NCT02098083

Brief Summary

Data collection for this study will be done by clinicians working in inpatient rehabilitation units with persons with acute stroke. No interventions are included in this study. It is designed to capture trends in current clinical practice for persons with stroke. This data will be useful in identifying the most beneficial and effective walking treatments as well as most significant patient characteristics that impact recovery for persons acutely after stroke. All data collection will take place during the inpatient rehabilitation stay.

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 Nov 2013

Geographic Reach
1 country

4 active sites

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withdrawn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

November 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

1.1 years

First QC Date

March 20, 2014

Last Update Submit

July 29, 2015

Conditions

Keywords

acutestrokegait

Outcome Measures

Primary Outcomes (1)

  • 6-Minute Walk Test

    The 6-Minute Walk Test is a test of walking endurance that is valid and reliable for persons post stroke.

    Subjects will be followed for the duration of inpatient rehabilitation, an expected average of 4 weeks

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Persons post stroke admitted to inpatient rehabilitation units

You may qualify if:

  • Any patient with a confirmed primary diagnosis of stroke, within 6 weeks of onset, will be included.
  • Persons will be between the ages of 16 and 80.
  • Persons may have experienced a previous CVA if they experienced a full gait recovery.

You may not qualify if:

  • Any patient with a history of stroke onset greater than 6 weeks prior to admission will not be included.
  • In addition, persons with bilateral CVA will not be included as well as persons who were not ambulatory prior to the CVA.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Baylor Institute for Rehabilitation

Dallas, Texas, 75246, United States

Location

Baylor All Saints

Fort Worth, Texas, 76104, United States

Location

Baylor Institute for Rehabilitation Frisco

Frisco, Texas, 75034, United States

Location

Baylor Medical Center of Irving

Irving, Texas, 75061, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Karen J McCain, PT, DPT, NCS

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 20, 2014

First Posted

March 27, 2014

Study Start

November 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations