Acute StrokeESTTNCT01774110
Evaluation of Early Standardized Task-Specific Training (ESTT)
A study testing Early standardized task training in people with Acute Stroke, run by University of Texas Southwestern Medical Center at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Early standardized task training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
St. David's Rehabilitation Hospital
Austin, Texas, 78705
Baylor Institute for Rehabilitation - Dallas
Dallas, Texas, 75246
Baylor Institute for Rehabilitation - Northwest
Dallas, Texas, 75247
Baylor Institute for Rehabilitation - Frisco
Frisco, Texas, 75034
About this study
Official title: Evaluation of Early Standardized Task-Specific Training (ESTT) in Persons With Acute Stroke
- Specific Aims:
- 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.
- Hypothesis:
- 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.
Read the 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
- Being tested
- Early standardized task training
- Keywords
- stroke, gait, acute
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early standardized task trainingOther
Also called ESTT
Early standardized task training is a treatment approach using treadmill training applied very early after stroke onset.
| Study group | Role | What they receive |
|---|---|---|
| early standardized task training | Experimental | Persons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke. Receives: Other: Early standardized task training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
The Stroke Rehabilitation Assessment of Movement (STREAM) is a test of motor recovery after stroke. There are 3 subsections of the test, an upper extremity section, a lower extremity section and a mobility section. Each section is scored independently and is normed to 100 points. Each of the 3 sections is then combined into a total overall function score which is also normed to 100. Therefore, a score of 100 represents full recovery whereas a score of 50 represents about 50% recovery from the stroke.
Measured: This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startAug 2012
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Very limited enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor Health Care System, St.David's Rehabilitation Hospital (Austin, Texas)
- Responsible party
- Principal investigator, Karen McCain, University of Texas Southwestern Medical Center
- Investigators
- Karen J McCain, PT, DPT, NCS, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774110
- Sponsor's protocol ID
- ESTT
- Acronym
- ESTT
- Status last verified
- Sep 2015
- First submitted
- 18 Jan 2013
- Last updated
- 1 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Early Standardized Task-Specific Training (ESTT) in Persons With Acute Stroke
- ClinicalTrials.gov ID
- NCT01774110
- Acronym / sponsor ID
- ESTT / ESTT
- Conditions
- Acute Stroke
- Keywords
- stroke, gait, acute
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Very limited enrollment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Baylor Health Care System, St.David's Rehabilitation Hospital (Austin, Texas)
- Study start
- Aug 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Posted 2 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Specific Aims:
- 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.
- Hypothesis:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| early standardized task training | Experimental | Other: Early standardized task trainingPersons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early standardized task trainingAlso: ESTTEarly standardized task training is a treatment approach using treadmill training applied very early after stroke onset. | Other | early standardized task training |
Primary outcome
Change in Walking Velocity From Initial Assessment to Completion of Study at 6 Months Post Enrollment
Time frame: 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.
Computerized gait analysis is done by a mat system (GAITRite) that electronically calculates the velocity.
1 secondary outcome
Change in Score on Stroke Rehabilitation Assessment of Movement (STREAM) Test From Initial Assessment to Discharge From Study.
Time frame: This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Stroke, Acute Ischemic, Medium Vessel Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen J McCain, PT, DPT, NCS principal investigator
University of Texas Southwestern Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early standardized task training in people with Acute Stroke, run by University of Texas Southwestern Medical Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Walking Velocity From Initial Assessment to Completion of Study at 6 Months Post Enrollment (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2015.