Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 77797 | Other Identifier | Charleston VAMC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the use of incline and decline treadmill training to address specific motor control deficits identified within different post-stroke walking patterns.
This study seeks to develop a theory-based clinical decision-making framework for the training of walking recovery after stroke based on how different biomechanical patterns of walking illustrate distinct motor control deficits. Each participant will complete 12 sessions (three times a week for four weeks) of either INCLINE, DECLINE, or CONTROL training. Clinical and biomechanical outcome measures will be collected pre- and post-training and after a one-month follow-up period. In addition, the investigators will collect a battery of clinical outcome measures before and after training. Spatiotemporal variables (including SSWS) will be collected before and after each session. All clinical and biomechanical assessments will be conducted by an evaluator blinded to training group allocation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized training effect on SSWS and Pp - Incline | Active Comparator | Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp). Incline treadmill walking: Those with a Pp <0.47 or >0.53 will undergo INCLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs. |
|
| Personalized training effect on SSWS and Pp - Decline | Active Comparator | Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp). Decline treadmill walking: Those with a Pp <0.47 or >0.53 will undergo DECLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs. |
|
| Personalized training effect on SSWS and Pp - Level treadmill (Control) | Active Comparator | Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp). Level treadmill walking: Those with a Pp <0.47 or >0.53 will undergo LEVEL training during which individuals will walk for 15 minutes at a 0-degree treadmill tilt, stopping each five minutes for monitoring of vital signs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Incline treadmill walking | Other | Those with a Pp <0.47 or >0.53 will undergo INCLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gait Speed | Participants will be asked to complete a 10 Meter Walk Test and a difference will be calculated between pre and post speed. | Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Paretic Propulsion Symmetry | Quantitative measure of the coordinated output of the paretic leg and is defined as the percentage of propulsion performed by the paretic leg. | Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brian Cence | Ralph H. Johnson VA Medical Center, Charleston, SC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ralph H. Johnson VA Medical Center, Charleston, SC | Charleston | South Carolina | 29401-5799 | United States | ||
As a clinical trial, the details of this project will be entered into ClinicalTrials.gov. Clinical data from assessment sessions will be recorded on hard copies (stored in a locked file cabinet in the Ralph H. Johnson VAMC rehabilitation research space) and entered into a RedCAP electronic database by the project coordinator immediately after each session. These data will be de-identified for further analysis. Only the PI will only have access to de-identified data. Gait data will be analyzed using a custom MATLAB program, automatically populating a LabView Data Viewer from which customized data may be retrieved. The research coordinator will check the data entry, and pool all data into a group-wide de-identified spreadsheet. All data from training sessions will also be analyzed and stored using an automated MATLAB program. All electronic data will be stored on a secure server that is backed-up nightly.
Completion of all study Aims. De-identified data set will be available for other investigators and registered in the NIH-supported registry.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Personalized Training Effect on SSWS and Pp - Incline | Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp). Incline treadmill walking: Those with a Pp <0.47 or >0.53 will undergo INCLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs. |
| FG001 | Personalized Training Effect on SSWS and Pp - Decline | Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp). Decline treadmill walking: Those with a Pp <0.47 or >0.53 will undergo DECLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs. |
| FG002 | Personalized Training Effect on SSWS and Pp - Level Treadmill (Control) | Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp). Level treadmill walking: Those with a Pp <0.47 or >0.53 will undergo LEVEL treadmill training during which individuals will walk for 15 minutes at a 0-degree treadmill tilt, stopping each five minutes for monitoring of vital signs. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Personalized Training Effect on SSWS and Pp - Incline | Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp). Incline treadmill walking: Those with a Pp <0.47 or >0.53 will undergo INCLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs. |
| 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 Gait Speed | Participants will be asked to complete a 10 Meter Walk Test and a difference will be calculated between pre and post speed. | Posted | Mean | Standard Deviation | meters/second | Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart. |
|
75 days
Records were kept of non-serious adverse events in the study binder and reported to the local governing IRB in accordance with Good Clinical Practice Guidelines.
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 | Personalized Training Effect on SSWS and Pp - Incline | Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp). Incline treadmill walking: Those with a Pp <0.47 or >0.53 will undergo INCLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs. |
Not provided
Not provided
We did not reach our target number of 60 participants due to the COVID-19 pandemic. The formatting of our study at its conclusion is different than its original presentation. Our 'arms' are updated as the incline, decline, and level treadmill conditions. We present gait speed and Pp outcomes across three conditions in our final report. We caution interpretation due to the potential impact of paretic propulsion baseline characteristic on the response to incline or decline walking conditions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark G. Bowden - PI | Brooks Rehabilitation Clinical Research Center | 904-345-6626 | mark.bowden@brooksrehab.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 6, 2023 | Jun 7, 2023 | Prot_SAP_000.pdf |
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
| Decline treadmill walking | Other | Those with a Pp <0.47 or >0.53 will undergo DECLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs. |
|
| Level Treadmill (Control) | Other | Those with a Pp <0.47 or >0.53 will undergo LEVEL training during which individuals will walk for 15 minutes at a 0-degree treadmill tilt, stopping each five minutes for monitoring of vital signs. |
|
| MUSC Center for Rehabilitation Research in Neurologic Conditions |
| Charleston |
| South Carolina |
| 29425 |
| United States |
| BG001 | Personalized Training Effect on SSWS and Pp - Decline | Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp). Decline treadmill walking: Those with a Pp <0.47 or >0.53 will undergo DECLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs. |
| BG002 | Personalized Training Effect on SSWS and Pp - Level Treadmill (Control) | Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp). Level treadmill walking: Those with a Pp <0.47 or >0.53 will undergo LEVEL training during which individuals will walk for 15 minutes at a 0-degree treadmill tilt, stopping each five minutes for monitoring of vital signs. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp). Decline treadmill walking: Those with a Pp <0.47 or >0.53 will undergo DECLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs. |
| OG002 | Personalized Training Effect on SSWS and Pp - Level Treadmill (Control) | Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp). Level treadmill walking: Those with a Pp <0.47 or >0.53 will undergo LEVEL training during which individuals will walk for 15 minutes at a 0-degree treadmill tilt, stopping each five minutes for monitoring of vital signs. |
|
|
| Secondary | Change in Paretic Propulsion Symmetry | Quantitative measure of the coordinated output of the paretic leg and is defined as the percentage of propulsion performed by the paretic leg. | Posted | Mean | Standard Deviation | Percentage of Propulsion | Pre (same day but prior to initial training session) and post (immediately following final training session) approximately 4 weeks apart. |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Personalized Training Effect on SSWS and Pp - Decline | Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp). Decline treadmill walking: Those with a Pp <0.47 or >0.53 will undergo DECLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG002 | Personalized Training Effect on SSWS and Pp - Level Treadmill (Control) | Determine the efficacy of motor control deficit guided personalized training on SSWS and Paretic Propulsion (Pp). Level treadmill walking: Those with a Pp <0.47 or >0.53 will undergo LEVEL training during which individuals will walk for 15 minutes at a 0-degree treadmill tilt, stopping each five minutes for monitoring of vital signs. | 0 | 17 | 0 | 17 | 0 | 17 |
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |