- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05113797
Use of the OPTIMAL Theory of Motor Learning With the Lower Quarter Y-Balance Test
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Lower Quarter Y-Balance Test (YBT-LQ) is used to assess dynamic balance and functional symmetry in healthy adults, athletes, and those who are rehabilitating a lower extremity injury, and has good to excellent interrater reliability. Performing the YBT-LQ requires utilization of different neuromotor and postural control strategies in each direction of the test. The OPTIMAL theory of motor learning is a theoretical framework that has been shown to improve motor performance through three main components: promotion of autonomy support (AS), presence of an external focus (EF) of attention, and implementation of enhanced expectancies (EE) placed upon a task. These components of the OPTIMAL theory of motor learning have been demonstrated to enhance balance learning in several populations. There is also extensive literature on the effects of the individual components of the OPTIMAL theory of motor learning and some evidence that demonstrates the beneficial effects of the combined components on motor learning. However, to the authors knowledge, literature has not been published upon the effect of all three components of the OPTIMAL theory of motor learning on dynamic balance learning. Therefore, the purpose of this study is intended to determine if the OPTIMAL theory of motor learning will influence performance on the YBT-LQ.
Healthy participants aged 18 to 65 will be recruited for participation through word-of-mouth advertising. Inclusion criteria will include a passing score of >35 degrees bilateral ankle dorsiflexion and an ability to balance on one leg. Upon signing the informed consent document from participants, height, weight, BMI, gender, age, and limb length will be recorded for data analysis. Participants will be randomly assigned to one of two groups: an OPTIMAL motor learning group or a control group. The intended experimental design will be a multigroup nonequivalent pretest-posttest control group for this study. Participants will attend two study visits separated by 2-14 days. A visit one baseline YBT-LQ pretest will be administered in a standardized fashion the same for both groups. During visit two, the OPTIMAL group will practice the YBT-LQ using OPTIMAL principles, while the control group practices the YBT-LQ using standard principles, then both groups will undergo a posttest YBT-LQ measurement. Primary outcome measures will be normalized composite scores of the YBT-LQ. Secondary outcome measures will be participant self-reported measures of perceived competence, task effort, level of autonomy, and externally focused attention during the task on a 0 to 10 Likert scale.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55904
- Darren Calley
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy participants
- Having the ability to safely stand on one leg and pass the ankle dorsiflexion clearing test (> 35 degrees ankle dorsiflexion).
Exclusion Criteria:
- Presence of a recent lower extremity injury in the last month that limits their ability to stand on one leg.
- Failure to achieve 35 degrees of bilateral dorsiflexion on the dorsiflexion clearing test.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Control Group
Subjects will perform YBT-LQ practice tests using standardized set of verbal instructions provided in the YBT-LQ online manual prior to the testing condition.
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Dynamic balance assessment performed in a standing position while balanced on one leg, participants are asked to move a plastic box with their other foot in three directions (forward, back to the left, and back to the right) and a distance measurement is recorded.
Each leg will be tested three times in each direction for the YBT-LQ assessment.
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EXPERIMENTAL: OPTIMAL Motor Learning Group
Subjects will perform the YBT-LQ with the practice period altered to implement aspects of the three pillars of the OPTIMAL motor learning theory (promotion of autonomy support (AS), presence of an external focus (EF) of attention, and implementation of enhanced expectancies (EE) placed upon a task).
|
Dynamic balance assessment performed in a standing position while balanced on one leg, participants are asked to move a plastic box with their other foot in three directions (forward, back to the left, and back to the right) and a distance measurement is recorded.
Each leg will be tested three times in each direction for the YBT-LQ assessment.
OPTIMAL theoretical framework instructions and coaching will be utilized to improve motor performance through three main components: promotion of autonomy support (AS), presence of an external focus (EF) of attention, and implementation of enhanced expectancies (EE) placed upon a task.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in composite YBT-LQ scores
Time Frame: Baseline, 14 days
|
Measure by 3 reach trials in 3 directions on each leg recorded to the nearest 0.5 cm.
Composite score calculated by the sum of three directions for one leg divided by three times limb length, multiplied by 100
|
Baseline, 14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived competence
Time Frame: 14 days
|
Measured using a self-reported Likert scale that rates their level of agreement to the statement, "I had the ability and understanding to move the box as far as possible in all three directions (anterior, posteromedial, and posterolateral)" on a scale of 0=strongly disagree, 5=neutral, and 10=strongly agree
|
14 days
|
|
Task Effort
Time Frame: 14 days
|
Measured using a self-reported Likert scale that rates their level of agreement to the statement, "I tried very hard on this balance test" on a scale of 0=strongly disagree, 5=neutral, and 10=strongly agree
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14 days
|
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Level of autonomy
Time Frame: 14 days
|
Measured using a self-reported Likert scale that rates their level of agreement to the statement, "I felt in control of my ability to perform well on the Lower Quarter Y-Balance Test" on a scale of 0=strongly disagree, 5=neutral, and 10=strongly agree
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14 days
|
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Externally focused attention during the task
Time Frame: 14 days
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Measured using a self-reported Likert scale that rates their level of agreement to the statement, "I focused on the target more than myself pushing the box during the test" on a scale of 0=strongly disagree, 5=neutral, and 10=strongly agree
|
14 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Darren Calley, PT, DScPT, OCS, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 21-009316
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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