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Scapular DyskinesisExperimentalNCT07504653

Game-Based Rehab for Scapular Dyskinesia

A study testing game based mobile application scapular stabilisation exercises and Postural correction exercises in people with Scapular Dyskinesis, run by INTI International University at 1 site in Malaysia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Scapular dyskinesia (SD) is a disorder defined by aberrant scapular placement and movement, which can have a substantial impact on athletes' performance, particularly those who participate in throwing sports like Frisbee. Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Scapular Dyskinesis
What is being tested?
game based mobile application scapular stabilisation exercises and Postural correction exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteMalaysia
Study dates
Apr 2026to Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • must be competitive Frisbee players .
  • should engage in regular training sessions lasting 1.5 to 2 hours per session, with a minimum of one session per week.
  • required to have a full range of motion in the Glenohumeral joint.
  • Diagnosed to have Scapular dyskinesia thr0ugh LSST.

Who cannot join

  • recreational Frisbee players.
  • any recent head or neck injuries within the past three months or any upper body surgery in the past year.
  • Acute fractures in the shoulder girdle, spine, or thoracic cage.
  • history of Chronic Obstructive Pulmonary Disease (COPD), uncontrolled asthma, pulmonary infectious diseases, or respiratory tract infectious diseases.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

NITHIYAH MARUTHEY, Master of Physiotherapy contact

+60162015371

nithiyah.maruthey@newinti.edu.my

Rajermani Thinakaran Thinakaran, Phd In IT contact

0163128595

rajermani.thina@newinti.edu.my

Malaysia1 site, 1 recruiting
  • Inti International University

    Seremban, Negeri Sembilan, 71800

    NITHIYAH MARUTHEY, Master in physiotherapy, 0162015371, nithiyah.maruthey@newinti.edu.my

    nithiyahmaruthey@gmail.com

    Recruiting

Other trials in Malaysia

About this study

Official title: Game-Based Rehabilitation for Scapular Dyskinesia Among Frisbee Players

Scapular dyskinesia (SD) is a disorder defined by aberrant scapular placement and movement, which can have a substantial impact on athletes' performance, particularly those who participate in throwing sports like Frisbee. This study aims to investigate the prevalence of SD among Frisbee players in Malaysia, assess its effects on various aspects of athletic performance, and evaluate the effectiveness of gamified scapular rehabilitation exercises delivered via a mobile application. This study's approach is divided into three unique phases, where phase one consists of a prevalence and impact assessment using a cross-sectional study design, which will be carried out among several Frisbee clubs in Malaysia. This phase will use several outcome measures to evaluate SD and its impact along with respiratory muscle strength assessments to analyze the potential respiratory outcomes. Phase Two focuses on the creation of a mobile application that would gamify scapular rehabilitation exercises while embracing agile development approaches. The development process will include comprehensive testing procedures to ensure functionality and usability, such as functional testing to verify the application's features, usability testing to assess user experience, data validation to ensure accurate information processing, and regression testing to confirm stability after updates, and user acceptance testing to evaluate performance in real-world scenarios. Phase Three consists of intervention and evaluation by a randomized controlled trial (RCT) to determine the efficacy of the gamified rehabilitation intervention. The intervention, which consists of gamified scapular rehabilitation exercises given via a mobile application, will last eight weeks. Subjects will be followed up after 6 months of the intervention to determine their level of adherence to the rehabilitation.The expected outcomes of this study aim to significantly contribute to the field of sports medicine and rehabilitation by introducing and validating gamified rehabilitation techniques specifically designed for athletes with scapular dyskinesia. The study results are expected to promote the well-being of athletes by improving their sports performance and reducing the risk of injuries. In conclusion, this study not only advances our understanding of SD in athletes but also paves the way for innovative rehabilitation solutions that can be adopted across various sports and settings.

Read the detailed description

2.1 Study Design The study design follows a structured approach comprising three key phases where phase one assesses the prevalence and impact of SD on Frisbee players. Meanwhile, phase two focuses on developing mobile game incorporating scapular stabilization exercises. Lastly, phase three will evaluate the effectiveness of the gamified rehabilitation and the adherence level.

2.1.1 Phase One: Prevalence and Impact Assessment In the first phase of the study, a cross-sectional design will be employed to determine the prevalence and impact of SD among competitive Frisbee players in Malaysia. This approach will allow researchers to measure the prevalence and explore associations between variables at a specific point in time. The study will be conducted across various Frisbee clubs in Malaysia to ensure a representative sample of the target population. The participants will consist of competitive Frisbee players who have been diagnosed with SD, with a calculated sample size of 235 participants, determined using GPOWER 3.1 software, to provide statistical power and reliable prevalence estimates. The primary outcome measures include the Lateral Scapular Slide Test (LSST) for assessing scapular positioning and movement, the Visual Analog Scale (VAS) for evaluating pain levels, the Seated Medicine Ball Throw Test (SMBT) for measuring upper body strength and throwing ability, the Functional Throwing Performance Index (FTPI) for assessing throwing accuracy and velocity, and spirometry alongside respiratory muscle strength assessments to analyze the impact of SD on breathing patterns and forced vital capacity.

2.1.2 Phase Two: Mobile Application Development The second phase of the study focuses on the development of a mobile application tailored for Frisbee players with scapular dyskinesia. This phase will follow an agile development process, characterized by iterative and incremental progress, allowing for continuous improvements and flexibility based on user feedback. The application will be developed using Flutter and Dart to ensure cross-platform compatibility, enabling it to run smoothly on both iOS and Android devices. The development process will incorporate multiple testing phases to ensure the app's effectiveness and user-friendliness. These phases include functional testing to verify compliance with specified requirements, usability testing to evaluate the user interface and experience, data validation testing to ensure data accuracy and integrity, regression testing to verify that updates do not negatively impact existing functionalities, and user acceptance testing to gather feedback from end-users to ensure the app meets their needs effectively.

2.1.3 Phase Three: Intervention and Evaluation In the third phase, a randomized controlled trial (RCT) will be conducted to evaluate the effectiveness of the gamified rehabilitation intervention delivered through the mobile application. The study will involve Frisbee players diagnosed with SD, divided into three groups: an experimental group receiving gamified scapular rehabilitation exercises through the mobile application, a control group engaging in standard rehabilitation exercises without the gamification component, and a healthy group serving as a baseline comparison. The experimental group will undergo an 8-week gamified rehabilitation program designed to enhance scapular muscle strength, positioning, and throwing performance, delivered via the mobile application with engaging elements to improve adherence and motivation. The primary outcome measures for this phase will include pre and post-intervention assessments of scapular muscle strength, positioning, and throwing performance, as well as adherence to the rehabilitation program evaluated using the Rehabilitation Adherence Questionnaire-Modified (RAQ-M).

2.2 Sample size For phase one, assuming the population size is 600, the confidence level is 95%, the margin of error set at 5% and the population with SD's proportion assumed as 50%, therefore, the calculated sample size is approximately 235. Phase two will employ a pilot study for user acceptance testing. A sample size of 15 participants will be employed for the user acceptance testing of the mobile application. This sample size is considered adequate to achieve the objectives of a pilot study while allowing for detailed feedback and iterative improvements. For phase three, the sample size calculation was done using G Power software, considering an attrition rate of 20%. With a desired power of 0.95, an effect size of 0.20, and a significance level of 0.05, a total sample size of 45 participants is required. This analysis accounts for three groups and eight repeated measurements per participant, with a moderate correlation among repeated measures. With this attrition rate factored in, the total sample size required is calculated to be 45 + 9 = 54 subjects. To distribute these subjects evenly among the groups, each group will consist of 18 subjects. This allocation ensures that each group has an adequate number of participants to detect meaningful differences in the outcomes being investigated while accounting for potential dropouts or withdrawals during the study.

2.3 Inclusion and Exclusion Criteria For this study, the inclusion criteria specify that participants must be competitive Frisbee players aged between 18 and 40 years. These individuals should engage in regular training sessions lasting 1.5 to 2 hours per session, with a minimum of one session per week. Additionally, participants are required to have a full range of motion in the Glenohumeral joint. Participants will be excluded if they are recreational Frisbee players, as they may not have the same level of athletic conditioning or skill as competitive players. Further exclusion criteria include any recent head or neck injuries within the past three months or any upper body surgery in the past year. Acute fractures in the shoulder girdle, spine, or thoracic cage, as well as any history of Chronic Obstructive Pulmonary Disease (COPD), uncontrolled asthma, pulmonary infectious diseases, or respiratory tract infectious diseases, also disqualify potential participants. Additionally, individuals with neuromuscular or neurological disorders such as Amyotrophic Lateral Sclerosis (ALS), Guillain-Barré Syndrome (GBS), or Multiple Sclerosis (MS) are excluded to ensure that the study results are not affected by these conditions, which could interfere with the study's focus on scapular dyskinesis among healthy, competitive athletes.

2.4 Baseline measurements This section outlines the outcome measures used to evaluate the baseline measurements for phases one and three of the study. The measures encompass a range of tests and evaluations to assess various physical attributes and functions related to scapular dyskinesis, pain perception, upper body power, throwing performance, pulmonary function, respiratory muscle strength, breathing patterns, and scapular muscle strength.

2.4.1 Lateral Scapular Slide Test (LSST) The Lateral Scapular Slide Test (LSST) assesses scapular position and dyskinesis. The test involves measuring the bilateral distance between the inferior angle of the scapula and the nearest vertebral spinous process in three distinct positions: with the arms relaxed at the side (0° humeral elevation), with the shoulder abducted to 40-45° with hands on hips, and with the shoulder abducted to 90° with arms in full internal rotation. A difference of more than 1.5 cm between the sides indicates scapular dyskinesis. While the LSST provides more objective measures compared to mere observation, it is not entirely reliable in assessing scapular asymmetry. Test-retest reliability ranges from 0.84 to 0.88, and intertester reliability varies between 0.77 and 0.85, according to.

2.4.2 Visual Analog Scale (VAS) The Visual Analog Scale (VAS) is used to measure the intensity of pain or other subjective experiences. It consists of a 10-centimeter horizontal or vertical line with anchor points representing extreme sensations, such as "No Pain" and "Worst Pain Imaginable." Participants mark a point on the line that reflects their experience. The distance from the "No Pain" end to the mark is measured, providing a quantitative score of the participant's perceived pain level.

2.4.3 Seated Medicine Ball Throw Test (SMBT) The Seated Medicine Ball Throw Test (SMBT) evaluates unilateral upper-extremity power by measuring the distance an individual can throw a 6-pound medicine ball from a seated position. The test assesses shoulder kinematics, movement patterns, and trunk engagement, with performance differences between dominant and non-dominant sides typically ranging from 5% to 10%. The test is considered a cost-effective and reliable method for assessing upper-body power.

2.4.4 Functional Throwing Performance Index (FTPI) The Functional Throwing Performance Index (FTPI) measures the accuracy of overhand throws. It is calculated by dividing the number of accurate throws by the total number of throws. Athletes stand 15 feet from a target and throw a ball at it as many times as possible within 30 seconds. Accuracy is determined by whether any part of the ball contacts the target.

2.4.5 Pulmonary Function Tests (PFTs) Evaluation of respiratory capacity will be done using a spirometer to measure Forced Expiratory Volume in one second (FEV1) and Forced Vital Capacity (FVC). Participants will be instructed to perform maximum inhalation and exhalation maneuvers, and the best result from three trials will be recorded. Normal FVC values range from 5.5 to 4.75 liters in males and 3.75 to 3.25 liters in females, while FEV1 values range from 4.5 to 3.5 liters in males and 3.25 to 2.5 liters in females. An FEV1/FVC ratio above 0.7 indicates normal pulmonary function.

2.4.6 Respiratory Muscle Strength Respiratory muscle strength is measured using a handheld respiratory pressure meter to assess Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP). Participants perform maneuvers involving maximal inhalation and exhalation with the help of a nose clip and a mouthpiece. Three attempts are recorded, and the average is used for analysis. Reference values suggest MIP should be less than -90 cmH2O for men and -70 cmH2O for women, while MEP should be greater than 140 cmH2O for men and 90 cmH2O for women.

2.4.7 Self-Evaluation of Breathing Questionnaire (SEBQ) The Self-Evaluation of Breathing Questionnaire (SEBQ) assesses breathing patterns and symptom severity. Participants respond to 25 items on a 3-point scale, indicating the frequency of symptoms, with higher scores suggesting more pronounced breathing dysfunction. Scores above 25 indicate significant diaphragmatic breathing issues.

2.4.8 Measurement of Throwing Velocity Throwing velocity is calculated by measuring the time it takes for a Frisbee to travel a fixed distance (60.5 feet) and using a stopwatch. The speed is calculated using the formula S=D/TS = D / TS=D/T, where SSS is speed, DDD is distance, and TTT is time. This speed is then converted to miles per hour (mph) for analysis.

2.4.9 Assessment of Scapular Muscle Strength Scapular muscle strength is assessed in two positions: seated and supine. Participants provide maximal strength against a handheld dynamometer, with manual resistance applied by the examiner. The test position is set between maximal scapular protraction and retraction, with participants asked to exert maximal strength like punching against the dynamometer.

2.5 Application development The development process involves collaboration among software developers, game designers, physiotherapists, and users to create a gamification framework that incorporates scapular stabilization exercises tailored to the needs of users. The agile development methodology is employed to ensure adaptability and collaboration, allowing the integration of features such as points, levels, challenges, feedback systems, and social features. The implementation utilizes the Flutter framework and Dart programming language within the Visual Studio IDE to ensure cross-platform compatibility, providing a consistent user experience on iOS and Android devices. Rigorous testing procedures, including functional, usability, data validation, regression, and user acceptance testing, are conducted to ensure the application's effectiveness, ease of use, and data integrity. These steps culminate in the creation of a user-friendly mobile application designed to make scapular rehabilitation engaging and effective for frisbee players with scapular dyskinesis.

2.6 Intervention and Follow Up The study will be conducted during pregame sessions, focusing on frisbee players diagnosed with SD identified in phase one. These players will be randomly divided into three groups using block randomization: an experimental group, Control Group A (both containing players with SD), and a healthy Control Group B consisting of players without SD. Each group will consist of 18 participants, with informed consent obtained prior to the study.

Baseline outcome measures, such as Visual Analog Scale (VAS) scores, Seated Medicine Ball Throw Test (SMBT), scapular muscle strength, Functional Throwing Performance Index (FTPI), throwing accuracy, SEBQ, and pulmonary function tests, will be assessed. The experimental group will use a mobile application featuring gamified scapular stabilization and postural correction exercises, while Control Group A will only perform postural correction exercises, and Control Group B will continue regular training without interventions. The study adopts a single-blinded design, where assessors are unaware of group allocations during assessments. Both the experimental group and Control Group A will receive an 8-week intervention, with post-intervention outcome measures reassessed for data analysis, including adherence using the Modified Rehabilitation Adherence Questionnaire (RAQ-M) which will be done after 6 months of intervention. The RAQ-M evaluates adherence behaviors, exercise consistency, barriers, motivation, and satisfaction with the rehabilitation program, providing insights to optimize interventions for musculoskeletal conditions. Additionally, participants will perform specific postural correction exercises such as Chin Tucks, Upper Back Stretch, and Cat-Camel Stretch to improve posture and alignment, while adherence will be tracked through the RAQ-M to assess motivation, challenges, and perceived benefits, ensuring comprehensive evaluation of the intervention's effectiveness.

Being tested
game based mobile application scapular stabilisation exercises, Postural correction exercises
Keywords
Overhead Athletes, Mobile Game, Adherence to Therapy, Digital Health Solutions, Tele-Rehabilitation, Scapular Stabilization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • game based mobile application scapular stabilisation exercisesOther

    novel game base exercise that mimics scapular stabilisation exercises.

  • Postural correction exercisesOther

    upper thorax postural correction exercises

Study groups in NCT07504653
Study groupRoleWhat they receive
Gaming GroupExperimentalThe experimental group will use a mobile application featuring gamified scapular stabilization and postural correction exercises
Receives: Other: game based mobile application scapular stabilisation exercises; Other: Postural correction exercises
Postural Correction groupActive comparatorControl Group A will only perform postural correction exercises
Receives: Other: Postural correction exercises
Regular training groupNo interventionControl Group B will continue regular training without interventions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Seated Medicine Ball Throw Test (SMBT)

    The Seated Medicine Ball Throw Test (SMBT) evaluates unilateral upper-extremity power by measuring the distance an individual can throw a 6-pound medicine ball from a seated position. The test assesses shoulder kinematics, movement patterns, and trunk engagement, with performance differences between dominant and non-dominant sides typically ranging from 5% to 10% (3). The test is considered a cost-effective and reliable method for assessing upper-body power.

    Measured: From enrollment to the end of treatment at 8 weeks

  2. Lateral Scapular Slide Test (LSST)

    The Lateral Scapular Slide Test (LSST) assesses scapular position and dyskinesis. The test involves measuring the bilateral distance between the inferior angle of the scapula and the nearest vertebral spinous process in three distinct positions: with the arms relaxed at the side (0° humeral elevation), with the shoulder abducted to 40-45° with hands on hips, and with the shoulder abducted to 90° with arms in full internal rotation. A difference of more than 1.5 cm between the sides indicates scapular dyskinesis (1). While the LSST provides more objective measures compared to mere observation, it is not entirely reliable in assessing scapular asymmetry. Test-retest reliability ranges from 0.84 to 0.88, and intertester reliability varies between 0.77 and 0.85.,

    Measured: From enrollment to the end of treatment at 8 weeks

  3. Functional Throwing Performance Index (FTPI)

    The Functional Throwing Performance Index (FTPI) measures the accuracy of overhand throws. It is calculated by dividing the number of accurate throws by the total number of throws. Athletes stand 15 feet from a target and throw a ball at it as many times as possible within 30 seconds. Accuracy is determined by whether any part of the ball contacts the target

    Measured: From enrollment to the end of treatment at 8 weeks

  4. Measurement of Throwing Velocity

    Throwing velocity is calculated by measuring the time it takes for a Frisbee to travel a fixed distance (60.5 feet) and using a stopwatch. The speed is calculated using the formula S=D/TS = D / TS=D/T, where SSS is speed, DDD is distance, and TTT is time. This speed is then converted to miles per hour (mph) for analysis

    Measured: From enrollment to the end of treatment at 8 weeks

Secondary outcomes (2)
  1. Pulmonary Function Tests (PFTs)

    Evaluation of respiratory capacity will be done using a spirometer to measure Forced Expiratory Volume in one second (FEV1) and Forced Vital Capacity (FVC). Participants will be instructed to perform maximum inhalation and exhalation maneuvers, and the best result from three trials will be recorded. Normal FVC values range from 5.5 to 4.75 liters in males and 3.75 to 3.25 liters in females, while FEV1 values range from 4.5 to 3.5 liters in males and 3.25 to 2.5 liters in females. An FEV1/FVC ratio above 0.7 indicates normal pulmonary function

    Measured: From enrollment to the end of treatment at 8 weeks

  2. Respiratory Muscle Strength

    Respiratory muscle strength is measured using a handheld respiratory pressure meter to assess Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP). Participants perform maneuvers involving maximal inhalation and exhalation with the help of a nose clip and a mouthpiece. Three attempts are recorded, and the average is used for analysis. Reference values suggest MIP should be less than -90 cmH2O for men and -70 cmH2O for women, while MEP should be greater than 140 cmH2O for men and 90 cmH2O for women

    Measured: From enrollment to the end of treatment at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2026
  2. Study startApr 2026 (estimated)
  3. Primary completionAug 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
For this study, the inclusion criteria specify that participants must be competitive Frisbee players aged between 18 and 40 years. These individuals should engage in regular training sessions lasting 1.5 to 2 hours per session, with a minimum of one session per week. Additionally, participants are required to have a full range of motion in the Glenohumeral joint, as highlighted by (27). Participants will be excluded if they are recreational Frisbee players, as they may not have the same level of athletic conditioning or skill as competitive players. Further exclusion criteria include any recent head or neck injuries within the past three months or any upper body surgery in the past year. Acute fractures in the shoulder girdle, spine, or thoracic cage, as well as any history of Chronic Obstructive Pulmonary Disease (COPD), uncontrolled asthma, pulmonary infectious diseases, or respiratory tract infectious diseases, also disqualify potential participants.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07504653
Sponsor's protocol ID
INTI/CPS/2025/001
Acronym
Experimental
Status last verified
Apr 2026
First submitted
26 Mar 2026
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all IPD that underlie results in a publication

Publications

  • Longo UG, Risi Ambrogioni L, Berton A, Candela V, Massaroni C, Carnevale A, Stelitano G, Schena E, Nazarian A, DeAngelis J, Denaro V. Scapular Dyskinesis: From Basic Science to Ultimate Treatment. Int J Environ Res Public Health. 2020 Apr 24;17(8):2974. doi: 10.3390/ijerph17082974.

    PubMed 32344746
  • Hulsman AM, Kaldewaij R, Hashemi MM, Zhang W, Koch SBJ, Figner B, Roelofs K, Klumpers F. Individual differences in costly fearful avoidance and the relation to psychophysiology. Behav Res Ther. 2021 Feb;137:103788. doi: 10.1016/j.brat.2020.103788. Epub 2020 Dec 21.

    PubMed 33422745
  • Hogan C, Corbett JA, Ashton S, Perraton L, Frame R, Dakic J. Scapular Dyskinesis Is Not an Isolated Risk Factor for Shoulder Injury in Athletes: A Systematic Review and Meta-analysis. Am J Sports Med. 2021 Aug;49(10):2843-2853. doi: 10.1177/0363546520968508. Epub 2020 Nov 19.

    PubMed 33211975

Questions about this trial

What is this clinical trial studying?

A study testing game based mobile application scapular stabilisation exercises and Postural correction exercises in people with Scapular Dyskinesis, run by INTI International University at 1 site in Malaysia.

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 4 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: looking for participants now, as of the sponsor's last update on 7 Apr 2026. 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 Malaysia. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact NITHIYAH MARUTHEY, Master of Physiotherapy (+60162015371, nithiyah.maruthey@newinti.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seated Medicine Ball Throw Test (SMBT) (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 4 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 NCT07504653, which also lists 3 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 7 Apr 2026.

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