NCT01774110

Brief Summary

A. Specific Aims: 1\. There is one specific aim of this study. The aim is to evaluate the effectiveness of early standardized task-specific training (ESTT) in persons with acute stroke. B. Hypothesis: 1\. It is our hypothesis that subjects who receive ESTT will walk faster and more symmetrically than published reports of gait outcomes in persons with stroke.

Trial Health

57
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Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
1.9 years 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
6 months until next milestone

Results Posted

Study results publicly available

June 2, 2015

Completed
Last Updated

October 1, 2015

Status Verified

September 1, 2015

Enrollment Period

2.3 years

First QC Date

January 18, 2013

Results QC Date

May 13, 2015

Last Update Submit

September 1, 2015

Conditions

Acute Stroke

Keywords

strokegaitacute

Outcome Measures

Primary Outcomes (1)

  • Change in Walking Velocity From Initial Assessment to Completion of Study at 6 Months Post Enrollment

    Computerized gait analysis is done by a mat system (GAITRite) that electronically calculates the velocity.

    This will be done at the time of discharge from inpatient rehabilitation (the initial assessment point of the study) and at 6-months post enrollment.

Secondary Outcomes (1)

  • Change in Score on Stroke Rehabilitation Assessment of Movement (STREAM) Test From Initial Assessment to Discharge From Study.

    This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment

Other Outcomes (1)

  • Change in 6-Minute Walk Test Distance From Time of Discharge From Rehabilitation (Initial Assessment) to 6 Months Post Enrollment

    This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment

Study Arms (1)

early standardized task training

EXPERIMENTAL

Persons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke.

Other: Early standardized task training

Interventions

Early standardized task trainingOTHER

Early standardized task training is a treatment approach using treadmill training applied very early after stroke onset.

Also known as: ESTT
early standardized task training

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Recent stroke (less than 6 weeks)
  • Able to give conformed consent or have family member who can give consent
  • first time stroke OR complete recovery from prior stroke

You may not qualify if:

  • non-ambulatory before onset of stroke
  • bilateral stroke
  • presence of severe cardiac problems
  • other co-morbidities which would affect gait training (i.e. amputation, spinal cord injury, traumatic brain injury, etc.)
  • recent myocardial infarct (within 4 weeks)
  • any uncontrolled health condition for which exercise is contraindicated
  • severe lower extremity joint disease/pathology that would interfere with gait training
  • subjects with BMI greater than 40
  • significant cognitive impairment
  • age greater than 80 years or less than 16 years
  • able to complete 5 or more full heel raises with the affected ankle in standing with the knee extended with no more than one or two fingers on support surface for balance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

St. David's Rehabilitation Hospital

Austin, Texas, 78705, United States

Location

Baylor Institute for Rehabilitation - Dallas

Dallas, Texas, 75246, United States

Location

Baylor Institute for Rehabilitation - Northwest

Dallas, Texas, 75247, United States

Location

Baylor Institute for Rehabilitation - Frisco

Frisco, Texas, 75034, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Karen McCain, PT, DPT, NCS, Principal Investigator
Organization
University of Texas Southwestern Medical Center
karen.mccain@utsouthwestern.edu
214-648-1559

Study Officials

  • Karen J McCain, PT, DPT, NCS

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Physical Therapy, School of Health Professions

Study Record Dates

First Submitted

January 18, 2013

First Posted

January 23, 2013

Study Start

August 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

October 1, 2015

Results First Posted

June 2, 2015

Record last verified: 2015-09

Locations

US(4)