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| Name | Class |
|---|---|
| TriHealth Inc. | OTHER |
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The purpose of this study is to systematically determine the effect of unnecessary physical therapist assistance in individuals after stroke during the practice of an upper limb task on an individual's task performance and their underlying motor control patterns when learning (or re-learning) motor skills.
Independent motor task performance is the most highly prioritized outcome of physical therapy for individuals with motor disability. Accordingly, a key priority for physical therapists in multiple practice settings is the advancement of functional motor independence. Therapists must determine when a patient requires assistance (e.g., verbal cues, physical support) to complete a motor task and when a patient is able to execute a motor skill with less assistance. If a therapist does not provide enough support, the patient is at risk for unsuccessful task performance. As such, therapists often default to providing a higher level of assistance.
An individual following stroke, for instance, may demonstrate an increased magnitude of postural sway while completing self-care activities at the sink. A therapist may decide to provide physical support for the patient to decrease sway variability, whether or not the patient requires this support to maintain performance. The motor control consequences of providing this assistance (thus constraining movement variability and providing fewer options for adapting movement) when assistance is actually not needed is unknown. The purpose of this study is to systematically determine the effect of unnecessary assistance during the practice of an upper limb task on functional performance and underlying motor control patterns when learning (or re-learning) motor skills in individuals with stroke. The insights gained from the current project will have the potential to improve the currently available physical therapy interventions for individuals with stroke.
The effects of unnecessary physical therapist support will be examined in terms of upper limb task performance, retention, and transfer, and in terms of the postural control supporting task performance. The study is currently planned for individuals with stroke. Participants will be required to maintain the position of a virtual laser within a target while standing. An experimental group will receive postural support (physical assistance to maintain upright posture) during a practice period in order to specifically determine the effect of postural support on upper limb task performance and postural sway patterns. Participants will also engage in a light finger force production transfer task to ascertain the influence of postural support on a different supra-postural task.
It is hypothesized that providing unnecessary assistance (and thus limiting independence) during practice of a novel motor task will result in (a) faster improvements in task performance but reduced retention and more limited transfer to another, similar task; and (b) reduced task- sensitive postural sway adjustments (measured in terms of both the quantity and temporal structure) during practice, at transfer, and at retention, reflecting reduced adaptability of postural patterns to task demands.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Participants will receive physical therapist support to reduce postural sway while completing a precision aiming task in virtual reality, whether or not they require the support. |
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| Control Group | No Intervention | Participants will receive no physical therapist support while completing the task. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical therapist support | Behavioral | Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality. |
| Measure | Description | Time Frame |
|---|---|---|
| Center of Pressure Path Length | The amount of displacement of the location of the (resultant) vertical ground reaction force vector. Results only presented as the mean difference between groups, as only the paretic limb was used for this portion of the study. There are no results to report for the non-paretic limb. | 10 minutes of practice |
| Standard Deviation of Center of Pressure | Variability of center of pressure trajectory. | After 10 minutes of practice |
| Percent Determinism of Postural Sway | Quantifies the patterning, non-stationarity, and complexity of biological time series through the analysis of local recurrences in a reconstructed phase space. Highter values of percent determinism indicate more regularity in postural sway. | After 10 minutes of practice |
| Entropy (Sample Entropy) | Evaluates the predictability of the next state of a system, given what is known about the current state of a system. Higher values of SampEn indicate less regularity; lower values indicate more regularity. Outcome measure reported as a ratio of anterior-posterior to medial-lateral SampEn values. | After 10 minutes of practice |
| Percent Correct | Percent time on target. | After 10 minutes of practice |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati Center for Cognition, Action, and Perception | Cincinnati | Ohio | 45221 | United States |
Analytic code and other study materials may be shared on PI's Open Science Framework (OSF) page.
Within 6 months of study completion or after the primary manuscript from this study is accepted for publication and will likely remain available indefinitely
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Group | Participants will receive physical therapist support to reduce postural sway while completing a precision aiming task in virtual reality, whether or not they require the support. Physical therapist support: Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality. |
| FG001 | Control Group | Participants will receive no physical therapist support while completing the task. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Group | Participants will receive physical therapist support to reduce postural sway while completing a precision aiming task in virtual reality, whether or not they require the support. Physical therapist support: Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Center of Pressure Path Length | The amount of displacement of the location of the (resultant) vertical ground reaction force vector. Results only presented as the mean difference between groups, as only the paretic limb was used for this portion of the study. There are no results to report for the non-paretic limb. | Difference between path length during practice. | Posted | Mean | Standard Error | cm^2 | 10 minutes of practice |
|
No adverse events occurred during the study (1 hour, single session). Participants were only assessed for adverse events during the 1-hour single session
There was no risk of death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect by participating in this study.
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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 | Experimental Group | Participants will receive physical therapist support to reduce postural sway while completing a precision aiming task in virtual reality, whether or not they require the support. Physical therapist support: Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Schwab | University of Cincinnati | 5135587477 | schwabsr@mail.uc.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 | Oct 7, 2021 | Oct 5, 2022 | 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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| BG001 | Control Group | Participants will receive no physical therapist support while completing the task. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | Control Group | Participants will receive no physical therapist support while completing the task. |
|
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| Primary | Standard Deviation of Center of Pressure | Variability of center of pressure trajectory. | Post-test results from when participants were aiming with each upper limb. | Posted | Mean | Standard Error | cm | After 10 minutes of practice |
|
|
|
| Primary | Percent Determinism of Postural Sway | Quantifies the patterning, non-stationarity, and complexity of biological time series through the analysis of local recurrences in a reconstructed phase space. Highter values of percent determinism indicate more regularity in postural sway. | Post-test results | Posted | Mean | Standard Error | percent determinism | After 10 minutes of practice |
|
|
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| Primary | Entropy (Sample Entropy) | Evaluates the predictability of the next state of a system, given what is known about the current state of a system. Higher values of SampEn indicate less regularity; lower values indicate more regularity. Outcome measure reported as a ratio of anterior-posterior to medial-lateral SampEn values. | Post-test results | Posted | Mean | Standard Error | ratio of AP:ML | After 10 minutes of practice |
|
|
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| Primary | Percent Correct | Percent time on target. | Post-test results | Posted | Mean | Standard Error | percentage of time on target | After 10 minutes of practice |
|
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| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Control Group | Participants will receive no physical therapist support while completing the task. | 0 | 12 | 0 | 12 | 0 | 12 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |