Trial · NCT07892196
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Chronic Pain Intensity From Baseline to 6 Months | Baseline (Month 0) and Month 6 | Assessed using the Visual Analog Scale (VAS) component of the Adolescent Pediatric Pain Tool (APPT). Pain intensity is marked along a 100 mm horizontal line, where 0 mm indicates 'no pain' and 100 mm indicates 'worst possible pain'. Pain levels are categorized as: 0-4 mm (no pain), 5-44 mm (mild pain), 45-74 mm (moderate pain), and 75-100 mm (severe pain). Higher scores reflect greater pain severity. |
| Secondary | Change in Pain Interference on Daily Activities From Baseline to 6 Months | Baseline (Month 0) and Month 6 | ssessed using the 7-item Pain Interference Scale of the Brief Pain Inventory (BPI). It evaluates how much pain interferes with 7 daily life domains (general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life) over the past 24 hours. Each item is rated on an 11-point numeric scale from 0 (does not interfere) to 10 (completely interferes). The total score ranges from 0 to 70, with higher scores indicating greater pain interference in daily functioning. |
| Secondary | Change in the Number of Anatomical Pain Sites From Baseline to 6 Months | Baseline (Month 0) and Month 6 | Assessed using the pediatric body diagram of the Adolescent Pediatric Pain Tool (APPT). Participants mark all anatomical regions where they experience pain. The total number of painful body areas is quantified, with higher numbers indicating more widespread pain. |
| Secondary | Change in Pain Quality Descriptors From Baseline to 6 Months | Baseline (Month 0) and Month 6 | Assessed using the word descriptor component of the Adolescent Pediatric Pain Tool (APPT), which evaluates 4 dimensions of pain quality: sensory, affective, evaluative, and temporal across a total of 15 words. Scores are calculated as percentages of selected words relative to the total number of words within each dimension (0% to 100%). Higher percentage scores indicate greater endorsement of that specific pain dimension. |
| Secondary | Change in Pediatric Pain Coping Strategies From Baseline to 6 Months | Baseline (Month 0) and Month 6 | Assessed using the Pediatric Pain Coping Inventory (PPCI, adolescent and parent-proxy versions). It measures coping strategies across 5 subscales: cognitive self-instruction, problem solving, distraction, seeking social support, and catastrophizing/helplessness. Items are scored on a 3-point Likert scale (0 = never, 1 = sometimes, 2 = often). Higher scores in each subscale indicate more frequent utilization of that specific coping strategy. |
| Secondary | Change in Ambulatory Motor Performance From Baseline to 6 Months | Baseline (Month 0) and Month 6 | Assessed using the North Star Ambulatory Assessment (NSAA) in ambulatory participants. It evaluates 17 motor activities (such as standing, walking, rising from a chair, jumping, and running). Each item is scored on a 3-point scale: 0 (unable to achieve independently), 1 (achieves with modifications), and 2 (normal performance). Total raw scores range from 0 to 34, with higher scores reflecting better motor and functional capability. |
| Secondary | Change in Functional Exercise Capacity From Baseline to 6 Months | Baseline (Month 0) and Month 6 | Evaluated using the modified 6-Minute Walk Test (6MWT) according to standard DMD protocols in ambulatory participants capable of walking at least 75 meters. Total distance walked in 6 minutes is recorded in meters. A greater distance indicates better functional exercise tolerance. |
| Secondary | Change in Lower and Upper Extremity Functional Disability Stages From Baseline to 6 Months | Baseline (Month 0) and Month 6 | Lower extremity function is evaluated using the Vignos Scale (grades 1 to 10, ranging from 1 = walks and climbs stairs without assistance to 10 = bedridden). Upper extremity function is evaluated using the Brooke Scale (grades 1 to 6, ranging from 1 = arms abducted in a full circle to touch above head to 6 = no useful hand function). For both scales, higher numerical scores indicate more severe functional disability. |
| Secondary | Change in Muscle Strength From Baseline to 6 Months | Baseline (Month 0) and Month 6 | Handgrip strength is measured bilaterally using an electronic hand dynamometer in kilograms (kg), recording the average and maximum of 3 trials. Proximal and distal muscle strength is assessed bilaterally using Manual Muscle Testing (MMT) with the Medical Research Council (MRC) scale (0 = no movement to 5 = normal strength). Total muscle strength is calculated as a composite percentage score (%MRC) using the standard formula: (Total score × 100) / (Number of tested muscles × 5). Higher values indicate greater muscle strength. |
| Secondary | Change in Timed Stair Climbing and Descending Performance From Baseline to 6 Months | Baseline (Month 0) and Month 6 | Timed performance to ascend and descend a standard 4-step flight of stairs is measured in seconds using a digital stopwatch. Shorter completion times indicate superior functional mobility and lower extremity motor velocity. |
| Secondary | Change in Joint Range of Motion and Presence of Contractures From Baseline to 6 Months | Baseline (Month 0) and Month 6 | Passive joint range of motion (ROM) is measured in degrees using a standard goniometer across cervical, shoulder, elbow, wrist, metacarpophalangeal, hip, knee, and ankle joints. Contracture is defined as passive loss of full normal joint ROM compared to age-matched reference standards. Lower degrees of passive ROM indicate greater joint contracture severity. |
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
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GET https://conductscience.org/api/trials/v1/NCT07892196/registered