Correlation Between Soft Tissue Displacement and Functional Performance in Orthopedic Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNational Taiwan University Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Nordic Hamstring Exercise Training

    Behavioral

    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

    Behavioral

    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

    Other intervention

    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).

Treatment groups

80 Participants
are divided into 3 treatment groups
Group A: Athletes with BFlh Strain with Limited ReturnExperimental treatment 1 intervention
Group B: Adults with Symptomatic Adult Aquired Flatfoot DeformityExperimental treatment 1 intervention
Group C: Overhead Athletes with Post-mUCL ReconstructionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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°/s maximal pain-free isokinetic eccentric knee flexion task.

Time frame
Baseline and Week 8 post-intervention
2

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.

Time frame
Baseline, Week 6 (post-intervention), and Week 12 (follow-up)
3

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.

Time frame
Baseline and Week 8 post-intervention

Secondary outcomes

1

Eccentric Knee Flexor Peak Torque (Arm 1)

Maximal eccentric knee flexor peak torque (N·m) evaluated at 20°/s isokinetic velocity using an isokinetic dynamometer (Biodex Medical Systems, NY, USA) across a range of 90° to 0° knee flexion.

Time frame
Baseline and Week 8 post-intervention
2

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.

Time frame
Baseline and Week 8 post-intervention
3

Long Head of Biceps Femoris Muscle Shear Wave Velocity (Arm 1)

Resting muscle stiffness quantified as shear wave velocity (m/s) at the suspected BFlh injury site and adjacent regions (1 cm proximal and distal) using shear wave elastography with a curved transducer.

Time frame
Baseline and Week 8 post-intervention
4

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).

Time frame
Baseline and Week 8 post-intervention

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University Status unavailable 10055, Taipei City, TaipeiTaiwanTaiwan

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