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IRCT20250921067305N1 IRCT 2025-11-12 The University of Isfahan Individualized staged corrective exercise in adults with an upper crossed syndrome postural phenotype ISCEP The effect of adding an individualized staged corrective-exercise program to a foundational active intervention on the postural profile of adults meeting prespecified postural criteria for upper crossed syndrome: a randomized controlled trial 2026-11-22 anticipated 36 Pending https://irct.ir/trial/86313 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After completion of baseline assessment, an independent statistician will generate the allocation sequence using randomly permuted blocks of four and six, with a 1:1 allocation ratio and stratification by sex. Block sizes and the allocation sequence will remain concealed from personnel involved in recruitment and assessment. Allocation will be concealed using sequentially numbered, opaque, tamper-evident, sealed envelopes. The next envelope will be opened only after eligibility has been confirmed, baseline assessment completed, and the participant irreversibly enrolled, by a person who has no access to the allocation sequence, Blinding description: Because of the nature of the intervention, participants and the intervention provider cannot be blinded. Outcome assessors, EMG and EEG processors, and the statistician will remain blinded to group allocation until completion of the primary analysis. Images, Formetric outputs, and signal files will be coded without group or time-point information and presented in random order. The code key will be held by an independent person, and any inadvertent unblinding will be documented. N/A Upper Crossed Syndrome. Intervention 1: The intervention group will receive three sessions per week for 12 weeks, totaling 36 sessions. Each session will last approximately 60–80 minutes and comprise 10 minutes of stationary cycling, one to two minutes of transition and preparation, 40–55 minutes of main exercise, and 5–10 minutes of cool-down, stretching, or indication-based manual techniques. In addition to the components shared by both groups, the individualized staged program comprises overlapping stages addressing breathing and trunk control, restoration of mobility, retraining of muscle activation and coordination, basic movements, fundamental and functional movement patterns, and progression toward load tolerance and health-related physical fitness. Exercise selection, regression, and progression will follow prespecified criteria and individual response. Sessions will be delivered individually or to no more than three participants per provider. Intervention 2: The active-comparator group will attend three sessions per week for 12 weeks, totaling 36 sessions. Each session will last approximately 20–30 minutes and comprise 10 minutes of stationary cycling, indication-based stretching of target muscles, prespecified mobilizations, and education on healthy movement habits. The type, sequence, and dose of the shared components will match the corresponding components in the intervention group. This group will not receive exercises based on the staged model, retraining of muscle activation and coordination, training of basic or complex movement patterns, individualized progression of load and task, or the specific transition toward health-related physical fitness. Participants will continue their usual activities and will not begin a new structured exercise program outside the study. Yes - There is a plan to make this available What will be shared: The approved protocol, amendments, statistical analysis plan, data dictionary, analytic code, and the deidentified individual-level minimal dataset will be deposited in a stable public repository when the trial results are published. Coded assessment photographs and videos and raw biosignals that may carry a residual risk of re-identification will not be made publicly available and may be requested only through controlled-access procedures. When: Publicly shareable files will be deposited in a stable repository when the primary trial results are published and will remain available indefinitely or according to repository policy. Requests for controlled access to sensitive data may be considered after publication of the trial results. To whom: The deidentified minimal dataset, data dictionary, and analytic code will be available to researchers through a public repository. Access to sensitive data will require a specific and justified scientific purpose, approval by the relevant institutional body or ethics committee, and execution of a data-use agreement. Access decisions will not be controlled by a single author. Conditions: Performing statistical analyses within the scope of published articles related to the present research is permissible. However, the misuse of data to extract new findings is strictly prohibited. Where to obtain: The public repository link will be added to the trial record and results article when available. Requests for controlled access to sensitive data should be submitted to the institutional email address m.khorami@spr.ui.ac.ir and should specify the research purpose, requested data, analysis plan, institutional or ethics approval, and data-protection plan. Requests will be reviewed by the relevant institutional body and research team; approved access will be provided under a data-use agreement. How to obtain: The applicant must provide a compelling and specific justification for requesting the data. Upon receipt of the request, they will be notified that their application is under review. Following approval by the research team, the data will be made available to the applicant within one month from the start of the request review. Comments:
public Mohamad Khorami Moghadam
No. 6, Laleh 2, Shekh Mofid Ave, Arak
Arak Iran (Islamic Republic of) 3816137667 +98 86 3222 9722 m.khorami@hotmailm.com The university of Isfahan scientific Mohamad Khorami Moghadam
No 6, laleh 2, Sheykh Mofid Ave, Arak
Arak Iran (Islamic Republic of) 3816137667 +98 86 3222 9722 m.khorami@spr.ui.ac.ir The University of Isfahan Iran (Islamic Republic of) Female or male, aged 18–40 years, and residing in Arak Concurrent presence of a forward-head angle of at least 44 degrees, a forward-shoulder angle of at least 49 degrees, and thoracic kyphosis of at least 42 degrees Body mass index of 18.5–24.9 kg/m² Ability to complete the assessments and exercise program safely Willingness to maintain the usual pattern of physical activity and refrain from beginning a new structured exercise program outside the study Ability to attend intervention sessions and study assessments Provision of written informed consent before formal assessment 18 years 40 years Both History of surgery or fracture affecting the spine, shoulder girdle, or pelvis A diagnosed neurological, psychiatric, or musculoskeletal condition that could compromise safety or confound the outcomes Use of medication affecting the central nervous system Acute pain or uncontrolled cardiopulmonary disease Pregnancy An angle of trunk rotation greater than five degrees during the forward-bending test A lower-limb or pelvic disorder that precludes valid balance testing Regular participation in corrective exercise, resistance training, or manual therapy during the preceding three months R29.3 Abnormal posture Lifestyle Lifestyle The intervention group will receive three sessions per week for 12 weeks, totaling 36 sessions. Each session will last approximately 60–80 minutes and comprise 10 minutes of stationary cycling, one to two minutes of transition and preparation, 40–55 minutes of main exercise, and 5–10 minutes of cool-down, stretching, or indication-based manual techniques. In addition to the components shared by both groups, the individualized staged program comprises overlapping stages addressing breathing and trunk control, restoration of mobility, retraining of muscle activation and coordination, basic movements, fundamental and functional movement patterns, and progression toward load tolerance and health-related physical fitness. Exercise selection, regression, and progression will follow prespecified criteria and individual response. Sessions will be delivered individually or to no more than three participants per provider. The active-comparator group will attend three sessions per week for 12 weeks, totaling 36 sessions. Each session will last approximately 20–30 minutes and comprise 10 minutes of stationary cycling, indication-based stretching of target muscles, prespecified mobilizations, and education on healthy movement habits. The type, sequence, and dose of the shared components will match the corresponding components in the intervention group. This group will not receive exercises based on the staged model, retraining of muscle activation and coordination, training of basic or complex movement patterns, individualized progression of load and task, or the specific transition toward health-related physical fitness. Participants will continue their usual activities and will not begin a new structured exercise program outside the study. Forward-head angle; the first component of the multivariate primary postural outcome. A lower angle is favorable. Timepoint: Baseline, week 12, and four-week follow-up; the primary comparison is at week 12. Method of measurement: Mean of three lateral photographs; C7–tragus angle relative to the vertical, calculated using AutoCAD 2025. Forward-shoulder angle; the second component of the multivariate primary postural outcome. A lower angle is favorable. Timepoint: Baseline, week 12, and four-week follow-up; the primary comparison is at week 12. Method of measurement: Mean of three lateral photographs; C7–acromion angle relative to the vertical, calculated using AutoCAD 2025. Thoracic-kyphosis angle; the third component of the multivariate primary postural outcome. A lower angle is favorable. Timepoint: Baseline, week 12, and four-week follow-up; the primary comparison is at week 12. Method of measurement: Mean of six DIERS formetric 4D scans; ICT–ITL angle calculated using DICAM 3. Normalized RMS amplitude of the dominant-side upper, middle, and lower trapezius and serratus anterior. Timepoint: Baseline and week 12. Method of measurement: Eight-channel wireless Noraxon surface EMG; MVIC normalization and mean of three valid seven-second trials. Description: UT/MT, UT/LT, and UT/SA ratios based on normalized whole-task EMG amplitude. Timepoint: Baseline and week 12. Method of measurement: Ratios calculated from the mean normalized RMS of three valid trials. Active flexion range of motion of the dominant shoulder. Timepoint: Baseline, week 12, and four-week follow-up. Method of measurement: Mean of three measurements using a 360-degree universal goniometer. Active external-rotation range of motion of the dominant shoulder. Timepoint: Baseline, week 12, and four-week follow-up. Method of measurement: Mean of three measurements using a 360-degree universal goniometer. Active cervical-flexion range of motion. Timepoint: Baseline, week 12, and four-week follow-up. Method of measurement: Mean of three measurements using a 360-degree universal goniometer. Mean center-of-pressure velocity during eyes-open and eyes-closed Romberg tests. Timepoint: Baseline, week 12, and four-week follow-up. Method of measurement: Mean of three valid 30-second trials measured using DIERS Pedoscan. Lower Quarter Y-Balance composite score of the dominant limb. Timepoint: Baseline, week 12, and four-week follow-up. Method of measurement: Maximum reach in three directions normalized to limb length; three valid trials. Change in central relative alpha power, averaged across C3, Cz, and C4, during quiet standing with eyes open; exploratory EEG outcome. Timepoint: Baseline and week 12. Method of measurement: Recorded using 24-channel EEG 3840 at 500 Hz; relative alpha power from 8 to <13 Hz calculated using EEGLAB 2026.0.0. The University of Isfahan Approved 2025-05-31 research Ethics Committees of University of Isfahan Isfahan University, Azadi Square, Isfahan Isfahan Isfehan Iran (Islamic Republic of)