- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07513779
Residual Eccentric Strength Deficits and Deep Scar Tissue Thickness in Patients With Tennis Leg
Residual Eccentric Strength Deficits of Gastrocnemius Muscle and Deep Scar Tissue Thickness in Patients With Tennis Leg: A Cross-Sectional Study
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mohamed M ElMeligie, Ph.D
- Phone Number: 01159880001
- Email: mohamed.elmeligie@acu.edu.eg
Study Locations
-
-
Cairo Governorate
-
New Cairo, Cairo Governorate, Egypt, 12345
- Recruiting
- Outpatient clinic of faculty of physical therapy, Alhayah University in Cairo
-
Contact:
- Mohamed M ElMeligie, Ph.D
- Phone Number: 01159880001
- Email: mohamed.elmeligie@acu.edu.eg
-
Principal Investigator:
- Mariam A Wagdy, BSc.
-
Principal Investigator:
- Haitham M Elhafez, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eccentric Plantar Flexor Strength Deficit (Percentage)
Time Frame: Single assessment at the time of enrollment (one study visit)
|
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)
Time Frame: Single assessment at the time of enrollment (one study visit)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Single-Leg Heel Raise Endurance
Time Frame: Single assessment at the time of enrollment (one study visit)
|
Number of single-leg heel raise repetitions performed on each limb until fatigue.
Heel raise height symmetry between limbs is also recorded.
|
Single assessment at the time of enrollment (one study visit)
|
|
Time-to-Fatigue During Repeated Plantar Flexion
Time Frame: Single assessment at the time of enrollment (one study visit)
|
Time (in seconds) to fatigue during repeated single-leg plantar flexion for both the injured and uninjured limbs.
|
Single assessment at the time of enrollment (one study visit)
|
|
Ankle Dorsiflexion Range of Motion
Time Frame: Single assessment at the time of enrollment (one study visit)
|
Passive ankle dorsiflexion range of motion (degrees) measured using a standard universal goniometer, assessing the angle between the foot and tibia in a standardized position.
Restricted dorsiflexion may indicate increased stiffness or altered tissue elasticity due to scar tissue.
Measured bilaterally.
|
Single assessment at the time of enrollment (one study visit)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Haitham M. ElHafez, Ph.D, Cairo University
- Study Director: Aya A Said, Ph.D, Cairo University
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
Other Study ID Numbers
- CUPT-MSc-2026-MARIAMAW-001
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.
Clinical Trials on Tennis Leg
-
Cairo UniversityRecruitingTennis | Tennis Serve PerformanceEgypt
-
National Yang Ming Chiao Tung UniversityRecruitingElite Table Tennis PlayersTaiwan
-
Riphah International UniversityCompletedStruck by Tennis RacquetPakistan
-
Biruni UniversityCompletedHealthy Tennis PlayersTurkey (Türkiye)
-
University of LiegeCompleted
-
Haydarpasa Numune Training and Research HospitalNot yet recruiting
-
Riphah International UniversityCompletedLateral Epicondylitis (Tennis Elbow)Pakistan
-
University of VermontRecruitingLateral Elbow Tendinopathy (Tennis Elbow)United States
Clinical Trials on B-mode Diagnostic Ultrasound - Scar Tissue Assessment
-
University Hospital, BrestCompleted
-
Centre hospitalier de l'Université de Montréal...Canadian Institutes of Health Research (CIHR); Centre de Recherche du Centre...Recruiting
-
Kayseri City HospitalRecruitingLymphedema | LipedemaTurkey (Türkiye)
-
National Cancer Institute, EgyptCompletedWeaning Failure | Successful WeaningEgypt
-
Taipei Medical University WanFang HospitalTaipei Medical UniversityCompleted
-
Tanta UniversityNot yet recruitingAssess the Prediction of Successful SBT and Extubation of Trachea by Bedside Lung Ultrasound in Mechanically Ventilated Patients
-
Assiut UniversityNot yet recruitingDiabete Mellitus | Peripheral (Sensorimotor) Diabetic PolyneuropathyEgypt
-
University of LausanneSwiss National Science Foundation; Swiss Heart Foundation; Swiss Tobacco Prevention...Completed
-
The Netherlands Cancer InstituteUniversity Medical Center GroningenUnknownCardiovascular Diseases | Breast NeoplasmsNetherlands
-
University Hospital, LilleCompletedFluid Overload | Fluid Responsiveness | Venous Congestion | Cardiovascular Surgery | Inferior Vena Cava AbnormalityFrance