StrokeNCT02935270
Examining Measurement of Behavioral Neglect Post Stroke
An observational study of Stroke and Hemispatial Neglect, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to examine measurement of unilateral neglect post stroke. Although a number of clinical assessments are used to measure neglect, it is unclear whether items from some of the most commonly used assessments are able to effectively and comprehensively measure neglect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemispatial Neglect
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 21 Feb 2020
- Phase
- Observational
- 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
Study population: Stroke survivors
Who may be able to join
- Unilateral hemispheric stroke
- 18 years or older
Who cannot join
- Severe aphasia
- Inability to follow 2-step directions
- Presence of other neurological disease that may impair vision or perception during performance of evaluation procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
The purpose of this study is to examine measurement of unilateral neglect post stroke. Although a number of clinical assessments are used to measure neglect, it is unclear whether items from some of the most commonly used assessments are able to effectively and comprehensively measure neglect. This study will determine whether these assessments measure different aspects of neglect and whether items from various neglect assessments can be combined to more effectively measure neglect.
Read the detailed description
Many individuals have difficulty attending to the affected side of their body or to the affected side of space after stroke (unilateral neglect). Although a number of clinical assessments are used to measure this inattention, it is unclear whether items from some of the most commonly used assessments are able to effectively and comprehensively measure inattention. Clinical assessments provide critical information to clinicians and researchers and are used to inform treatment and document patient progress. Therefore, it is important that investigators more closely examine these existing assessments.
Individuals who demonstrate impaired attention to the affected side after stroke also have greater motor impairment than individuals who do not have impaired attention, but investigators do not know how inattention affects reaching movements using the impaired arm. This study will examine various methods used to assess inattention to the affected side after stroke and also examine how inattention affects reaching movements of the impaired arm.
- Conditions
- Stroke, Hemispatial Neglect
- Keywords
- Stroke, Neglect, Rehabilitation
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Stroke Survivors | Individuals who have experienced a unilateral hemispheric stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catherine Bergego Scale
Measured: One-time assessment scheduled over 1-2 days
Behavioral Inattention Test
Measured: One-time assessment scheduled over 1-2 days
Naturalistic Action Test
Measured: One-time assessment scheduled over 1-2 days
Virtual Reality Lateralized Attention Test
Measured: One-time assessment scheduled over 1-2 days
Kinematic Assessment of Arm Movement
Measured: One-time assessment scheduled over 1-2 days
Secondary outcomes (1)
Arm Use measured by Accelerometers
Accelerometers will be issued on the first assessment day. Participants will wear accelerometers for 3 days.
Measured: One-time assessment scheduled over 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startJan 2016
- Primary completion21 Feb 2020
- Study completion21 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Woodbury, Medical University of South Carolina
- Investigators
- Michelle Woodbury, PhD, OTR/L, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935270
- Sponsor's protocol ID
- PR00044531
- Status last verified
- Nov 2022
- First submitted
- 12 Oct 2016
- Last updated
- 25 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Grattan ES, Woodbury ML. Do Neglect Assessments Detect Neglect Differently? Am J Occup Ther. 2017 May/Jun;71(3):7103190050p1-7103190050p9. doi: 10.5014/ajot.2017.025015.
PubMed 28422631
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Measurement of Behavioral Neglect Post Stroke
- ClinicalTrials.gov ID
- NCT02935270
- Acronym / sponsor ID
- PR00044531
- Conditions
- Stroke, Hemispatial Neglect
- Keywords
- Stroke, Neglect, Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 21 Feb 2020 (actual)
- Study completion
- 21 Feb 2020 (actual)
- First posted
- 17 Oct 2016 (estimated)
- 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.
The purpose of this study is to examine measurement of unilateral neglect post stroke. Although a number of clinical assessments are used to measure neglect, it is unclear whether items from some of the most commonly used assessments are able to effectively and comprehensively measure neglect. This study will determine whether these assessments measure different aspects of neglect and whether items from various neglect assessments can be combined to more effectively measure neglect.
Detailed description
Many individuals have difficulty attending to the affected side of their body or to the affected side of space after stroke (unilateral neglect). Although a number of clinical assessments are used to measure this inattention, it is unclear whether items from some of the most commonly used assessments are able to effectively and comprehensively measure inattention. Clinical assessments provide critical information to clinicians and researchers and are used to inform treatment and document patient progress. Therefore, it is important that investigators more closely examine these existing assessments.
Individuals who demonstrate impaired attention to the affected side after stroke also have greater motor impairment than individuals who do not have impaired attention, but investigators do not know how inattention affects reaching movements using the impaired arm. This study will examine various methods used to assess inattention to the affected side after stroke and also examine how inattention affects reaching movements of the impaired arm.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke Survivors | – | –Individuals who have experienced a unilateral hemispheric stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke survivors
Key inclusion criteria (2 listed)
- Unilateral hemispheric stroke
- 18 years or older
Key exclusion criteria (3 listed)
- Severe aphasia
- Inability to follow 2-step directions
- Presence of other neurological disease that may impair vision or perception during performance of evaluation procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Catherine Bergego Scale
Time frame: One-time assessment scheduled over 1-2 days
Behavioral Inattention Test
Time frame: One-time assessment scheduled over 1-2 days
Naturalistic Action Test
Time frame: One-time assessment scheduled over 1-2 days
Virtual Reality Lateralized Attention Test
Time frame: One-time assessment scheduled over 1-2 days
Kinematic Assessment of Arm Movement
Time frame: One-time assessment scheduled over 1-2 days
1 secondary outcome
Arm Use measured by Accelerometers
Time frame: One-time assessment scheduled over 3 days
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 25 Nov 2022.
- Derived from this study: PubMed 28422631Grattan ES, Woodbury ML. Do Neglect Assessments Detect Neglect Differently? Am J Occup Ther. 2017 May/Jun;71(3):7103190050p1-7103190050p9. doi: 10.5014/ajot.2017.025015.
- 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.
Michelle Woodbury, PhD, OTR/L principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Hemispatial Neglect, run by Medical University of South Carolina 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 2 inclusion and 3 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 25 Nov 2022. 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?
Catherine Bergego Scale (time frame: One-time assessment scheduled over 1-2 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02935270, which also lists 1 linked publication.
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 25 Nov 2022.