Evaluation of Early Standardized Task-Specific Training (ESTT)

NCT ID: NCT01774110

Last Updated: 2015-10-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-12-31

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.

Detailed Description

It is our contention that gait recovery after stroke is impacted by the interventions that are acutely utilized during training. There is not a consensus about how to most effectively train individuals after stroke. It is clear, however, that most persons are left with significant and often debilitating gait dysfunction after stroke so there is an urgent need to find more effective therapeutic methods.

Conditions

Acute Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

early standardized task training

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

Group Type: EXPERIMENTAL

Early standardized task training

Intervention Type: OTHER

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

Interventions

Early standardized task training

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

Intervention Type: OTHER

Other Intervention Names

ESTT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor Health Care System

OTHER

Sponsor Role: collaborator

St.David's Rehabilitation Hospital (Austin, Texas)

UNKNOWN

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Karen McCain

Associate Professor, Physical Therapy, School of Health Professions

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen J McCain, PT, DPT, NCS

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

St. David's Rehabilitation Hospital

Austin, Texas, United States

Baylor Institute for Rehabilitation - Dallas

Dallas, Texas, United States

Baylor Institute for Rehabilitation - Northwest

Dallas, Texas, United States

Baylor Institute for Rehabilitation - Frisco

Frisco, Texas, United States

Countries

United States

Other Identifiers

ESTT

Identifier Type: -

Identifier Source: org_study_id