Acute Stroke
Conditions
Keywords
stroke, gait, acute
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.
Interventions
OTHEREarly standardized task training
Early standardized task training is a treatment approach using treadmill training applied very early after stroke onset.
Sponsors
Baylor Health Care System
St.David's Rehabilitation Hospital (Austin, Texas)
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Walking Velocity From Initial Assessment to Completion of Study at 6 Months Post Enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | The 6-Minute Walk Test is a test of walking endurance and walking velocity. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Early Standardized Task Training Persons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke.
Early standardized task training: Early standardized task training is a treatment approach using treadmill training applied very early after stroke onset. | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 7 |
Baseline characteristics
| Characteristic | Early Standardized Task Training |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
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.
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTT | Change in Walking Velocity From Initial Assessment to Completion of Study at 6 Months Post Enrollment | 35.83 cm/sec | Standard Deviation 29.36 |
Secondary
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.
Time frame: This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTT | Change in Score on Stroke Rehabilitation Assessment of Movement (STREAM) Test From Initial Assessment to Discharge From Study. | 28.63 scores on a scale | Standard Deviation 13.78 |
Other Pre-specified
Change in 6-Minute Walk Test Distance From Time of Discharge From Rehabilitation (Initial Assessment) to 6 Months Post Enrollment
The 6-Minute Walk Test is a test of walking endurance and walking velocity.
Time frame: This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTT | Change in 6-Minute Walk Test Distance From Time of Discharge From Rehabilitation (Initial Assessment) to 6 Months Post Enrollment | 448.66 feet | Standard Deviation 215.77 |