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

NCT07485530 | Recruiting

• 1 other identifier: 202112174RINA
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.three-dimensional strain, displacement, and rotation of tendons in response to muscle contraction and joint motion are associated with tendon dysfunction; and
3. 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.

Conditions

Ulnar Collateral Ligament Sprain; Tibialis Posterior Dysfunction; Anterior Cruciate Ligament Reconstruction Rehabilitation; Ultrasound Evaluation

Outcome Measures

Primary Outcomes (3)

• Study 1: regional strain

  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

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

  Day 1

• Study 2: tendon torsion

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

  Day 1

Secondary Outcomes (6)

• Study 1: shear wave speed

  From enrollment to the end of treatment at 8 weeks

• Study 3: shear wave speed

  Day 1

• Study 2: shear wave speed

  Day 1

• Study 1: muscle strength

  From enrollment to the end of treatment at 8 weeks

• Study 3: muscle strength

  Day 1

Study Arms (2)

Study 1: male collegiate baseball pitchers; Study 3: ACLR patient

EXPERIMENTAL

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; Other: nordic exercise training

Study 1: male collegiate baseball pitchers ; Study 2: TP dysfunction patient; Study 3: ACLR patient

NO INTERVENTION

Study 1: healthy male collegiate baseball pitchers control group; Study 2: TP dysfunction patient; Study 3: ACLR patient

Interventions

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.

Study 1: male collegiate baseball pitchers; Study 3: ACLR patient

nordic exercise training OTHER

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

Study 1: male collegiate baseball pitchers; Study 3: ACLR patient

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

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

Taipei, 100025, Taiwan

RECRUITING

MeSH Terms

Conditions

Posterior Tibial Tendon Dysfunction

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Foot Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Ming-Wei Wang, PhD candidate

CONTACT

+886 932939247; d10428001@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 20, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)