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| ID | Type | Description | Link |
|---|---|---|---|
| RX002256 | Other Grant/Funding Number | VA ORD |
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The purpose of this study is to determine whether a novel treadmill training intervention can improve the gait stabilization strategy used by individuals who have experienced a stroke.
Every year, approximately 15,000 American Veterans experience a stroke, with an estimated cost of acute and follow-up care in the hundreds of millions of dollars. Following a stroke, the restoration or improvement of walking is a high-ranking goal among patients, but only about half of the population is able to return to typical levels of community ambulation. The resultant decrease in independent mobility is strongly associated with a decline in quality of life. Gait instability is a common contributor to limited mobility through either an increased fall-risk or fear of falling, but current interventions to address post-stroke gait instability have had limited success. This project will conduct initial testing of a novel elastic force-field designed to improve post-stroke gait stability through targeted motor learning. The results of these experiments will serve as the basis for the development of novel gait rehabilitation techniques, which have the potential to increase the quality of life of thousands of Veterans and save millions of dollars.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Error reduction | Experimental | Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error reduction" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period. |
|
| Error augmentation | Experimental | Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error augmentation" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period. |
|
| Activity matched control | Sham Comparator | Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "transparent" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Error reduction | Behavioral | During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke. |
| Measure | Description | Time Frame |
|---|---|---|
| Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline) | A custom measure that quantifies the strength of the relationship between body mechanics and foot placement. This measure falls within a relatively narrow range among neurologically intact controls, but is substantially reduced in some individuals who have experienced a stroke, indicating a reduced ability to stabilize their gait pattern. This measure relates the mechanical state of the body at the start of each step (mediolateral pelvis displacement and velocity of the pelvis relative to the stance foot) to the step width at the end of the step. Specifically, the partial linear correlation between pelvis displacement and step width was calculated, accounting for variation in pelvis velocity. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks). | baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Gait Assessment (Change From Baseline) | A commonly-used clinical test to quantify balance and stability during various walking tasks. The minimum value is 0, the maximum value is 30, and higher scores indicate better outcomes. The total maximum value of 30 is calculated as the sum of 10 subscores, each of which has a scoring range of 0-3 and represents a distinct walking task. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesse C. Dean, PhD | 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 |
De-identified, anonymized data sets will be available to other investigators or members of the public upon request. These data sets will be made available upon completion of data collection, processing, and initial statistical analyses. The data sets will include physiological measures related to functional mobility, as well as the results of clinical tests.
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Of the 93 participants who were assessed for eligibility, 54 met the study's inclusion criteria and were interested in participating in the intervention. These 54 participants were randomized to one of the three study arms.
Participants were recruited and enrolled between February 2017 and October 2019 from a database housed at the Medical University of South Carolina. Individuals in this database had previously experienced a stroke, and had agreed to be contacted for participation in research studies.
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| ID | Title | Description |
|---|---|---|
| FG000 | Error Reduction | Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error reduction" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period. Error reduction: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke. |
| FG001 | Error Augmentation | Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error augmentation" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period. Error augmentation: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke. |
| FG002 | Activity Matched Control | Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "transparent" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period. Activity matched control: During training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Error Reduction | Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error reduction" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period. Error reduction: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline) | A custom measure that quantifies the strength of the relationship between body mechanics and foot placement. This measure falls within a relatively narrow range among neurologically intact controls, but is substantially reduced in some individuals who have experienced a stroke, indicating a reduced ability to stabilize their gait pattern. This measure relates the mechanical state of the body at the start of each step (mediolateral pelvis displacement and velocity of the pelvis relative to the stance foot) to the step width at the end of the step. Specifically, the partial linear correlation between pelvis displacement and step width was calculated, accounting for variation in pelvis velocity. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks). | The total of 44 participants analyzed corresponds to the participants who completed the intervention and follow-up assessment. | Posted | Mean | Standard Deviation | Correlation coefficient | baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks |
|
Adverse event data were collected over a three-year period, corresponding from the time when the first participant was enrolled into the intervention to the time when the overall intervention ended.
We adhered to guidance provided by the Medical University of South Carolina Institutional Review Board; in order for an event to be classified as a reportable adverse event, it cannot be "the expected natural progression of any underlying disease, disorder, or condition of the subject experiencing the adverse event and the subject's predisposing risk factor profile for the adverse event". While we tracked falls, they are thus not included as adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Error Reduction | Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error reduction" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period. Error reduction: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Vascular disorders | Non-systematic Assessment | A participant was diagnosed with an acute ischemic stroke in the left middle cerebral artery while enrolled in the study. No major deficits resulted following the stroke. The participant was withdrawn from the study. |
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The overall dropout rate of this study was increased by the research shutdown with the coronavirus pandemic.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jesse Dean | Ralph H. Johnson VAMC / MUSC | 8437929566 | deaje@musc.edu |
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| 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 30, 2020 | Jun 27, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Error augmentation | Behavioral | During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke. |
|
| Activity matched control | Behavioral | During training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke. |
|
| baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks |
| Activities-specific Balance Confidence Scale (Change From Baseline) | A commonly-used clinical scale that quantifies an individual's confidence in performing various tasks requiring balance. The minimum value is 0, the maximum value is 100, and higher scores indicate a better outcome. The overall score is calculated as the mean of 16 subscores, each of which can range of 0 to 100 and represents self-efficacy at a distinct movement task. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks). | baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks |
| 10-meter Walk Test (Change From Baseline) | A commonly-used clinical test to quantify general gait function. Walking speed is measured during the middle 6-meter portion of a 10-meter straight line path. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks). | baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks |
| Fall Incidence | Self-report history of fall occurrence, quantified by the average number of falls per participant in each group during the 12-week period that followed completion of the study's intervention component | 6 months (during 12 week follow-up period) |
| Fear of Falling | Self-report statement of whether a participant has a fear of falling | 6 months (at completion of 12-week Follow-up period) |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| BG001 | Error Augmentation | Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error augmentation" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period. Error augmentation: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke. |
| BG002 | Activity Matched Control | Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "transparent" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period. Activity matched control: During training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Affected leg | Count of Participants | Participants |
|
| Time since stroke | The number of months since the participant experienced a stroke at the time of study enrollment, based on information stored in the participant database used for recruitment | Mean | Standard Deviation | months |
|
| Height | Mean | Standard Deviation | inches |
|
| Weight | Mean | Standard Deviation | pounds |
|
| Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait | This measure relates the mechanical state of the body at the start of each step (mediolateral pelvis displacement and velocity of the pelvis relative to the stance foot) to the step width at the end of the step. Specifically, the partial linear correlation between pelvis displacement and step width was calculated, accounting for variation in pelvis velocity. | Here, we present the baseline measures for only those participants who completed the intervention. | Mean | Standard Deviation | Correlation Coefficient |
|
| Functional Gait Assessment | The Functional Gait Assessment is a standardized clinical test used to assess balance during a variety of walking tasks. Possible scores range from 0 to 30, with 30 representing the best balance performance. The total possible score of 30 represents the sum of 10 possible subscores for each walking task, with each having a possible range from 0 to 3. | Here, we present the baseline measures for only those participants who completed the intervention. | Mean | Standard Deviation | Score on a scale |
|
| Activities-specific Balance Confidence scale | This measure is a common clinical assessment of balance self-efficacy during a variety of movement tasks that participants may experience in the community. Possible scores range from 0 to 100, with 100 representing the best self-efficacy. Scores are calculated as the mean of 16 subscores, each of which ranges from 0 to 100 and represents self-efficacy during a different movement task. | Here, we present the baseline measures for only those participants who completed the intervention. | Mean | Standard Deviation | Score on a scale |
|
| Walking speed (10-meter walk test) | Here, we present the baseline measures for only those participants who completed the intervention. | Mean | Standard Deviation | meters per second |
|
| Fall incidence (self reported over previous year) | Here, we present the baseline measures for only those participants who completed the intervention. | Count of Participants | Participants |
|
| Fear of falling (self-reported) | Here, we present the baseline measures for only those participants who completed the intervention. | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Error Reduction | Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error reduction" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period. Error reduction: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke. |
| OG001 | Error Augmentation | Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error augmentation" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period. Error augmentation: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke. |
| OG002 | Activity Matched Control | Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "transparent" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period. Activity matched control: During training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke. |
|
|
|
| Secondary | Functional Gait Assessment (Change From Baseline) | A commonly-used clinical test to quantify balance and stability during various walking tasks. The minimum value is 0, the maximum value is 30, and higher scores indicate better outcomes. The total maximum value of 30 is calculated as the sum of 10 subscores, each of which has a scoring range of 0-3 and represents a distinct walking task. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks). | The total of 44 participants analyzed corresponds to the participants who completed the intervention and follow-up assessment. | Posted | Mean | Standard Deviation | score on a scale | baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks |
|
|
|
|
| Secondary | Activities-specific Balance Confidence Scale (Change From Baseline) | A commonly-used clinical scale that quantifies an individual's confidence in performing various tasks requiring balance. The minimum value is 0, the maximum value is 100, and higher scores indicate a better outcome. The overall score is calculated as the mean of 16 subscores, each of which can range of 0 to 100 and represents self-efficacy at a distinct movement task. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks). | The total of 44 participants analyzed corresponds to the participants who completed the intervention and follow-up assessment. | Posted | Mean | Standard Deviation | score on a scale | baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks |
|
|
|
|
| Secondary | 10-meter Walk Test (Change From Baseline) | A commonly-used clinical test to quantify general gait function. Walking speed is measured during the middle 6-meter portion of a 10-meter straight line path. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks). | The total of 44 participants analyzed corresponds to the participants who completed the intervention and follow-up assessment. | Posted | Mean | Standard Deviation | meters per second | baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks |
|
|
|
|
| Secondary | Fall Incidence | Self-report history of fall occurrence, quantified by the average number of falls per participant in each group during the 12-week period that followed completion of the study's intervention component | The total of 44 participants analyzed corresponds to the participants who completed the intervention and follow-up assessment. | Posted | Mean | Standard Error | Falls per participant | 6 months (during 12 week follow-up period) |
|
|
|
|
| Secondary | Fear of Falling | Self-report statement of whether a participant has a fear of falling | The total of 44 participants analyzed corresponds to the participants who completed the intervention and follow-up assessment. | Posted | Count of Participants | Participants | 6 months (at completion of 12-week Follow-up period) |
|
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Error Augmentation | Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error augmentation" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period. Error augmentation: During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke. | 0 | 18 | 0 | 18 | 0 | 18 |
| EG002 | Activity Matched Control | Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "transparent" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period. Activity matched control: During training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke. | 0 | 18 | 1 | 18 | 0 | 18 |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Right leg |
|
|
| 12-week assessment |
|
| Follow-up assessment (after 12 weeks) |
|
|
| 12-week assessment |
|
| Follow-up assessment (after 12 weeks) |
|
|
| 12-week assessment |
|
| Follow-up assessment (after 12 weeks |
|