NCT07331896

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' attention and awareness of their neglect. This study seeks to examine the effects of strategy training on neglect, self-awareness, and disability, specifically for individuals who are living in the community after their stroke.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
32mo left

Started Apr 2026

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Jan 2029

First Submitted

Initial submission to the registry

December 26, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

April 6, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

2.7 years

First QC Date

December 26, 2025

Last Update Submit

April 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in attention/neglect

    Change in attention/neglect measured with the Catherine Bergego Scale. Total scores on the Catherine Bergego Scale therapist-rated assessment range from 0-30 (higher=greater neglect). The a priori criterion for change was a medium effect size of change (Cohen's d≥0.5)

    Baseline to Post-intervention (up to 60 days)

Secondary Outcomes (1)

  • Client Satisfaction with Strategy Training

    Post-intervention (up to 60 days)

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

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

Strategy Training

This intervention will use a reflective listening protocol.

Attention Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • had a stroke
  • presence of neglect as determined by score of \<18 or 2 or more collisions 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);
  • ≥18 years old
  • lives within 30 miles of the University of Pittsburgh in a community dwelling.

You may not qualify if:

  • Boston Diagnostic Aphasia Examination (BDAE) Severity Scale score of 0
  • dementia per medical record
  • active major depressive disorder per medical record
  • not willing to be videotaped
  • subject is currently receiving rehabilitation therapy as part of their usual care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

RECRUITING

MeSH Terms

Conditions

StrokePerceptual Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Emily Grattan, PhD, OTR/L

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Grattan, PhD, OTRlL

CONTACT

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

December 26, 2025

First Posted

January 12, 2026

Study Start

April 6, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

At present, there is no plan to share data.

Locations