Trial · NCT07897253
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Scar Pressure Pain Threshold Measured Using a Digital Pressure Algometer (Newtons) | Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8) | Scar pressure pain threshold will be assessed using a digital pressure algometer to quantify the force applied at the point when the participant first perceives pressure as painful. Measurements will be taken twice at each of five standardized points along the cesarean scar. Force will be recorded in Newtons (N). The mean pressure pain threshold across the two measurements at each site will be recorded, and then the total mean pressure threshold for all 5 sites together will be calculated for analysis. If appropriate, site-specific values and, the mean across the five measurement sites will be reported. This is a non-invasive assessment. Pressure pain threshold was selected as an objective measure of scar sensitivity because reducing scar-related sensitivity is an anticipated effect of the scar-focused rehabilitation intervention. |
| Primary | Cesarean Scar Mobility Measured Using a Modified Adherometer (mm²) | Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8) | Scar mobility will be assessed using a modified adherometer at five standardized points along the cesarean scar. Displacement will be measured in millimeters (mm) in three directions: upward, leftward, and rightward. Surface mobility (SM) will be calculated in square millimeters (mm²) using the prespecified method (SM=((left + right) x (up)/2) for combining measurements across directions. The mean SM will then be calculated by averaging the SM values obtained at the five standardized points, yielding one overall SM value per participant. If appropriate, site-specific values at each of the five measurement sites will be reported. Higher values indicate greater scar mobility. Scar mobility was selected as an objective measure of tissue restriction because improving scar and surrounding tissue mobility is a targeted effect of the scar-focused rehabilitation intervention. |
| Primary | SCAR-Q Questionnaire Scores for Scar Appearance, Symptoms, and Psychosocial Impact (0-100) | Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8) | Scar-related patient-reported outcomes will be assessed using the SCAR-Q questionnaire. Scores will be calculated separately for the applicable domains of scar appearance, symptoms, and psychosocial impact according to the instrument's scoring guidelines. Raw responses will be converted to Rasch-transformed scores ranging from 0 to 100, with higher scores indicating better outcomes. Changes in domain scores from baseline will be evaluated over the study period. The SCAR-Q was selected as a validated patient-reported outcome measure to capture the participant's perception of scar appearance, symptoms, and psychosocial impact, providing a complementary assessment of clinically relevant scar-related outcomes not captured by objective measures of scar mobility and sensitivity. |
| Primary | Pelvic Girdle Pain-Related Disability Score Measured Using the Pelvic Girdle Pain Questionnaire (0-100) | Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8) | Pelvic girdle pain-related symptoms and activity limitations will be assessed using the Pelvic Girdle Pain Questionnaire. The questionnaire score will be calculated and converted to a percentage (sum of scores/75\*100) according to the instrument's validated scoring instructions, with scores ranging from 0 to 100. Higher scores indicate greater symptom burden and disability, while lower scores indicate fewer symptoms and less disability. Changes in scores from baseline will be evaluated over the study period. The PGQ was selected as a validated measure of pelvic girdle pain-related symptoms and functional limitations because reducing pain-related disability and improving physical function are anticipated effects of the rehabilitation intervention. |
| Secondary | Number of Sit-to-Stand Repetitions Completed in 30 Seconds | Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8) | Lower-body functional performance will be assessed using the 30-Second Sit-to-Stand Test. The number of correctly completed sit-to-stand repetitions within 30 seconds will be recorded. A higher number of repetitions indicates greater functional capacity. Changes in the number of repetitions from baseline will be evaluated over the study period. |
| Secondary | Patient-Specific Functional Scale Mean Activity Score (0-10) | Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8) | Activity-related functional limitations will be assessed using the Patient-Specific Functional Scale. Each participant will identify three activities that are important to them and that have become difficult following cesarean birth. Each activity will be rated on a scale from 0 (unable to perform the activity) to 10 (able to perform the activity at the pre-problem level). The mean score will be calculated by summing the three activity ratings and dividing by the number of activities rated. Higher scores indicate better self-reported functional ability. Changes in the mean score from baseline will be evaluated over the study period. |
| Secondary | Dynamic Tissue Displacement Measured Using Diagnostic Ultrasound | Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8) | Dynamic ultrasound videos will be obtained at five standardized points along the scar, with the transducer positioned vertically, while participants perform a deep inspiration. Tissue displacement relative to adjacent tissue layers will be measured to assess tissue sliding. A displacement of \<1 cm or more will be classified as a negative sliding sign, indicating restricted tissue mobility potentially consistent with adhesions; a displacement of 1 cm or greater will be classified as a positive sliding sign. Continuous measurements of tissue displacement and the proportion of sites classified as having a positive sliding sign will be reported. Changes in ultrasound-derived measurements from baseline will be evaluated over the study period. |
| Secondary | Cesarean Scar Thickness Measured Using Diagnostic Ultrasound | Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8) | Diagnostic ultrasound will be used to assess cesarean scar thickness. Static ultrasound images will be obtained at three standardized points along the length of the cesarean scar, with the transducer positioned horizontally. Scar thickness will be measured in millimeters (mm) using Digital Imaging and Communications in Medicine (DICOM) imaging software. The mean scar thickness across the three standardized measurement points will be calculated, with higher values indicating greater scar thickness. Changes in ultrasound-derived measurements from baseline will be evaluated over the study period. |
| Secondary | Tissue Echogenicity Measured Using Diagnostic Ultrasound | Comparing baseline (enrollment), mid point (week 4) and end point of study (week 8) | Diagnostic ultrasound will be used to assess cesarean scar tissue echogenicity. Static ultrasound images will be obtained at three standardized points along the length of the cesarean scar, with the transducer positioned horizontally. Echogenicity will be quantified using grayscale analysis within a standardized region of interest (ROI) encompassing the scar tissue. Mean pixel intensity will be calculated on a grayscale ranging from 0 (black) to 255 (white), with higher values indicating greater tissue echogenicity. The echogenity across the three standarized measurement points will be reported for each participant. If appropriate, the mean echogenicity across the three standardized measurement points will be calculated to provide a single value for each participant. |
| Secondary | Participant-Reported Feasibility and Acceptability of the Hybrid Postpartum Rehabilitation Program | Questionnaire completed at end point testing (week 8) | At the end of the intervention, participants will complete a study-specific feasibility questionnaire containing Likert-scale items and open-ended questions. The questionnaire will assess participant perceptions of the hybrid rehabilitation model, including the combination of online and in-person sessions, the number and target areas of the prescribed exercises, and the acceptability of self-administered scar release and massage. Responses to Likert-scale items will be summarized descriptively, and open-ended responses will be analyzed thematically. No single composite score will be calculated unless a scoring method has been prespecified. |
| Secondary | Study Retention rate | Throughout the study recruitment period, from recruitment initiation until the target sample size is reached. On average 1 year. | Retention feasibility will be assessed by documenting the number of participants who complete the study relative to the number enrolled. The retention rate will be calculated as the number of participants who complete the study divided by the number of participants enrolled, expressed as a percentage: Retention rate (%) = (Number of participants who complete the study / Number of participants enrolled) × 100 |
| Secondary | Study Feasibility of Recruitment | Throughout the study recruitment period, from recruitment initiation until the target sample size is reached. On average 1 year. | Recruitment feasibility will be assessed by documenting the number of individuals who complete the study eligibility screening form, the number and proportion who are determined to be eligible or ineligible, and the number of eligible individuals who enroll in the study. The recruitment rate will be calculated as the number of participants enrolled divided by the number of individuals determined to be eligible, expressed as a percentage: Recruitment rate (%) = (Number enrolled / Number eligible) × 100 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07897253/registered