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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02068664
Other study ID # R-802-13
Secondary ID
Status Completed
Phase N/A
First received February 12, 2014
Last updated August 16, 2017
Start date February 2014
Est. completion date December 2016

Study information

Verified date August 2017
Source Kessler Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
United States Adler Aphasia Center Maywood New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Kessler Foundation Neglect Assessment Process a performance based and behavioral measure for spatial neglect that utilizes and standardizes the administration of the Catherine Bergego Scale (CBS) 2 weeks
Secondary Behavior Inattention Test Conventional subtest, a set of paper and pencil test for spatial neglect 2 weeks
Secondary Barthel Index A functional independence assessment of daily tasks 2 weeks
Secondary University of Alabama at Birmingham (UAB) Life Space assessment a self graded assessment on community mobility and participation 2 weeks
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