Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-29 @ 8:01 PM
Study NCT ID:
NCT07037095
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-25
First Post:
2025-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Gastrocnemius Muscle Strain and Functional Performance in Footballers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013180', 'term': 'Sprains and Strains'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2025-06-17', 'studyFirstSubmitQcDate': '2025-06-17', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lower Extremity Functional Scale (LEFS)', 'timeFrame': '6 Month', 'description': "The Lower Extremity Functional Scale (LEFS) is a questionnaire used to assess an individual's functional limitations related to their lower extremities. It contains 20 items, each scored on a scale of 0 to 4, with higher scores indicating better function. The total score ranges from 0 to 80, with 80 representing no functional limitations"}, {'measure': 'Hop tests', 'timeFrame': '6 Months', 'description': "The Hop tests are used to assess lower limb function, particularly after injury, and are scored using the Limb Symmetry Index (LSI) by comparing the injured leg's performance to the uninjured leg. A score of 90% or higher on the LSI is generally considered a satisfactory level of recovery, indicating readiness to return to sports."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Muscle Strain']}, 'descriptionModule': {'briefSummary': 'Footballers are highly prone to lower extremity injuries due to the intense physical demands of the sport, with calf muscle strains, particularly gastrocnemius injuries, being very common. The gastrocnemius muscle plays a critical role in movement, posture, and athletic performance.', 'detailedDescription': 'This study aims to determine the correlation between the severity of gastrocnemius muscle strain and functional performance among footballers. Participants aged 18-40 years with clinically diagnosed gastrocnemius strains were assessed using the Lower Extremity Functional Scale (LEFS) and Hop Test. Severity was categorized through physical examination techniques like palpation, passive dorsiflexion stretch, and resisted plantarflexion tests. Data analysis will explore the relationship between strain severity and functional outcomes, providing valuable insights into rehabilitation strategies and return to play decisions for injured athletes. This study addresses a research gap by focusing specifically on footballers and correlating strain severity with sport-specific functional performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Footballers are highly prone to lower extremity injuries due to the intense physical demands of the sport, with calf muscle strains, particularly gastrocnemius injuries, being very common.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both male and female patients aged between 18 and 40 years.\n* At least six months of football training.\n* The study focused on players with gastrocnemius muscle injury injuries diagnosed by physical examination; palpation, Stretch Test (Passive Dorsiflexion Test), Resisted Plantarflexion Test.\n* Willing to provide written informed consent and comply with study protocols.\n\nExclusion Criteria:\n\n* Players with Achilles tendon injuries were excluded from the study.\n* History of extrinsic trauma\n* soleus or other calf injury not meeting inclusion conditions\n* Inability to perform rehabilitation\n* No intention to return to full sports act'}, 'identificationModule': {'nctId': 'NCT07037095', 'briefTitle': 'Correlation Between Gastrocnemius Muscle Strain and Functional Performance in Footballers', 'organization': {'class': 'OTHER', 'fullName': 'Superior University'}, 'officialTitle': 'Correlation Between Gastrocnemius Muscle Strain and Functional Performance in Footballers', 'orgStudyIdInfo': {'id': 'DPT/Batch-Fall20/1005'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ankle plantar flexion test', 'interventionNames': ['Diagnostic Test: Ankle plantar flexion test:']}], 'interventions': [{'name': 'Ankle plantar flexion test:', 'type': 'DIAGNOSTIC_TEST', 'description': 'Ankle plantarflexion is valid test used to assess for gastrocnemius muscle strain . Patient is asked to actively plantarflex the foot against resistance while examiner Observe ,this action activates the gastrocnemius muscle .The reliability for ankle plantar flexion is 0.81 to 0.99. If the patient reports pain in the region of gastrocnemius, the test is positive. If there is no pain , weakness or difficulty performing plantarflexion then suggest that test is negative.', 'armGroupLabels': ['Ankle plantar flexion test']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'country': 'Pakistan', 'facility': 'Superior university support club', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Superior University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammad Naveed Babur', 'investigatorAffiliation': 'Superior University'}}}}