Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT05558202
Status:
COMPLETED
Last Update Posted:
2023-08-02
First Post:
2022-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Turkish Version of The Lower Limb Assessment Score
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007593', 'term': 'Joint Instability'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-01', 'studyFirstSubmitDate': '2022-09-23', 'studyFirstSubmitQcDate': '2022-09-23', 'lastUpdatePostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Lower Limb Assessment Score (LLAS)', 'timeFrame': '10 minutes', 'description': 'The LLAS was designed to test the mobility of many joints of the lower limb in multiple planes of motion. These tests include passive physiological, passive accessory and active range of motion.\n\nThe LLAS is performed on both lower limbs, each providing a score to a maximum of 12.'}, {'measure': 'The Beighton Score', 'timeFrame': '5 minutes', 'description': 'The Beighton Score is a set of manoeuvres used as the standard method of assessment for Generalised Joint Hypermobility. The Beighton score arbitrarily investigates the presence of hyperlaxity (yes = 1, no = 0) at both wrists, the fifth metacarpo-phalangeal joints, elbows, knee joints, and the lumbosacral spine. The items are summed and yield a Beighton score ranging from 0 to 9 points.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypermobility, Joint']}, 'descriptionModule': {'briefSummary': 'Hypermobility is more than normal joint laxity, mobility, and range of motion. It is characterized by increased laxity and fragility of connective tissues. Symptoms from hypermobility can begin at any age and affect women more than men. People are at higher risk than other people. It is stated that hypermobility is an important factor in orthopedic injuries and diseases. Individuals with hypermobility have more frequent orthopedic complaints and the problems are usually idiopathic and chronic. Studies have reported that proprioception and musculoskeletal reflex function may be affected independently of symptoms in hypermobile individuals. Therefore, evaluating hypermobility is very important in preventing hypermobility-related problems and injuries and developing appropriate treatment methods. Although the Beighton score is the most commonly used scoring method to determine hypermobility, it may be insufficient to determine hypermobility of the lower extremities. The Lower Limb Assessment Score (LLAS) has been reported to be one of the most appropriate scoring methods for assessing lower extremity hypermobility in the literature. The aim of this study is to adapt LLAS to Turkish and measure its validity and reliability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '\\- The study will be carried out by young adults and adults in the Kutahya Health Science University', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n* Aged between 18 to 35\n\nExclusion Criteria:\n\n* Using assistive devices or orthoses for the upper extremity\n* Surgery history of the upper extremity\n* Pain located on the upper extremity in the last 6 months\n* Previous trauma that might restrict normal range of motion.\n* Having degenerative or inflamatuar disease'}, 'identificationModule': {'nctId': 'NCT05558202', 'briefTitle': 'Turkish Version of The Lower Limb Assessment Score', 'organization': {'class': 'OTHER', 'fullName': 'Kutahya Health Sciences University'}, 'officialTitle': 'Turkish Version of The Lower Limb Assessment Score : Reliability and Validity', 'orgStudyIdInfo': {'id': 'LLAS Study'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Turkish validity and reliability', 'type': 'OTHER', 'description': '1. Explanation of the Turkish version of the scale.\n2. Translating the Turkish version of the scale into English to ensure consistency with the original scale.\n3. First application of scales to participants by two examiners separately.\n4. Second application of the scales to the participants by one examiner.\n5. Statistical analysis and scaling'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kütahya', 'country': 'Turkey (Türkiye)', 'facility': 'Kutahya Health Science University', 'geoPoint': {'lat': 39.42417, 'lon': 29.98333}}], 'overallOfficials': [{'name': 'Emrah Afsar, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kutahya Health Sciences University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kutahya Health Sciences University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Occupational Therapy Deparment', 'investigatorFullName': 'Emrah Afsar', 'investigatorAffiliation': 'Kutahya Health Sciences University'}}}}