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Starting soon Not applicable

Correlation Between Soft Tissue Displacement and Functional Performance in Orthopedic Patients

NCT07870408 · tracked via the Priya Life Science Taiwan tracker
Phase
Not applicable
Started
2026-11
Last updated
2026-10-13

Condition(s) studied

Adult Acquired FlatfootHamstring Muscle StrainUlnar Collateral Ligament Reconstruction

Investigational drug(s) / intervention(s)

Nordic Hamstring Exercise TrainingCustom Foot Orthoses and Exercise TherapyForearm Blood Flow Restriction Training

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.

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.

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).

Study summary

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:

1. 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?
2. In adults with flexible AAFD/PCFD, 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)?
3. 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?

Researchers 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:

Part 1 (Hamstring Muscle Injury):

* Perform an 8-week progressive Nordic hamstring exercise (NHE) program (for the experimental group)
* Undergo BFlh muscle stiffness assessment using SWE and power Doppler examination for intramuscular scar vascularity
* 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
* Complete hamstring flexibility testing (active knee extension test) and fill out the Functional Assessment Scale for Acute Hamstring Injuries (FASH)

Part 2 (adult acquired flatfoot deformity):

* 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
* 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
* 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)

Part 3 (Elbow Ligament Reconstruction Cohort):

* Participate in an 8-week progressive isokinetic strength training program for the forearm flexor-pronator mass combined with blood flow restriction, alongside grip training
* 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
* 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Part 1 Inclusion Criteria: * Aged between 18 and 40 years * Participatd in regular physical exercise for at least 2.5 hours per week * 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 * 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 * Palpation assessment confirms tenderness isolated to the unilateral biceps femoris long head Exclusion Criteria: * Palpable distinct defect or gap within the injured biceps femoris long head resembling a severe (grade III) muscle tear * Known systemic diseases that may alter soft tissue composition and mechanical properties * Other musculoskeletal injuries of the lower extremity within the past 6 months (e.g., fractures) * History of surgery in the lower extremities * Any lower extremity orthopedic conditions (e.g., knee osteoarthritis, patellofemoral pain) Part 2 Inclusion Criteria: * Aged between 18 and 80 years * Diagnosed with functional or flexible flatfoot and recommended for conservative treatment by a physician * Six-Item Foot Posture Index (FPI-6) score \>= 6, or a navicular drop test (NDT) \> 9 mm. Exclusion Criteria: * Recommended by a physician to undergo surgical treatment * Structural or rigid flatfoot * Posterior tibial tendon rupture or tendinopathy (including acute tenosynovitis or chronic tendinosis) * Presence of chronic ankle instability, or residual symptoms resulting from traumatic foot ligament tear * Other lower-extremity neuromusculoskeletal disorders, trauma with residual symptoms, or history of surgical intervention * Any physical condition that could interfere with the study procedures Part 3 Inclusion Criteria: * Overhead throwing athletes aged between 18 and 35 years * History of unilateral anterior bundle medial ulnar collateral ligament (mUCLAB) reconstruction * Have returned to sports training and competition following reconstruction surgery Exclusion Criteria: * Known systemic diseases that alter soft tissue composition and mechanical properties (e.g., ankylosing spondylitis, rheumatoid arthritis, amyloidosis, type 1 diabetes) * History of two or more mUCLAB reconstruction surgeries (revision reconstructions) * History of central or peripheral cardiovascular diseases * Any other physical condition that interferes with daily sports training and competition

Primary outcome measure(s)

  • Longitudinal Muscle Displacement of the Biceps Femoris Long Head (Arm 1) — Baseline and Week 8 post-intervention
    Longitudinal muscle displacement in millimeters of the middle biceps femoris long head (BFlh) tracked using ultrasound speckle tracking during a 20°/s maximal pain-free isokinetic eccentric knee flexion task.
  • Posterior Tibial Tendon Dynamic Torsion, Tendon Displacement, and Shear Wave Velocity (Arm 2) — Baseline, Week 6 (post-intervention), and Week 12 (follow-up)
    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.
  • Regional Strain of the Reconstructed mUCLAB Graft (Arm 3) — Baseline and Week 8 post-intervention
    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.

Trial sites (1)

FacilityCityRegionStatus
School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University Taipei City Taipei
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07870408 on ClinicalTrials.gov ↗ ← All trials in Taiwan