NCT07513779

Brief Summary

This study investigates the relationship between the thickness of deep scar tissue and residual weakness in the calf muscles of patients who have recovered from a condition known as "tennis leg." Tennis leg is a common calf muscle injury caused by a partial tear of the inner part of the gastrocnemius (calf) muscle at the point where muscle meets tendon. While patients often return to daily activities after healing, many continue to experience hidden weakness in their calf muscles, particularly during activities that require the muscle to lengthen under load (eccentric contractions), such as walking downhill, running, or landing from a jump. This study uses diagnostic ultrasound imaging to measure the thickness of scar tissue that forms inside the muscle after injury. It also uses an isokinetic dynamometer to objectively measure the eccentric (lengthening) strength of the calf muscles. By comparing the injured leg to the uninjured leg in the same person, the study determines whether patients with thicker scar tissue have greater residual strength deficits. The study enrolls adults aged 18 to 40 years who have had a confirmed unilateral calf muscle tear at least 3 months ago and have returned to normal daily activities. No treatment or intervention is provided. All assessments are performed at a single time point. Understanding how scar tissue relates to persistent muscle weakness could help clinicians better predict long-term outcomes, design more effective rehabilitation programs, and make more informed decisions about when patients are ready to return to sport and physical activity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 7, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Completed
Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

5 months

First QC Date

March 31, 2026

Last Update Submit

September 27, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Eccentric Plantar Flexor Strength Deficit (Percentage)

    The percentage difference in eccentric peak torque (Nm) of the plantar flexor muscles between the injured and uninjured limbs, measured using isokinetic dynamometry at 30°/s and 60°/s. Deficit is calculated as: \[(Uninjured - Injured) / Uninjured\] × 100. A higher percentage indicates greater residual weakness.

    Single assessment at the time of enrollment (one study visit)

  • Deep Scar Tissue Thickness (millimeters)

    Maximal thickness of deep scar tissue at the musculotendinous junction of the medial gastrocnemius muscle, measured in millimeters using B-mode diagnostic ultrasound in longitudinal and transverse planes. Measurements are compared with the contralateral uninjured limb. Additional scar characteristics recorded include echogenicity (hypoechoic/mixed/hyperechoic), scar continuity and alignment, presence of adhesions, and pennation angle disruption (if visible).

    Single assessment at the time of enrollment (one study visit)

Secondary Outcomes (3)

  • Single-Leg Heel Raise Endurance

    Single assessment at the time of enrollment (one study visit)

  • Time-to-Fatigue During Repeated Plantar Flexion

    Single assessment at the time of enrollment (one study visit)

  • Ankle Dorsiflexion Range of Motion

    Single assessment at the time of enrollment (one study visit)

Study Arms (1)

Tennis Leg Patients - Post-Healing

Adults aged 18-40 years with a history of unilateral medial gastrocnemius muscle tear (tennis leg, Grade I or Grade II), confirmed by ultrasound, at least 3 months post-injury, who have clinically healed and returned to daily activities. Each participant serves as their own control with the contralateral uninjured limb used for comparison.

Diagnostic Test: B-mode Diagnostic Ultrasound - Scar Tissue AssessmentDiagnostic Test: Isokinetic Dynamometry - Eccentric Plantar Flexor Strength Assessment

Interventions

B-mode diagnostic ultrasound is used to measure deep scar tissue thickness (in millimeters) at the musculotendinous junction of the medial gastrocnemius muscle. Measurements are obtained in both longitudinal and transverse planes at the site of maximal scar thickness. The contralateral uninjured limb is measured for comparison. Assessments are performed by a blinded experienced sonographer using a standardized probe position. This is a diagnostic exposure measurement, not a therapeutic intervention.

Tennis Leg Patients - Post-Healing

Eccentric plantar flexor strength is assessed using an isokinetic dynamometer at angular velocities of 30°/s and 60°/s. Peak torque (Nm) is recorded for both the injured and uninjured limbs. Testing follows a standardized warm-up protocol with randomized testing order and adequate rest between trials. The percentage deficit between limbs is calculated. This is a diagnostic measurement, not a therapeutic intervention.

Tennis Leg Patients - Post-Healing

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients referred from orthopedic clinics to physiotherapy clinics and/or sports rehabilitation centers in Cairo, Egypt, who have a history of unilateral medial gastrocnemius muscle tear (tennis leg) confirmed by diagnostic ultrasound, have completed acute healing (≥3 months post-injury), and have returned to daily activities.

You may qualify if:

  • Age between 18 and 40 years
  • History of unilateral plantar flexor muscle tear (tennis leg) involving the medial gastrocnemius, confirmed by diagnostic ultrasound
  • Ultrasound diagnostic criteria: hypoechoic or anechoic fluid collection between the medial gastrocnemius and soleus muscles, with partial or complete disruption of the normal muscle fiber architecture at the myotendinous junction
  • Grade I (mild strain, \<10% fiber involvement) or Grade II (moderate partial tear, 10-90% fiber involvement) injury
  • At least 3 months post-injury
  • Clinically healed with return to daily activities
  • Ability to perform maximal eccentric plantar flexion as assessed by the Eccentric Heel Raise Test (Single-Leg) (Chen et al., 2009)

You may not qualify if:

  • Bilateral calf injuries
  • Grade III (severe/complete) gastrocnemius muscle rupture
  • Previous Achilles tendon rupture or surgery
  • Previous injuries or surgeries to the lower extremity (other than the index tennis leg injury)
  • Neurological disorders affecting lower limb function
  • Current acute pain or re-injury at the time of assessment
  • Other lower-limb musculoskeletal injuries affecting performance
  • Systemic inflammatory or connective tissue diseases
  • Popliteal cyst rupture
  • Deep vein thrombosis
  • Isolated Achilles tendon rupture
  • Muscle tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Alhayah University in Cairo

New Cairo, Cairo Governorate, 12345, Egypt

Location

Study Officials

  • Haitham M. ElHafez, Ph.D

    Cairo University

    STUDY CHAIR
  • Aya A Said, Ph.D

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator of Physical Therapy

Study Record Dates

First Submitted

March 31, 2026

First Posted

April 7, 2026

Study Start

April 15, 2026

Primary Completion

September 15, 2026

Study Completion

September 15, 2026

Last Updated

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations