NCT02935270

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2020

Completed
Last Updated

November 25, 2022

Status Verified

November 1, 2022

Enrollment Period

4.1 years

First QC Date

October 12, 2016

Last Update Submit

November 22, 2022

Conditions

Keywords

StrokeNeglectRehabilitation

Outcome Measures

Primary Outcomes (5)

  • Catherine Bergego Scale

    One-time assessment scheduled over 1-2 days

  • Behavioral Inattention Test

    One-time assessment scheduled over 1-2 days

  • Naturalistic Action Test

    One-time assessment scheduled over 1-2 days

  • Virtual Reality Lateralized Attention Test

    One-time assessment scheduled over 1-2 days

  • Kinematic Assessment of Arm Movement

    One-time assessment scheduled over 1-2 days

Secondary Outcomes (1)

  • Arm Use measured by Accelerometers

    One-time assessment scheduled over 3 days

Study Arms (1)

Stroke Survivors

Individuals who have experienced a unilateral hemispheric stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stroke survivors

You may qualify if:

  • Unilateral hemispheric stroke
  • years or older

You may not qualify if:

  • Severe aphasia
  • Inability to follow 2-step directions
  • Presence of other neurological disease that may impair vision or perception during performance of evaluation procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

StrokePerceptual Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michelle Woodbury, PhD, OTR/L

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post Doctoral Scholar

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 17, 2016

Study Start

January 1, 2016

Primary Completion

February 21, 2020

Study Completion

February 21, 2020

Last Updated

November 25, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations