1. Change in online self-awareness

    Time frame: Baseline to Post-intervention (up to 3 weeks)

    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)

Secondary outcomes

  1. Client Satisfaction with Strategy Training

    Time frame: Post-intervention (up to 3 weeks)

    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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • American Occupational Therapy Foundation

Registry information

Official study title

Examining Metacognitive Strategy Training for Individuals With Unilateral Spatial Neglect

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 6, 2024
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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