BalanceNCT05113797
Use of the OPTIMAL Theory of Motor Learning With the Lower Quarter Y-Balance Test
A study testing Lower Quarter Y-Balance Test and OPTIMAL motor learning theory in people with Balance, run by Mayo Clinic at 1 site in United States.
Trial summary
Assessing and improving movement quality are important components of rehabilitation. The Lower Quarter Y-Balance Test (YBT-LQ) is a balance test used to assess dynamic balance in healthy adults, athletes, and those who are rehabilitating a lower extremity injury. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Balance
- What is being tested?
- Lower Quarter Y-Balance Test and OPTIMAL motor learning theory
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2021to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy participants
- Having the ability to safely stand on one leg and pass the ankle dorsiflexion clearing test (> 35 degrees ankle dorsiflexion).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Assessing and improving movement quality are important components of rehabilitation. The Lower Quarter Y-Balance Test (YBT-LQ) is a balance test used to assess dynamic balance in healthy adults, athletes, and those who are rehabilitating a lower extremity injury. Performing the YBT-LQ requires utilization of different strategies. It is unknown how different practice conditions will affect dynamic balance learning or performance on YBT-LQ. This study aims to compare the influence of OPTIMAL motor learning practice with standard practice conditions on YBT-LQ measurements.
Read the 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.
- Conditions
- Balance
- Being tested
- Lower Quarter Y-Balance Test, OPTIMAL motor learning theory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower Quarter Y-Balance TestDiagnostic test
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 motor learning theoryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | 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. Receives: Diagnostic Test: Lower Quarter Y-Balance Test |
| OPTIMAL Motor Learning Group | Experimental | 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). Receives: Diagnostic Test: Lower Quarter Y-Balance Test; Behavioral: OPTIMAL motor learning theory |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in composite YBT-LQ scores
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
Measured: Baseline, 14 days
Secondary outcomes (4)
Perceived competence
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
Measured: 14 days
Task Effort
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
Measured: 14 days
Level of autonomy
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
Measured: 14 days
Externally focused attention during the task
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
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start13 Nov 2021
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BalanceStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darren Q. Calley, Mayo Clinic
- Investigators
- Darren Calley, PT, DScPT, OCS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113797
- Sponsor's protocol ID
- 21-009316
- Status last verified
- Aug 2022
- First submitted
- 2 Nov 2021
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the OPTIMAL Theory of Motor Learning With the Lower Quarter Y-Balance Test
- ClinicalTrials.gov ID
- NCT05113797
- Acronym / sponsor ID
- 21-009316
- Conditions
- Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 13 Nov 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessing and improving movement quality are important components of rehabilitation. The Lower Quarter Y-Balance Test (YBT-LQ) is a balance test used to assess dynamic balance in healthy adults, athletes, and those who are rehabilitating a lower extremity injury. Performing the YBT-LQ requires utilization of different strategies. It is unknown how different practice conditions will affect dynamic balance learning or performance on YBT-LQ. This study aims to compare the influence of OPTIMAL motor learning practice with standard practice conditions on YBT-LQ measurements.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Diagnostic Test: Lower Quarter Y-Balance TestSubjects will perform YBT-LQ practice tests using standardized set of verbal instructions provided in the YBT-LQ online manual prior to the testing condition. |
| OPTIMAL Motor Learning Group | Experimental | Diagnostic Test: Lower Quarter Y-Balance Test, Behavioral: OPTIMAL motor learning theorySubjects 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy participants
- Having the ability to safely stand on one leg and pass the ankle dorsiflexion clearing test (> 35 degrees ankle dorsiflexion).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lower Quarter Y-Balance TestDynamic 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. | Diagnostic test | Control Group, OPTIMAL Motor Learning Group |
| OPTIMAL motor learning theoryOPTIMAL 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. | Behavioural | OPTIMAL Motor Learning Group |
Primary outcome
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
4 secondary outcomes
Perceived competence
Time frame: 14 days
Task Effort
Time frame: 14 days
Level of autonomy
Time frame: 14 days
Externally focused attention during the task
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren Calley, PT, DScPT, OCS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower Quarter Y-Balance Test and OPTIMAL motor learning theory in people with Balance, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in composite YBT-LQ scores (time frame: Baseline, 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.