Ulnar Collateral Ligament SprainNCT07485530
Validating the Speckle Tracking Methods on Soft Tissue Strain, Displacement, and Roles in Physical Therapy
A study testing blood flow restriction training and nordic exercise training in people with Ulnar Collateral Ligament Sprain and Tibialis Posterior Dysfunction, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulnar Collateral Ligament Sprain, Tibialis Posterior Dysfunction, Anterior Cruciate Ligament Reconstruction Rehabilitation
- What is being tested?
- blood flow restriction training and nordic exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Taipei, 100025
Ming-Wei Wang, PhD candidate, +886 932939247, d10428001@ntu.edu.tw
About this study
Official title: 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.
Read more
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.
- Conditions
- Ulnar Collateral Ligament Sprain, Tibialis Posterior Dysfunction, Anterior Cruciate Ligament Reconstruction Rehabilitation, Ultrasound Evaluation
- Being tested
- blood flow restriction training, nordic exercise training
- Medical subject headings
- Posterior Tibial Tendon Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood flow restriction trainingOther
The investigators anticipate providing blood flow restriction training to the forearm flexor-pronator muscles of male collegiate baseball pitchers in study 1.
nordic exercise trainingOther
The investigators anticipate providing Nordic hamstring exercise training to ACLR patients in study 3.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study 1: regional strain
Regional strain of the ulnar collateral ligament conducted by ultrasound speckle tracking
Measured: 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
Measured: Day 1
Study 2: tendon torsion
Tendon torsion of the tibialis posterior was conducted by the speckle tracking analysis
Measured: Day 1
Secondary outcomes (6)
Study 1: shear wave speed
Shear wave speed of the ulnar collateral ligament conducted by shear wave elastography
Measured: From enrollment to the end of treatment at 8 weeks
Study 3: shear wave speed
Shear wave speed of the semitendinosus tendon conducted by shear wave elastography
Measured: Day 1
Study 2: shear wave speed
Shear wave speed of the tibialis posterior tendon conducted by hear wave elastography
Measured: Day 1
Study 1: muscle strength
Muscle strength of the flexor-pronator muscles conducted by dynamometer
Measured: From enrollment to the end of treatment at 8 weeks
Study 3: muscle strength
Muscle strength of the semitendinosus muscle conducted by the dynamometer
Measured: Day 1
Stusy 2: muscle strength
Muscle strength of the tibialis posterior muscle conducted by the dynamometer
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulnar Collateral Ligament SprainStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485530
- Sponsor's protocol ID
- 202112174RINA
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating the Speckle Tracking Methods on Soft Tissue Strain, Displacement, and Roles in Physical Therapy: Ligaments (Sports), Tendons (Dysfunction), and Muscles (Exercise Intervention)
- ClinicalTrials.gov ID
- NCT07485530
- Acronym / sponsor ID
- 202112174RINA
- Conditions
- Ulnar Collateral Ligament Sprain, Tibialis Posterior Dysfunction, Anterior Cruciate Ligament Reconstruction Rehabilitation, Ultrasound Evaluation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study 1: male collegiate baseball pitchers; Study 3: ACLR patient | Experimental | Other: blood flow restriction training, Other: nordic exercise trainingStudy 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 |
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood flow restriction trainingThe investigators anticipate providing blood flow restriction training to the forearm flexor-pronator muscles of male collegiate baseball pitchers in study 1. | Other | Study 1: male collegiate baseball pitchers; Study 3: ACLR patient |
| nordic exercise trainingThe investigators anticipate providing Nordic hamstring exercise training to ACLR patients in study 3. | Other | Study 1: male collegiate baseball pitchers; Study 3: ACLR patient |
Primary outcome
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
Study 3: tendon displacement
Time frame: Day 1
Tendon displacement of the semitendinosus tendon was assessed using ultrasound speckle tracking
Study 2: tendon torsion
Time frame: Day 1
Tendon torsion of the tibialis posterior was conducted by the speckle tracking analysis
6 secondary outcomes
Study 1: shear wave speed
Time frame: From enrollment to the end of treatment at 8 weeks
Study 3: shear wave speed
Time frame: Day 1
Study 2: shear wave speed
Time frame: Day 1
Study 1: muscle strength
Time frame: From enrollment to the end of treatment at 8 weeks
Study 3: muscle strength
Time frame: Day 1
Stusy 2: muscle strength
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Ulnar Collateral Ligament Sprain
Not yet recruiting
Correlation Between Soft Tissue Displacement and Functional Performance in Orthopedic Patients
Hamstring Muscle Strain, Adult Acquired Flatfoot Deformity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood flow restriction training and nordic exercise training in people with Ulnar Collateral Ligament Sprain and Tibialis Posterior Dysfunction, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming-Wei Wang, PhD candidate (+886 932939247, d10428001@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study 1: regional strain (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.