- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02068664
An Assessment of the Prevalence of Spatial Neglect in Stroke Survivors With Aphasia
August 16, 2017 updated by: Kessler Foundation
An Assessment of the Prevalence of Spatial Neglect in Stroke Survivors With Aphasia With Option of Prism Adaptation Treatment (PAT) Protocol
The purpose of this study is to determine if stroke survivors with aphasia have spatial neglect (Phase 1).
If they are determined to have the condition Phase 2 will be offered: which is prism adaptation treatment.
This is a pilot study that will be performed with 4-5 subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Spatial neglect is a disorder that may occur after a brain injury such as stroke.
Spatial neglect may affect stroke recovery.
One example of this heterogeneous condition: Individuals with spatial neglect often pay more attention to one side of what they are looking at, even though they have no difficulty seeing.
The study investigators would like to screen stroke survivors with aphasia because they may also have spatial neglect (right neglect after left hemisphere stroke), which is said by the literature to occur in 25% of cases.
If it is identified, a treatment approach will be offered, to attempt to remediate the condition using prism goggles, following a prism treatment protocol based on previous studies.
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New Jersey
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Maywood, New Jersey, United States, 07607
- Adler Aphasia Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Stroke survivors with aphasia and spatial neglect
Description
Inclusion Criteria:
- A stroke survivor with aphasia who is a member at the Adler Aphasia Center
Exclusion Criteria:
- Has a history of brain tumor, head injury with loss of consciousness, dementia, alzheimers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational
prism adaptation treatment
|
Prism goggles shift the image one sees toward the left (because the thicker portion of the glass lens is on the right).
This will change the perception of where the image is in space, causing the person to adapt.
The after-effects of the treatment is what is important.
It has been shown to make it easier for people to move in the right space (if have right neglect) or improves ability to complete other functional tasks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kessler Foundation Neglect Assessment Process
Time Frame: 2 weeks
|
a performance based and behavioral measure for spatial neglect that utilizes and standardizes the administration of the Catherine Bergego Scale (CBS)
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavior Inattention Test
Time Frame: 2 weeks
|
Conventional subtest, a set of paper and pencil test for spatial neglect
|
2 weeks
|
|
Barthel Index
Time Frame: 2 weeks
|
A functional independence assessment of daily tasks
|
2 weeks
|
|
University of Alabama at Birmingham (UAB) Life Space assessment
Time Frame: 2 weeks
|
a self graded assessment on community mobility and participation
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kimberly Hreha, OT, Kessler Foundation/Kessler Institute for Rehabilitation
- Principal Investigator: A.M. Barrett, M.D., Kessler Foundation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
February 12, 2014
First Submitted That Met QC Criteria
February 20, 2014
First Posted (Estimate)
February 21, 2014
Study Record Updates
Last Update Posted (Actual)
August 21, 2017
Last Update Submitted That Met QC Criteria
August 16, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-802-13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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