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An Assessment of the Prevalence of Spatial Neglect in Stroke Survivors With Aphasia

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Kessler Foundation
Sponsor:
Information provided by (Responsible Party):
Kessler Foundation
ClinicalTrials.gov Identifier:
NCT02068664
First received: February 12, 2014
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Spatial Neglect
Aphasia
Stroke
Behavioral: prism adaptation treatment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Assessment of the Prevalence of Spatial Neglect in Stroke Survivors With Aphasia With Option of Prism Adaptation Treatment (PAT) Protocol

Resource links provided by NLM:


Further study details as provided by Kessler Foundation:

Primary Outcome Measures:
  • Kessler Foundation Neglect Assessment Process [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    a performance based and behavioral measure for spatial neglect that utilizes and standardizes the administration of the Catherine Bergego Scale (CBS)


Secondary Outcome Measures:
  • Behavior Inattention Test [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Conventional subtest, a set of paper and pencil test for spatial neglect

  • Barthel Index [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    A functional independence assessment of daily tasks

  • University of Alabama at Birmingham (UAB) Life Space assessment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    a self graded assessment on community mobility and participation


Estimated Enrollment: 105
Study Start Date: February 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Behavioral treatment
Behavioral treatment
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02068664

Contacts
Contact: Kimberly Hreha, OT 973 768 5346 khreha@kesslerfoundation.org

Locations
United States, New Jersey
Adler Aphasia Center Recruiting
Maywood, New Jersey, United States, 07607
Contact: Gretchen Szabo, SLP       gszabo@adlerapasiacenter.org   
Principal Investigator: Kimberly Hreha, OT         
Sponsors and Collaborators
Kessler Foundation
Investigators
Principal Investigator: Kimberly Hreha, OT Kessler Foundation/Kessler Institute for Rehabilitation
Principal Investigator: A.M. Barrett, M.D. Kessler Foundation
  More Information

Additional Information:
No publications provided

Responsible Party: Kessler Foundation
ClinicalTrials.gov Identifier: NCT02068664     History of Changes
Other Study ID Numbers: R-802-13
Study First Received: February 12, 2014
Last Updated: February 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Kessler Foundation:
spatial neglect
aphasia

Additional relevant MeSH terms:
Aphasia
Cerebral Infarction
Perceptual Disorders
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Communication Disorders
Language Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Speech Disorders
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014