NCT01529723

Brief Summary

Dysphagia or swallowing difficulty is common after stroke occurring in 25-78% of stroke survivors depending on the anatomic location of the stroke and the diagnostic test used. There are no universally accepted methods for doing a screen test at the bedside in the immediate setting after stroke. This study will assess the reliability of a bedside screen in terms of reproducibility of results between 2 independent screeners and in comparison to a fiberoptic study done by a speech language pathologist.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

February 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

April 11, 2016

Status Verified

April 1, 2016

Enrollment Period

3 months

First QC Date

February 6, 2012

Last Update Submit

April 7, 2016

Conditions

Stroke

Keywords

StrokeDysphagia screening

Eligibility Criteria

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

Patients with acute ischemic stroke

You may qualify if:

  • Clinical diagnosis of ischemic stroke
  • Age 18 years or older
  • NIHSS 8-16
  • Within 24 hours of last known well

You may not qualify if:

  • Diagnosis of intracerebral hemorrhage, TIA, or other non-ischemic stroke diagnosis
  • Patient or authorized representative unable to read consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Brian Silver, MD

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Stroke Center

Study Record Dates

First Submitted

February 6, 2012

First Posted

February 9, 2012

Study Start

February 1, 2012

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

April 11, 2016

Record last verified: 2016-04

Locations

US(1)