Not provided
Not provided
Not provided
Not provided
Very limited enrollment
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Baylor Health Care System | OTHER |
| St.David's Rehabilitation Hospital (Austin, Texas) | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| early standardized task training | Experimental | Persons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early standardized task training | Other | Early standardized task training is a treatment approach using treadmill training applied very early after stroke onset. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Karen J McCain, PT, DPT, NCS | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. David's Rehabilitation Hospital | Austin | Texas | 78705 | United States | ||
| Baylor Institute for Rehabilitation - Dallas |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | cm/sec | 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. |
|
|
1.5 years
no adverse events were reported
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ESTT | early standardized treadmill training |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen McCain, PT, DPT, NCS, Principal Investigator | University of Texas Southwestern Medical Center | 214-648-1559 | karen.mccain@utsouthwestern.edu |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment |
| Dallas |
| Texas |
| 75246 |
| United States |
| Baylor Institute for Rehabilitation - Northwest | Dallas | Texas | 75247 | United States |
| Baylor Institute for Rehabilitation - Frisco | Frisco | Texas | 75034 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 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. | Posted | Mean | Standard Deviation | scores on a scale | This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment |
|
|
|
| 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. | Posted | Mean | Standard Deviation | feet | This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |