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NCT Number: NCT07485530

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University

Taipei, 100025, Taiwan

Location status: Recruiting

Location contact

Ming-Wei Wang, PhD candidate

CONTACT

[email protected]

+886 932939247

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Flow Restriction training

Other

The investigators anticipate providing blood flow restriction training to the forearm flexor-pronator muscles of male collegiate baseball pitchers in study 1.

nordic exercise training

Other

The investigators anticipate providing Nordic hamstring exercise training to ACLR patients in study 3.

Primary outcomes

  1. 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

  2. Study 3: tendon displacement

    Time frame: Day 1

    Tendon displacement of the semitendinosus tendon was assessed using ultrasound speckle tracking

  3. Study 2: tendon torsion

    Time frame: Day 1

    Tendon torsion of the tibialis posterior was conducted by the speckle tracking analysis

Secondary outcomes

  1. 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

  2. Study 3: shear wave speed

    Time frame: Day 1

    Shear wave speed of the semitendinosus tendon conducted by shear wave elastography

  3. Study 2: shear wave speed

    Time frame: Day 1

    Shear wave speed of the tibialis posterior tendon conducted by hear wave elastography

  4. 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

  5. Study 3: muscle strength

    Time frame: Day 1

    Muscle strength of the semitendinosus muscle conducted by the dynamometer

  6. Stusy 2: muscle strength

    Time frame: Day 1

    Muscle strength of the tibialis posterior muscle conducted by the dynamometer

Study contacts

Contact information is provided by the study sponsor or research team.

Ming-Wei Wang, PhD candidate

CONTACT

[email protected]

+886 932939247

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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