[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659945":3},{"organization":4,"outcomesModule":7,"designInfo":77,"detailedDescription":76,"studyPopulation":76,"armGroups":83,"interventions":100,"overallOfficials":114,"centralContacts":119,"locations":124,"responsibleParty":133,"collaborators":76,"id":135,"slug":136,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":76,"eligibilityCriteria":141,"healthyVolunteers":137,"sex":142,"minAge":143,"maxAge":144,"enrollmentInfo":145,"targetDuration":76,"studyType":148,"phases":149,"briefSummary":151,"conditions":152,"keywords":156,"overallStatus":161,"whyStopped":76,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},{"fullName":5,"class":6},"National Taiwan University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":76},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Longitudinal Muscle Displacement of the Biceps Femoris Long Head (Arm 1)","Longitudinal muscle displacement in millimeters of the middle biceps femoris long head (BFlh) tracked using ultrasound speckle tracking during a 20°\u002Fs maximal pain-free isokinetic eccentric knee flexion task.","Baseline and Week 8 post-intervention",{"measure":14,"description":15,"timeFrame":16},"Posterior Tibial Tendon Dynamic Torsion, Tendon Displacement, and Shear Wave Velocity (Arm 2)","PTT dynamic torsion and displacement quantified using cross-sectional ultrasound speckle tracking during maximal isometric foot adduction, and tendon mechanical properties evaluated as mean shear wave velocity using shear wave elastography at proximal and distal tibialis posterior tendon.","Baseline, Week 6 (post-intervention), and Week 12 (follow-up)",{"measure":18,"description":19,"timeFrame":12},"Regional Strain of the Reconstructed mUCLAB Graft (Arm 3)","Regional engineering strain along the longitudinal axis of the reconstructed medial ulnar collateral ligament anterior bundle (mUCLAB) across proximal, middle, and distal regions, quantified using ultrasound speckle tracking under a standardized 5 N·m dynamic valgus torque.",[21,24,27,30,33,36,39,42,45,49,52,55,58,61,64,67,70,73],{"measure":22,"description":23,"timeFrame":12},"Eccentric Knee Flexor Peak Torque (Arm 1)","Maximal eccentric knee flexor peak torque (N·m) evaluated at 20°\u002Fs isokinetic velocity using an isokinetic dynamometer (Biodex Medical Systems, NY, USA) across a range of 90° to 0° knee flexion.",{"measure":25,"description":26,"timeFrame":12},"Functional Assessment Scale for Acute Hamstring Injuries (FASH) Score (Arm 1)","Self-reported hamstring injury symptoms and physical function assessed using the FASH questionnaire. The score ranges from 0 to 100, where higher scores indicate superior hamstring function and less severity of symptoms.",{"measure":28,"description":29,"timeFrame":12},"Long Head of Biceps Femoris Muscle Shear Wave Velocity (Arm 1)","Resting muscle stiffness quantified as shear wave velocity (m\u002Fs) at the suspected BFlh injury site and adjacent regions (1 cm proximal and distal) using shear wave elastography with a curved transducer.",{"measure":31,"description":32,"timeFrame":12},"Intramuscular Power Doppler Vascularity Grade (Arm 1)","Vascularity around the suspected BFlh injury site evaluated using power Doppler ultrasonography on a 4-point ordinal scale: Grade 0 (no flow or 1 color pixel), Grade 1 (2-3 color pixels or 1 vessel), Grade 2 (2-3 vessels), and Grade 3 (\\>3 vessels).",{"measure":34,"description":35,"timeFrame":12},"Intramuscular Scar Gap Size During Isometric Contraction (Arm 1)","Measurement of the presence and gap size (mm) around the intramuscular scar tissue visualized in the longitudinal view under dynamic B-mode ultrasound during maximal voluntary isometric knee flexion at 30°.",{"measure":37,"description":38,"timeFrame":12},"Hamstring Flexibility (Arm 1)","Hamstring flexibility evaluated via the active knee extension test in a supine 90-90 hip-knee position, recorded as the final achieved knee extension angle (in degrees, °) measured with a goniometer.",{"measure":40,"description":41,"timeFrame":16},"Revised Foot Function Index (FFI-R) (Arm 2)","Patient-reported foot symptoms, pain, disability, and activity limitation evaluated via the Revised Foot Function Index (FFI-R), scored from 0 to 100 with higher scores reflecting greater impairment.",{"measure":43,"description":44,"timeFrame":16},"Musculoskeletal Health Questionnaire (MSK-HQ) Score (Arm 2)","Overall musculoskeletal health status and quality of life assessed via the MSK-HQ. The total score ranges from 0 to 56, with higher scores representing better musculoskeletal health.",{"measure":46,"description":47,"timeFrame":48},"Visual Analog Scale (Arm 2)","Patient self-reported foot pain intensity measured on a 100-mm Visual Analog Scale (VAS), where 0 mm indicates no pain and 100 mm indicates worst imaginable pain.","Baseline, each treatment session before\u002Fafter, Week 6, and Week 12 (follow-up)",{"measure":50,"description":51,"timeFrame":16},"Single-Leg Heel-Rise Test (Arm 2)","Functional performance of the posterior tibial muscle evaluated via the single-leg heel-rise test, documenting heel elevation height (cm) and the presence of heel inversion.",{"measure":53,"description":54,"timeFrame":16},"Maximal Voluntary Isometric Foot Inversion Torque (Arm 2)","Maximal voluntary isometric foot inversion peak torque (N·m) measured using an isokinetic dynamometer (Biodex Medical Systems, NY, USA) with simultaneous electromyography monitoring to ensure isolation of the posterior tibialis.",{"measure":56,"description":57,"timeFrame":16},"Five-Minute Walk Test (Arm 2)","Functional walking capacity evaluated as the total distance walked (in meters) within 5 minutes.",{"measure":59,"description":60,"timeFrame":16},"Y-Balance Test (Arm 2)","Dynamic standing balance evaluated via the Y-balance test with the stance leg, recording foot excursion (in cm) during movement of the reach leg.",{"measure":62,"description":63,"timeFrame":12},"Countermovement Push-Up (CMPU) Maximal Vertical Force (Arm 3)","Upper-extremity explosive strength and power assessed as maximal vertical ground reaction force (in Newtons) recorded on a portable force plate during the CMPU test.",{"measure":65,"description":66,"timeFrame":12},"Disabilities of the Arm, Shoulder, and Hand (DASH) Score (Arm 3)","Subjective upper-extremity functional recovery and disability assessed using the Taiwan version of the DASH questionnaire, scored from 0 to 100 (higher scores indicate greater disability and symptom severity).",{"measure":68,"description":69,"timeFrame":12},"Regional Young's Modulus of Reconstructed mUCLAB (Arm 3)","Tissue elasticity and stiffness (in kPa) of the reconstructed mUCLAB measured at the proximal, middle, and distal regions using shear wave elastography.",{"measure":71,"description":72,"timeFrame":12},"Shoulder and Elbow Maximal Voluntary Isometric Muscle Strength (Arm 3)","Maximal voluntary isometric contraction strength (in Newtons or kilograms) of the shoulder and elbow muscle groups measured using a hand-held dynamometer (microFET®2, Hoogan Health Industries, West Jordan, UT, USA).",{"measure":74,"description":75,"timeFrame":12},"Shoulder and Elbow Active Range of Motion (Arm 3)","Active range of motion (in degrees, °) of the shoulder (flexion, internal\u002Fexternal rotation) and elbow (flexion, extension, pronation, supination) measured using a standard universal goniometer.",null,{"allocation":78,"interventionModel":79,"interventionModelDescription":76,"primaryPurpose":80,"observationalModel":76,"timePerspective":76,"maskingInfo":81},"NON_RANDOMIZED","SINGLE_GROUP","TREATMENT",{"masking":82,"maskingDescription":76,"whoMasked":76},"NONE",[84,90,95],{"label":85,"type":86,"description":87,"interventionNames":88},"Athletes with BFlh Strain with Limited Return","EXPERIMENTAL","Athletes within 6 months of a unilateral biceps femoris long head (BFlh) muscle injury who have returned to the team but cannot fully participate in high-intensity training or competition. Participants complete an 8-week progressive Nordic hamstring exercise program (twice weekly, progressing from 3 sets of 6 to 3 sets of 12 repetitions) to evaluate changes in muscle displacement and eccentric knee flexor strength.",[89],"Behavioral: Nordic Hamstring Exercise Training",{"label":91,"type":86,"description":92,"interventionNames":93},"Adults with Symptomatic Adult Aquired Flatfoot Deformity","Adults aged 18-80 years diagnosed with symptomatic flexible flatfoot (FPI-6 score \\>= 6 or navicular drop \\> 9 mm). Participants undergo 6 weeks of conservative therapy consisting of daily custom foot orthoses, progressive posterior tibial tendon eccentric training (twice weekly), daily short-foot exercises, and calf stretching, followed by evaluation at baseline, week 6, and week 12 follow-up.",[94],"Behavioral: Custom Foot Orthoses and Exercise Therapy",{"label":96,"type":86,"description":97,"interventionNames":98},"Overhead Athletes with Post-mUCL Reconstruction","Overhead athletes aged 18-35 years who have undergone unilateral medial ulnar collateral ligament anterior bundle (mUCLAB) reconstruction and returned to training or competition. Participants complete an 8-week progressive isokinetic strength training program targeting the forearm flexor-pronator mass under blood flow restriction twice weekly.",[99],"Other: Forearm Blood Flow Restriction Training",[101,106,110],{"type":102,"name":103,"description":104,"armGroupLabels":105,"otherNames":76},"BEHAVIORAL","Nordic Hamstring Exercise Training","An 8-week progressive Nordic hamstring curl exercise protocol performed twice weekly. Following initial technique instruction, participants perform progressive eccentric hamstring curls starting from 3 sets of 6 repetitions in weeks 1-2 and progressing to 3 sets of 12 repetitions in weeks 7-8.",[85],{"type":102,"name":107,"description":108,"armGroupLabels":109,"otherNames":76},"Custom Foot Orthoses and Exercise Therapy","A 6-week conservative program consisting of: (1) Wearing custom-molded foot orthoses daily during ambulatory activities; (2) Progressive eccentric posterior tibial tendon strengthening on an isokinetic dynamometer (twice a week, 3 sets of 15 repetitions); (3) Progressive short-foot exercises (30-40 repetitions daily); and (4) Gastrocnemius and soleus stretching.",[91],{"type":6,"name":111,"description":112,"armGroupLabels":113,"otherNames":76},"Forearm Blood Flow Restriction Training","An 8-week progressive isokinetic strength training program targeting the forearm flexor-pronator muscles (pronator teres, flexor carpi ulnaris, brachialis) and handgrip, performed twice weekly. Exercises are performed under pneumatic blood flow restriction set at 70% limb occlusion pressure (LOP) of the brachial artery, at 40-60% of maximal voluntary isometric contraction (4 sets of 20 repetitions per muscle group).",[96],[115],{"name":116,"affiliation":117,"role":118},"Hsing-Kuo Wang, DPT, PhD","School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University","STUDY_CHAIR",[120],{"name":116,"role":121,"phone":122,"phoneExt":76,"email":123},"CONTACT","+886 02-33668154","hkwang@ntu.edu.tw",[125],{"facility":117,"status":76,"city":126,"state":127,"zip":128,"country":129,"countryCode":130,"cosmosGeoPoint":76,"geoPoint":76,"contacts":131},"Taipei City","Taipei","10055","Taiwan","TW",[132],{"name":116,"role":121,"phone":122,"phoneExt":76,"email":123},{"type":134,"investigatorFullName":76,"investigatorTitle":76,"investigatorAffiliation":76,"oldNameTitle":76,"oldOrganization":76},"SPONSOR","100659945","correlation-between-soft-tissue-displacement-and-functional-performance-in-orthopedic-patients-100659945",false,"NCT07870408","Correlation Between Soft Tissue Displacement and Functional Performance in Orthopedic Patients","Correlation Between Soft Tissue Displacement and Functional Performance in Orthopedic Patients: Muscle Injury, Tendon Dysfunction, and Ligament Reconstruction","Part 1\n\nInclusion Criteria:\n\n* Aged between 18 and 40 years\n* Participatd in regular physical exercise for at least 2.5 hours per week\n* Experimental group: Sustained a unilateral hamstring muscle injury diagnosed as a muscle strain within the past 6 months, have returned to the team, but currently remain unable to fully participate in training or competition at maximal intensity\n* Control group: Sustained a unilateral hamstring muscle injury within the past 6 months, have achieved full return to sport, and are fully able to participate in maximal-intensity training and competition\n* Palpation assessment confirms tenderness isolated to the unilateral biceps femoris long head\n\nExclusion Criteria:\n\n* Palpable distinct defect or gap within the injured biceps femoris long head resembling a severe (grade III) muscle tear\n* Known systemic diseases that may alter soft tissue composition and mechanical properties\n* Other musculoskeletal injuries of the lower extremity within the past 6 months (e.g., fractures)\n* History of surgery in the lower extremities\n* Any lower extremity orthopedic conditions (e.g., knee osteoarthritis, patellofemoral pain)\n\nPart 2\n\nInclusion Criteria:\n\n* Aged between 18 and 80 years\n* Diagnosed with functional or flexible flatfoot and recommended for conservative treatment by a physician\n* Six-Item Foot Posture Index (FPI-6) score \\>= 6, or a navicular drop test (NDT) \\> 9 mm.\n\nExclusion Criteria:\n\n* Recommended by a physician to undergo surgical treatment\n* Structural or rigid flatfoot\n* Posterior tibial tendon rupture or tendinopathy (including acute tenosynovitis or chronic tendinosis)\n* Presence of chronic ankle instability, or residual symptoms resulting from traumatic foot ligament tear\n* Other lower-extremity neuromusculoskeletal disorders, trauma with residual symptoms, or history of surgical intervention\n* Any physical condition that could interfere with the study procedures\n\nPart 3\n\nInclusion Criteria:\n\n* Overhead throwing athletes aged between 18 and 35 years\n* History of unilateral anterior bundle medial ulnar collateral ligament (mUCLAB) reconstruction\n* Have returned to sports training and competition following reconstruction surgery\n\nExclusion Criteria:\n\n* Known systemic diseases that alter soft tissue composition and mechanical properties (e.g., ankylosing spondylitis, rheumatoid arthritis, amyloidosis, type 1 diabetes)\n* History of two or more mUCLAB reconstruction surgeries (revision reconstructions)\n* History of central or peripheral cardiovascular diseases\n* Any other physical condition that interferes with daily sports training and competition","ALL","18 Years","80 Years",{"count":146,"type":147},80,"ESTIMATED","INTERVENTIONAL",[150],"NA","The goal of this clinical trial is to investigate the correlations between dynamic soft tissue displacement, mechanical properties, and functional recovery across three studies: biceps femoris long head (BFlh) muscle injury, adult acquired flatfoot deformity (AAFD), and medial ulnar collateral ligament anterior bundle (mUCLAB) reconstruction. The main questions it aims to answer are:\n\n1. In athletes with BFlh injury who have returned to sport but remain limited in full participation, does an 8-week Nordic hamstring exercise (NHE) program alter BFlh displacement measured by ultrasound speckle tracking (UST) during maximal eccentric testing and improve eccentric strength?\n2. In adults with flexible AAFD\u002FPCFD, does a 6-week intervention of conservative exercise and custom foot orthoses alter the dynamic mechanical behavior (longitudinal displacement and dynamic torsion tracked by UST) and mechanical properties (shear wave elastography, SWE) of the posterior tibial tendon (PTT)?\n3. In overhead athletes after mUCLAB reconstruction, does an 8-week blood flow restriction (BFR) training program targeting the forearm flexor-pronator mass reduce regional strain quantified by UST and alter the Young's modulus of the reconstructed graft under dynamic valgus stress?\n\nResearchers will compare biomechanical and functional outcomes within participants before and after each intervention, as well as against comparison groups (athletes with full return-to-sport clearance or asymptomatic flatfoot adults), using UST algorithms and SWE. Depending on their allocated cohort, participants will:\n\nPart 1 (Hamstring Muscle Injury):\n\n* Perform an 8-week progressive Nordic hamstring exercise (NHE) program (for the experimental group)\n* Undergo BFlh muscle stiffness assessment using SWE and power Doppler examination for intramuscular scar vascularity\n* Complete pain-free maximal isokinetic eccentric knee flexion tests and isometric contractions combined with UST and surface electromyography (sEMG) to measure muscle displacement, scar gap size, and peak torque\n* Complete hamstring flexibility testing (active knee extension test) and fill out the Functional Assessment Scale for Acute Hamstring Injuries (FASH)\n\nPart 2 (adult acquired flatfoot deformity):\n\n* Receive 6 weeks of conservative intervention consisting of wearing custom-molded foot orthoses (for at least 85% of days) combined with progressive PTT eccentric training, short-foot exercises, and calf stretches\n* Undergo SWE to evaluate proximal and distal PTT shear wave velocity. Perform progressive isometric foot adduction on an isokinetic dynamometer with UST recording raw radiofrequency (RF) data to measure PTT longitudinal displacement and cross-sectional dynamic torsion\n* Complete clinical assessments at baseline, 6 weeks, and 12-week follow-up, including single-leg heel-rise tests, isokinetic strength, ankle range of motion, force-plate balance tests, 5-minute walk tests, and self-reported questionnaires (FFI-R, MSK-HQ)\n\nPart 3 (Elbow Ligament Reconstruction Cohort):\n\n* Participate in an 8-week progressive isokinetic strength training program for the forearm flexor-pronator mass combined with blood flow restriction, alongside grip training\n* Undergo dynamic elbow valgus stress testing at 5 N·m torque on an isokinetic dynamometer synchronized with UST and SWE to evaluate regional strain and Young's modulus of the reconstructed mUCLAB\n* Complete upper-extremity evaluations before and after training, including shoulder-elbow range of motion, isometric muscle strength using hand-held dynamometry, countermovement push-up (CMPU) power tests on force plates, and the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire",[153,154,155],"Adult Acquired Flatfoot","Hamstring Muscle Strain","Ulnar Collateral Ligament Reconstruction",[157,158,159,160],"Soft tissue","Rehabilitation","Physical therapy","Ultrasound speckle tracking","NOT_YET_RECRUITING","2026-10-06",{"date":164,"type":165},"2026-10-13","ACTUAL",{"date":167,"type":147},"2026-11",{"date":169,"type":147},"2028-07",{"name":5,"class":6},1]