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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02935270
Other study ID # PR00044531
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2016
Est. completion date February 21, 2020

Study information

Verified date November 2022
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date February 21, 2020
Est. primary completion date February 21, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Unilateral hemispheric stroke - 18 years or older Exclusion Criteria: - Severe aphasia - Inability to follow 2-step directions - Presence of other neurological disease that may impair vision or perception during performance of evaluation procedures

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Medical University of South Carolina Charleston South Carolina

Sponsors (1)

Lead Sponsor Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Catherine Bergego Scale One-time assessment scheduled over 1-2 days
Primary Behavioral Inattention Test One-time assessment scheduled over 1-2 days
Primary Naturalistic Action Test One-time assessment scheduled over 1-2 days
Primary Virtual Reality Lateralized Attention Test One-time assessment scheduled over 1-2 days
Primary Kinematic Assessment of Arm Movement One-time assessment scheduled over 1-2 days
Secondary Arm Use measured by Accelerometers Accelerometers will be issued on the first assessment day. Participants will wear accelerometers for 3 days. One-time assessment scheduled over 3 days
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