Validating the Speckle Tracking Methods on Soft Tissue Strain, Displacement, and Roles in Physical Therapy

March 16, 2026 updated by: National Taiwan University Hospital

Validating the Speckle Tracking Methods on Soft Tissue Strain, Displacement, and Roles in Physical Therapy: Ligaments (Sports), Tendons (Dysfunction), and Muscles (Exercise Intervention)

This three-year research project aims to test the hypothesis that strain and displacement characteristics of human soft tissues are influenced by (1) habitual physical activity, (2) functional impairment, and (3) training interventions. Over the three years, the ulnar collateral ligament of the elbow, the ankle tendon, and the hamstring muscles will be investigated sequentially. Ultrasound speckle-tracking techniques will be employed to verify these hypotheses and to provide a basis for clinical risk assessment of injury, development of therapeutic strategies, and evaluation of rehabilitation outcomes.

In the first year, strain and displacement of the medial ulnar collateral ligament (MUCL) in both longitudinal and transverse directions during passive isokinetic elbow valgus loading will be analyzed in baseball pitchers at high and low injury risk and in healthy controls. The results will be compared with ultrasonic shear-wave elastography. Participants will then undergo an 8-week low- to moderate-intensity blood-flow restriction resistance training program. This phase is expected to characterize ligament mechanical adaptations to long-term sports training, elucidate the relationship between such adaptations and injury risk, and evaluate the effects of resistance training on enhancing medial elbow joint stability.

In the second year, individuals with posterior tibial tendon dysfunction and healthy controls will be examined. Longitudinal strain and displacement, as well as transverse rotation and displacement of the tibialis posterior tendon during active ankle movements will be quantified and compared with shear-wave elastography measurements. These results are expected to clarify the relationship between tendon strain-displacement behavior and tendon dysfunction, provide mechanistic insights into tendon pathology, and inform optimal therapeutic strategies.

In the third year, patients following anterior cruciate ligament (ACL) reconstruction will be investigated. Longitudinal strain and displacement of the hamstring graft donor site, specifically the semitendinosus muscle-tendon unit, following eccentric training will be assessed and compared with shear-wave elastography and electromyography. This phase is expected to characterize post-harvest semitendinosus muscle activity patterns and their associations with postoperative muscle strength deficits.

By integrating findings across the three phases, the anticipated clinical implications of this project include determining whether:

  1. adaptive responses of ligaments to repetitive tensile loading during long-term sports participation (including strain behavior and mechanical properties) can serve as screening indicators for injury risk, and evaluating the effects of blood-flow restriction resistance training in these populations;
  2. three-dimensional strain, displacement, and rotation of tendons in response to muscle contraction and joint motion are associated with tendon dysfunction; and
  3. strain and displacement characteristics of the semitendinosus muscle (in relation to muscle recruitment) can be improved through postoperative functional training following its use as a graft source.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100025
        • Recruiting
        • School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Study 1

  • male pitchers aged between 18 and 35 years
  • more than five years of pitching experience
  • at least 200 counts of pitching training per week

Study 2

  • Age between 20 and 65 years
  • diagnosed with grade II posterior tibial tendon dysfunction and recommended by a physician for surgical intervention

Study 3

  • The participants were between 18 and 45 years old
  • had undergone unilateral anterior cruciate ligament semitendinosus tendon autograft reconstruction surgery within the past 6 years
  • were able to fully participate in the sports and training they had before their injury

Exclusion Criteria:

Study 1

  • diagnosed with partial or full thickness tears of the UCL by arthrographic/ nonarthrographic MR techniques in past medical records
  • having a positive result in the "moving valgus stress test" screening24
  • unable to participate in regular baseball pitching training or absent from the competition during the March 2023 to March 2025 season
  • found to show suspicious signs, such as hypoechoic foci and calcification, which suggest UCL injury under ultrasound screening4
  • with a <80% compliance rate in the eight-week BFRT

Study 2

  • The lower extremities have undergone surgical intervention
  • The lower extremities have a known history of nerve or vascular injury
  • The ankles and feet have known ligament tears
  • Fixed deformities of the foot joints
  • The patient has a known physical condition that would affect the conduct of the experiment

Study 3

  • Having any orthopedic condition that prevents them from participating in the competition, such as arthritis or knee pain
  • having a history of hamstring muscle strain in the knee within the past 3 months
  • having an attendance rate of less than 80% in the subsequent eight weeks of training

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study 1: male collegiate baseball pitchers; Study 3: ACLR patient
Study 1: Male collegiate baseball pitchers receiving 8 weeks of blood flow restriction training of their forearm flexor-pronator muscles Study 3: ACLR patient receiving 8 weeks of Nordic exercise training
Other: blood flow restriction training
The investigators anticipate providing blood flow restriction training to the forearm flexor-pronator muscles of male collegiate baseball pitchers in study 1.
Other: nordic exercise training
The investigators anticipate providing Nordic hamstring exercise training to ACLR patients in study 3.
No Intervention: Study 1: male collegiate baseball pitchers ; Study 2: TP dysfunction patient; Study 3: ACLR patient
Study 1: healthy male collegiate baseball pitchers control group; Study 2: TP dysfunction patient; Study 3: ACLR patient

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Study 1: regional strain
Time Frame: From enrollment to the end of treatment at 8 weeks
Regional strain of the ulnar collateral ligament conducted by ultrasound speckle tracking
From enrollment to the end of treatment at 8 weeks
Study 3: tendon displacement
Time Frame: Day 1
Tendon displacement of the semitendinosus tendon was assessed using ultrasound speckle tracking
Day 1
Study 2: tendon torsion
Time Frame: Day 1
Tendon torsion of the tibialis posterior was conducted by the speckle tracking analysis
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Study 1: shear wave speed
Time Frame: From enrollment to the end of treatment at 8 weeks
Shear wave speed of the ulnar collateral ligament conducted by shear wave elastography
From enrollment to the end of treatment at 8 weeks
Study 3: shear wave speed
Time Frame: Day 1
Shear wave speed of the semitendinosus tendon conducted by shear wave elastography
Day 1
Study 2: shear wave speed
Time Frame: Day 1
Shear wave speed of the tibialis posterior tendon conducted by hear wave elastography
Day 1
Study 1: muscle strength
Time Frame: From enrollment to the end of treatment at 8 weeks
Muscle strength of the flexor-pronator muscles conducted by dynamometer
From enrollment to the end of treatment at 8 weeks
Study 3: muscle strength
Time Frame: Day 1
Muscle strength of the semitendinosus muscle conducted by the dynamometer
Day 1
Stusy 2: muscle strength
Time Frame: Day 1
Muscle strength of the tibialis posterior muscle conducted by the dynamometer
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202112174RINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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