- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07485530
Validating the Speckle Tracking Methods on Soft Tissue Strain, Displacement, and Roles in Physical Therapy
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:
- 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;
- three-dimensional strain, displacement, and rotation of tendons in response to muscle contraction and joint motion are associated with tendon dysfunction; and
- 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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ming-Wei Wang, PhD candidate
- Phone Number: +886 932939247
- Email: d10428001@ntu.edu.tw
Study Locations
-
-
-
Taipei, Taiwan, 100025
- Recruiting
- School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
-
Contact:
- Ming-Wei Wang, PhD candidate
- Phone Number: +886 932939247
- Email: d10428001@ntu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
The investigators anticipate providing blood flow restriction training to the forearm flexor-pronator muscles of male collegiate baseball pitchers in study 1.
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
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
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
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202112174RINA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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