StrokeNCT06400147
Strategy Training for Individuals With Unilateral Neglect
A study testing Strategy Training in people with Stroke and Neglect, Hemispatial, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Neglect, Hemispatial
- What is being tested?
- Strategy Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2024to 25 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15219
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Neglect, Hemispatial
- Being tested
- Strategy Training, Attention Control
- Medical subject headings
- Stroke, Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strategy TrainingBehavioural
This intervention will use an adapted form of strategy training for people with neglect.
Attention ControlBehavioural
This intervention will use a reflective listening protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline to Post-intervention (up to 3 weeks)
Secondary outcomes (1)
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.
Measured: Post-intervention (up to 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start16 Aug 2024
- Primary completion25 Sep 2025
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Responsible party
- Principal investigator, Emily Grattan, University of Pittsburgh
- Investigators
- Emily Grattan, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400147
- Sponsor's protocol ID
- STUDY24030047
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Metacognitive Strategy Training for Individuals With Unilateral Spatial Neglect
- ClinicalTrials.gov ID
- NCT06400147
- Acronym / sponsor ID
- STUDY24030047
- Conditions
- Stroke, Neglect, Hemispatial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strategy Training | Experimental | Behavioral: Strategy TrainingThe 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. |
| Attention Control | Active comparator | Behavioral: Attention ControlThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strategy TrainingThis intervention will use an adapted form of strategy training for people with neglect. | Behavioural | Strategy Training |
| Attention ControlThis intervention will use a reflective listening protocol. | Behavioural | Attention Control |
Primary outcome
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)
1 secondary outcome
Client Satisfaction with Strategy Training
Time frame: Post-intervention (up to 3 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Grattan, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strategy Training in people with Stroke and Neglect, Hemispatial, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in online self-awareness (time frame: Baseline to Post-intervention (up to 3 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.