Clinical trial NCT01774110: Evaluation of Early Standardized Task-Specific Training (ESTT)
Official title: Evaluation of Early Standardized Task-Specific Training (ESTT) in Persons With Acute Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Stroke
Keywords: stroke
gait
acute
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Baylor Health Care System
name: St.David's Rehabilitation Hospital (Austin, Texas)
First posted: 2013-01-23
Enrollment: 12
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Walking Velocity From Initial Assessment to Completion of Study at 6 Months Post Enrollment
timeFrame: 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:
measure: Change in Score on Stroke Rehabilitation Assessment of Movement (STREAM) Test From Initial Assessment to Discharge From Study.
timeFrame: This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment
Other outcomes:
measure: Change in 6-Minute Walk Test Distance From Time of Discharge From Rehabilitation (Initial Assessment) to 6 Months Post Enrollment
timeFrame: This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment
Locations:
city: Austin
country: United States
facility: St. David's Rehabilitation Hospital
state: Texas
city: Dallas
country: United States
facility: Baylor Institute for Rehabilitation - Dallas
state: Texas
city: Dallas
country: United States
facility: Baylor Institute for Rehabilitation - Northwest
state: Texas
city: Frisco
country: United States
facility: Baylor Institute for Rehabilitation - Frisco
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Karen J McCain, PT, DPT, NCS
role: PRINCIPAL_INVESTIGATOR
References: