Strategy Training for Individuals With Unilateral Neglect

Stroke Clinical Trial

Official title:

Examining Metacognitive Strategy Training for Individuals With Unilateral Spatial Neglect

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06400147
• Other study ID #: STUDY24030047
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2024
• Source: University of Pittsburgh
• Contact: Emily Grattan, PhD
• Phone: 412-648-0619
• Email: esg39[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: December 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neglect, Hemispatial
• Perceptual Disorders
• Stroke

Intervention

Behavioral:
• Strategy Training
This intervention will use an adapted form of strategy training for people with neglect.
• Attention Control
This intervention will use a reflective listening protocol.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	American Occupational Therapy Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)