Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 4:42 AM
Study NCT ID:
NCT07419750
Status:
COMPLETED
Last Update Posted:
2026-03-24
First Post:
2025-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Muscle Strength and Balance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-23', 'studyFirstSubmitDate': '2025-12-19', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Static Balance Performance-ALFA Stabilometric Platform', 'timeFrame': 'Baseline', 'description': 'Static balance performance will be assessed using the ALFA Stabilometric Platform. A static balance performance score generated by the device software will be recorded separately for each side during the assessment. Higher scores indicate better static balance performance.'}], 'secondaryOutcomes': [{'measure': 'Dynamic Balance Performance-ALFA Stabilometric Platform', 'timeFrame': 'Baseline', 'description': 'Dynamic balance performance will be assessed using the ALFA Stabilometric Platform. The device software calculates an overall dynamic balance performance score based on center of pressure control during a visually guided task. Higher scores indicate better dynamic balance performance.'}, {'measure': 'Isokinetic Muscle Strength', 'timeFrame': 'Baseline', 'description': 'Isokinetic muscle strength will be assessed using an isokinetic dynamometer. Peak torque values of the knee extensor (quadriceps) and flexor (hamstrings), as well as ankle plantar flexor and dorsiflexor muscle groups, will be recorded.'}, {'measure': 'Isokinetic Muscle Endurance', 'timeFrame': 'Baseline', 'description': 'Isokinetic muscle endurance will be assessed using an isokinetic dynamometer. Endurance-related parameters of the knee extensor (quadriceps) and flexor (hamstrings), as well as ankle plantar flexor and dorsiflexor muscle groups, will be recorded during repeated contractions.'}, {'measure': 'Pain Intensity', 'timeFrame': 'Baseline', 'description': 'Pain intensity during activity will be assessed using the Visual Analog Scale (VAS). The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.'}, {'measure': 'Kinesiophobia', 'timeFrame': 'Baseline', 'description': 'Fear of movement will be assessed using the Tampa Scale for Kinesiophobia. The total score ranges from 17 to 68, with higher scores indicating greater fear of movement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'Chronic Ankle Instability, CAI', 'Anterior Cruciate Ligament Injury', 'Muscle Strengh', 'Balance']}, 'descriptionModule': {'briefSummary': 'This study aims to examine the relationship between lower extremity muscle strength and balance and to compare these parameters between healthy individuals and individuals with lower extremity injuries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of adults aged 18-40 years, including individuals with a unilateral anterior cruciate ligament injury, individuals with chronic ankle instability, and healthy controls. Participants with lower extremity injuries will have a confirmed diagnosis within the past 6 to 18 months. All participants will be able to speak, read, and understand Turkish and will voluntarily consent to participate in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAnterior Cruciate Ligament (ACL) Injury Group:\n\n* Aged between 18 and 40 years\n* Diagnosed with a unilateral ACL injury 6 to 18 months prior to participation\n* Diagnosis confirmed by magnetic resonance imaging (MRI)\n* Ability to speak, read, and understand Turkish\n* Willingness to participate voluntarily in the study\n\nChronic Ankle Instability (CAI) Group:\n\n* Aged between 18 and 40 years\n* Diagnosed with chronic ankle instability due to recurrent ankle sprains 6 to 18 months prior to participation\n* History of at least two ankle sprains\n* Ongoing symptoms of functional ankle instability (e.g., episodes of giving way, feelings of instability)\n* Ability to speak, read, and understand Turkish\n* Willingness to participate voluntarily in the study\n\nHealthy Control Group:\n\n* Aged between 18 and 40 years\n* No history of lower extremity injury or orthopedic diagnosis\n* Ability to speak, read, and understand Turkish\n* Willingness to participate voluntarily in the study\n\nExclusion Criteria:\n\n* Presence of neurological, vestibular, or visual disorders that may affect balance\n* History of other orthopedic diseases or trauma\n* Presence of musculoskeletal disorders or cardiovascular comorbidities\n* History of physiotherapy, rehabilitation, or surgical intervention within the past 6 months'}, 'identificationModule': {'nctId': 'NCT07419750', 'briefTitle': 'Relationship Between Muscle Strength and Balance', 'organization': {'class': 'OTHER', 'fullName': 'Biruni University'}, 'officialTitle': 'Relationship Between Muscle Strength and Balance: A Comparison Between Healthy Individuals and Those With Lower Extremity Injuries', 'orgStudyIdInfo': {'id': '19.12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Controls'}, {'label': 'ACL Injury Group'}, {'label': 'CAI Group'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Zeytinburnu', 'country': 'Turkey (Türkiye)', 'facility': 'Biruni University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biruni University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Begum Kara Kaya', 'investigatorAffiliation': 'Biruni University'}}}}