Muscle WeaknessNCT06445491
Effect of Sequencing on Outcome Measures
A study testing Randomized sequence in people with Muscle Weakness, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
Trial summary
This pilot study will examine the effect of testing order on test outcomes for measures of strength, dynamic balance, and movement quality. Each participant will perform a baseline test, then will perform the 6 iterations of the testing sequence. Read more about this study
- Who is it for?
- Ages 18 to 57 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- Randomized sequence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2024to 15 Oct 2024
- 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 57 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy adult by Physical Activity Readiness Questionnaire+ screening process
Who cannot join
- lower extremity or spine injury in past 6 months
- vestibular disorder
- known pregnancy
- inability to complete data collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Test Order of Isokinetic Torque, Y-Balance/Firefighter-Specific Functional-Balance, and Forward-Step-Down on Test Performance: Identifying Optimal Sequences
This pilot study will examine the effect of testing order on test outcomes for measures of strength, dynamic balance, and movement quality. Each participant will perform a baseline test, then will perform the 6 iterations of the testing sequence.
Read the detailed description
This study employs a Repeated Measures Design, with each participant tested multiple times in combinations of 1) the Isokinetic Torque Test, 2) the Y-Balance Test/Firefighter-Specific Functional-Balance Test, and 3) the Forward-Step-Down Test. The investigators will conduct a total of seven testing sessions, including a control session (informed consent, familiarization with outcome measures, and control data collection) and the following six different patterns: 1-2-3, 1-3-2, 2-1-3, 2-3-1, 3-1-2, and 3-2-1. The order of the sessions will be randomized and counterbalanced to prevent bias effects. The control session will be performed in the following order: (1) Forward-Step-Down Test, (2a) Firefighter Specific Functional Balance Test, (2b) Y-balance test, (3) isokinetic tests (hip then knee).
Participants will be asked to avoid exercise or vigorous physical activity for the 24 hours prior to any testing session to minimize the effects of non-test-related fatigue on the study outcomes. Pre and post-test fatigue will be measured with the Rating of Fatigue (ROF) Scale. Pre-and post-test exertion will be measured with the Borg Rating of Perceived Exertion (RPE) Scale (attached). Heartrate will be measured and recorded at each scale rating point.
Upon arrival for the control session, participants will have their height measured using a stadiometer and their weight recorded. This will be followed by the performance of the initial 1-2-3 pattern. The time needed for the participant to perform each test will be recorded and subsequent performances of that test will be carried out in this time frame.
For visits two through seven, participants will be weighed again upon arrival and perform one of the six patterns. Sessions two to seven will be separated by at least one day to minimize the influence of fatigue. Each session will include isokinetic torque measurements of the hip abductors and adductors, knee flexors and extensors, the Y-Balance Test, the Firefighter-Specific Functional-Balance Test, and the Forward-Step-Down Test. The dominant leg will be used for unilateral tests, as determined by the leg used to kick a ball. The order of outcome measures will be randomized for each participant to minimize the effects of fatigue and recovery.
Five minutes of warm-up on a stationary bike or walking will be performed to start each exercise session. Five minutes of rest and instruction will be provided between each outcome measure. Five minutes of rest will be given between isokinetic tests (hip abduction to adduction) to allow for machine set-up and instructions. One minute of rest will be given between each isokinetic speed, with three speeds tested for the hip (30°, 60°, and 120° per second) and knee (60°, 180°, and 300° per second) muscles.
- Conditions
- Muscle Weakness
- Being tested
- Control order, Randomized sequence
- Keywords
- strength, dynamic balance, movement quality, injury prevention
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control orderOther
Participants will perform an initial baseline of tests, order of 1- 2- 3
Randomized sequenceOther
the testing order will be randomized for follow up testing.
| Study group | Role | What they receive |
|---|---|---|
| control trial | Active comparator | Testing order: (1) forward step down test, (2) firefighter specific functional balance test \& y-balance test, (3) hip isokinetic strength \& knee isokinetic strength Receives: Other: Control order |
| sequenced trials | Experimental | Participants will perform the following variations on testing order over 6 separate sessions: 1-2-3, 1-3-2, 2-1-3, 2-3-1, 3-1-2, and 3-2-1 Receives: Other: Randomized sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forward-Step-Down Test
a step-down task that is performed off a 20 cm box. Five repetitions are performed to give one score (minimum score 0, maximum score 6). A higher score is worse.
Measured: This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
Firefighter Specific Functional Balance Test
A dynamic balance test performed by stepping down from a 15cm box, walking across a low beam (4cm high), and stepping up onto a 10cm box, turning around, and returning to the original box. 8 Trials are performed. In 4 trials, a bar is placed at 75% of the participant's height for them to negotiate while on the beam. A faster time with fewer errors is better.
Measured: This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
Y-Balance Test
A dynamic balance test that is performed on the dominant leg, reaching in the anterior, posteromedial, and posterolateral directions. The length of reach is standardized to participants' leg length. A higher score is better.
Measured: This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
Knee Extensor Isokinetic Test
Knee extensor isokinetic strength will be tested at 60°, 180°, and 300° per second from the seated position with 5, 10, and 10 concentric contractions for each speed. A higher reading of strength is better.
Measured: This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
Hip Abductor Isokinetic Test
Hip abductor strength will be tested at 30°, 60°, and 120° per second from the standing position. A higher reading of strength is better.
Measured: This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
Secondary outcomes (3)
Rating of Fatigue
A score from 0-10 will be provided before and after each test category (strength, balance, movement quality). A higher score indicated more fatigue.
Measured: This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
Rating of Perceived Exertion
A score from 6-20 will be provided before and after each test category (strength, balance, movement quality). A higher score indicated more perceived exertion.
Measured: This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
Heartrate
heartrate will be recorded as a measure of physiological effort and for participant safety.
Measured: This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start23 Jul 2024
- Primary completion30 Sep 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants will receive all 6 iterations of testing order, but the order of test sequences will be randomized.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center Shreveport
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin McCallister, DPT, Principal investigator, LSUHSC-Shreveport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445491
- Sponsor's protocol ID
- STUDY00002716
- Status last verified
- Dec 2024
- First submitted
- 22 May 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gagge AP, Stolwijk JA, Hardy JD. Comfort and thermal sensations and associated physiological responses at various ambient temperatures. Environ Res. 1967 Jun;1(1):1-20. doi: 10.1016/0013-9351(67)90002-3. No abstract available.
PubMed 5614624Games KE, Winkelmann ZK, McGinnis KD, McAdam JS, Pascoe DD, Sefton JM. Functional Performance of Firefighters After Exposure to Environmental Conditions and Exercise. J Athl Train. 2020 Jan;55(1):71-79. doi: 10.4085/1062-6050-75-18. Epub 2019 Dec 26.
PubMed 31876454Hewett TE, Ford KR, Hoogenboom BJ, Myer GD. Understanding and preventing acl injuries: current biomechanical and epidemiologic considerations - update 2010. N Am J Sports Phys Ther. 2010 Dec;5(4):234-51.
PubMed 21655382Lopes TJA, Simic M, Myer GD, Ford KR, Hewett TE, Pappas E. The Effects of Injury Prevention Programs on the Biomechanics of Landing Tasks: A Systematic Review With Meta-analysis. Am J Sports Med. 2018 May;46(6):1492-1499. doi: 10.1177/0363546517716930. Epub 2017 Jul 31.
PubMed 28759729Nascimento LR, Teixeira-Salmela LF, Souza RB, Resende RA. Hip and Knee Strengthening Is More Effective Than Knee Strengthening Alone for Reducing Pain and Improving Activity in Individuals With Patellofemoral Pain: A Systematic Review With Meta-analysis. J Orthop Sports Phys Ther. 2018 Jan;48(1):19-31. doi: 10.2519/jospt.2018.7365. Epub 2017 Oct 15.
PubMed 29034800Park KM, Cynn HS, Choung SD. Musculoskeletal predictors of movement quality for the forward step-down test in asymptomatic women. J Orthop Sports Phys Ther. 2013;43(7):504-10. doi: 10.2519/jospt.2013.4073. Epub 2013 Jun 11.
PubMed 23756380McCallister, E., & Flowers, D. W. (2020). Can the Forward-Step-Down Test Be Used Reliably in the Clinical Setting to Assess Movement Changes Resulting from Maximal Exertion? A Pilot Study. Internet Journal of Allied Health Sciences and Practice, 18(4).
Powers CM. The influence of abnormal hip mechanics on knee injury: a biomechanical perspective. J Orthop Sports Phys Ther. 2010 Feb;40(2):42-51. doi: 10.2519/jospt.2010.3337.
PubMed 20118526van Melick N, Meddeler BM, Hoogeboom TJ, Nijhuis-van der Sanden MWG, van Cingel REH. How to determine leg dominance: The agreement between self-reported and observed performance in healthy adults. PLoS One. 2017 Dec 29;12(12):e0189876. doi: 10.1371/journal.pone.0189876. eCollection 2017.
PubMed 29287067Brent JL, Myer GD, Ford KR, Paterno MV, Hewett TE. The effect of sex and age on isokinetic hip-abduction torques. J Sport Rehabil. 2013 Feb;22(1):41-6. doi: 10.1123/jsr.22.1.41. Epub 2012 Jun 18.
PubMed 22715125Claiborne TL, Timmons MK, Pincivero DM. Test-retest reliability of cardinal plane isokinetic hip torque and EMG. J Electromyogr Kinesiol. 2009 Oct;19(5):e345-52. doi: 10.1016/j.jelekin.2008.07.005. Epub 2008 Oct 8.
PubMed 18845450Gokeler A, Welling W, Zaffagnini S, Seil R, Padua D. Development of a test battery to enhance safe return to sports after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2017 Jan;25(1):192-199. doi: 10.1007/s00167-016-4246-3. Epub 2016 Jul 16.
PubMed 27423208
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Test Order of Isokinetic Torque, Y-Balance/Firefighter-Specific Functional-Balance, and Forward-Step-Down on Test Performance: Identifying Optimal Sequences
- ClinicalTrials.gov ID
- NCT06445491
- Acronym / sponsor ID
- STUDY00002716
- Conditions
- Muscle Weakness
- Keywords
- strength, dynamic balance, movement quality, injury prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center ShreveportUniversity, hospital or other
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 6 Jun 2024 (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.
This pilot study will examine the effect of testing order on test outcomes for measures of strength, dynamic balance, and movement quality. Each participant will perform a baseline test, then will perform the 6 iterations of the testing sequence.
Detailed description
This study employs a Repeated Measures Design, with each participant tested multiple times in combinations of 1) the Isokinetic Torque Test, 2) the Y-Balance Test/Firefighter-Specific Functional-Balance Test, and 3) the Forward-Step-Down Test. The investigators will conduct a total of seven testing sessions, including a control session (informed consent, familiarization with outcome measures, and control data collection) and the following six different patterns: 1-2-3, 1-3-2, 2-1-3, 2-3-1, 3-1-2, and 3-2-1. The order of the sessions will be randomized and counterbalanced to prevent bias effects. The control session will be performed in the following order: (1) Forward-Step-Down Test, (2a) Firefighter Specific Functional Balance Test, (2b) Y-balance test, (3) isokinetic tests (hip then knee).
Participants will be asked to avoid exercise or vigorous physical activity for the 24 hours prior to any testing session to minimize the effects of non-test-related fatigue on the study outcomes. Pre and post-test fatigue will be measured with the Rating of Fatigue (ROF) Scale. Pre-and post-test exertion will be measured with the Borg Rating of Perceived Exertion (RPE) Scale (attached). Heartrate will be measured and recorded at each scale rating point.
Upon arrival for the control session, participants will have their height measured using a stadiometer and their weight recorded. This will be followed by the performance of the initial 1-2-3 pattern. The time needed for the participant to perform each test will be recorded and subsequent performances of that test will be carried out in this time frame.
For visits two through seven, participants will be weighed again upon arrival and perform one of the six patterns. Sessions two to seven will be separated by at least one day to minimize the influence of fatigue. Each session will include isokinetic torque measurements of the hip abductors and adductors, knee flexors and extensors, the Y-Balance Test, the Firefighter-Specific Functional-Balance Test, and the Forward-Step-Down Test. The dominant leg will be used for unilateral tests, as determined by the leg used to kick a ball. The order of outcome measures will be randomized for each participant to minimize the effects of fatigue and recovery.
Five minutes of warm-up on a stationary bike or walking will be performed to start each exercise session. Five minutes of rest and instruction will be provided between each outcome measure. Five minutes of rest will be given between isokinetic tests (hip abduction to adduction) to allow for machine set-up and instructions. One minute of rest will be given between each isokinetic speed, with three speeds tested for the hip (30°, 60°, and 120° per second) and knee (60°, 180°, and 300° per second) muscles.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants will receive all 6 iterations of testing order, but the order of test sequences will be randomized.
| Arm | Type | Receives |
|---|---|---|
| control trial | Active comparator | Other: Control orderTesting order: (1) forward step down test, (2) firefighter specific functional balance test \& y-balance test, (3) hip isokinetic strength \& knee isokinetic strength |
| sequenced trials | Experimental | Other: Randomized sequenceParticipants will perform the following variations on testing order over 6 separate sessions: 1-2-3, 1-3-2, 2-1-3, 2-3-1, 3-1-2, and 3-2-1 |
Who may qualify
- Ages
- 18 to 57 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy adult by Physical Activity Readiness Questionnaire+ screening process
Key exclusion criteria (4 listed)
- lower extremity or spine injury in past 6 months
- vestibular disorder
- known pregnancy
- inability to complete data collection
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 |
|---|---|---|
| Control orderParticipants will perform an initial baseline of tests, order of 1- 2- 3 | Other | control trial |
| Randomized sequencethe testing order will be randomized for follow up testing. | Other | sequenced trials |
Primary outcome
Forward-Step-Down Test
Time frame: This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
a step-down task that is performed off a 20 cm box. Five repetitions are performed to give one score (minimum score 0, maximum score 6). A higher score is worse.
Firefighter Specific Functional Balance Test
Time frame: This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
A dynamic balance test performed by stepping down from a 15cm box, walking across a low beam (4cm high), and stepping up onto a 10cm box, turning around, and returning to the original box. 8 Trials are performed. In 4 trials, a bar is placed at 75% of the participant's height for them to negotiate while on the beam. A faster time with fewer errors is better.
Y-Balance Test
Time frame: This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
A dynamic balance test that is performed on the dominant leg, reaching in the anterior, posteromedial, and posterolateral directions. The length of reach is standardized to participants' leg length. A higher score is better.
Knee Extensor Isokinetic Test
Time frame: This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
Knee extensor isokinetic strength will be tested at 60°, 180°, and 300° per second from the seated position with 5, 10, and 10 concentric contractions for each speed. A higher reading of strength is better.
Hip Abductor Isokinetic Test
Time frame: This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
Hip abductor strength will be tested at 30°, 60°, and 120° per second from the standing position. A higher reading of strength is better.
3 secondary outcomes
Rating of Fatigue
Time frame: This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
Rating of Perceived Exertion
Time frame: This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
Heartrate
Time frame: This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
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 13 Dec 2024.
- Background: PubMed 5614624Gagge AP, Stolwijk JA, Hardy JD. Comfort and thermal sensations and associated physiological responses at various ambient temperatures. Environ Res. 1967 Jun;1(1):1-20. doi: 10.1016/0013-9351(67)90002-3. No abstract available.
- Background: PubMed 31876454Games KE, Winkelmann ZK, McGinnis KD, McAdam JS, Pascoe DD, Sefton JM. Functional Performance of Firefighters After Exposure to Environmental Conditions and Exercise. J Athl Train. 2020 Jan;55(1):71-79. doi: 10.4085/1062-6050-75-18. Epub 2019 Dec 26.
- Background: PubMed 21655382Hewett TE, Ford KR, Hoogenboom BJ, Myer GD. Understanding and preventing acl injuries: current biomechanical and epidemiologic considerations - update 2010. N Am J Sports Phys Ther. 2010 Dec;5(4):234-51.
- Background: PubMed 28759729Lopes TJA, Simic M, Myer GD, Ford KR, Hewett TE, Pappas E. The Effects of Injury Prevention Programs on the Biomechanics of Landing Tasks: A Systematic Review With Meta-analysis. Am J Sports Med. 2018 May;46(6):1492-1499. doi: 10.1177/0363546517716930. Epub 2017 Jul 31.
- Background: PubMed 29034800Nascimento LR, Teixeira-Salmela LF, Souza RB, Resende RA. Hip and Knee Strengthening Is More Effective Than Knee Strengthening Alone for Reducing Pain and Improving Activity in Individuals With Patellofemoral Pain: A Systematic Review With Meta-analysis. J Orthop Sports Phys Ther. 2018 Jan;48(1):19-31. doi: 10.2519/jospt.2018.7365. Epub 2017 Oct 15.
- Background: PubMed 23756380Park KM, Cynn HS, Choung SD. Musculoskeletal predictors of movement quality for the forward step-down test in asymptomatic women. J Orthop Sports Phys Ther. 2013;43(7):504-10. doi: 10.2519/jospt.2013.4073. Epub 2013 Jun 11.
- BackgroundMcCallister, E., & Flowers, D. W. (2020). Can the Forward-Step-Down Test Be Used Reliably in the Clinical Setting to Assess Movement Changes Resulting from Maximal Exertion? A Pilot Study. Internet Journal of Allied Health Sciences and Practice, 18(4).
- Background: PubMed 20118526Powers CM. The influence of abnormal hip mechanics on knee injury: a biomechanical perspective. J Orthop Sports Phys Ther. 2010 Feb;40(2):42-51. doi: 10.2519/jospt.2010.3337.
- Background: PubMed 29287067van Melick N, Meddeler BM, Hoogeboom TJ, Nijhuis-van der Sanden MWG, van Cingel REH. How to determine leg dominance: The agreement between self-reported and observed performance in healthy adults. PLoS One. 2017 Dec 29;12(12):e0189876. doi: 10.1371/journal.pone.0189876. eCollection 2017.
- Background: PubMed 22715125Brent JL, Myer GD, Ford KR, Paterno MV, Hewett TE. The effect of sex and age on isokinetic hip-abduction torques. J Sport Rehabil. 2013 Feb;22(1):41-6. doi: 10.1123/jsr.22.1.41. Epub 2012 Jun 18.
- Background: PubMed 18845450Claiborne TL, Timmons MK, Pincivero DM. Test-retest reliability of cardinal plane isokinetic hip torque and EMG. J Electromyogr Kinesiol. 2009 Oct;19(5):e345-52. doi: 10.1016/j.jelekin.2008.07.005. Epub 2008 Oct 8.
- Background: PubMed 27423208Gokeler A, Welling W, Zaffagnini S, Seil R, Padua D. Development of a test battery to enhance safe return to sports after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2017 Jan;25(1):192-199. doi: 10.1007/s00167-016-4246-3. Epub 2016 Jul 16.
- Individual participant dataSharing planned: No
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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.
Erin McCallister, DPT principal investigator
LSUHSC-Shreveport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Randomized sequence in people with Muscle Weakness, run by Louisiana State University Health Sciences Center Shreveport 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 1 inclusion and 4 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 13 Dec 2024. 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?
Forward-Step-Down Test (time frame: This outcome will be assessed at each visit throughout the study, an average of 6 weeks.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06445491, which also lists 12 linked publications.
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 13 Dec 2024; AzTrials last refreshed its copy on 1 Nov 2026.