Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT05676632
Status:
UNKNOWN
Last Update Posted:
2023-01-09
First Post:
2022-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Achilles Tendon Ruptures: Cross-Sectional Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-15', 'releaseDate': '2025-11-28'}], 'estimatedResultsFirstSubmitDate': '2025-11-28'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-04', 'studyFirstSubmitDate': '2022-11-10', 'studyFirstSubmitQcDate': '2023-01-04', 'lastUpdatePostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ultrasound Tissue Characterisation', 'timeFrame': 'Week 0', 'description': 'Imaging of the Achilles Tendon'}, {'measure': 'Ultrasound Tissue Characterisation', 'timeFrame': 'week 8', 'description': 'Imaging of the Achilles Tendon'}, {'measure': 'Ultrasound Tissue Characterisation', 'timeFrame': 'week 10', 'description': 'Imaging of the Achilles Tendon'}, {'measure': 'Ultrasound Tissue Characterisation', 'timeFrame': '4 months', 'description': 'Imaging of the Achilles Tendon'}, {'measure': 'Ultrasound Tissue Characterisation', 'timeFrame': '6 months', 'description': 'Imaging of the Achilles Tendon'}, {'measure': 'Ultrasound Tissue Characterisation', 'timeFrame': '12 months', 'description': 'Imaging of the Achilles Tendon'}], 'secondaryOutcomes': [{'measure': 'Isometric plantarflexor strength testing', 'timeFrame': 'Week 0, week 8, week 10, 4 months, 6 months and 12 months', 'description': 'Isometric plantarflexor strength will be tested in plantargrade (neutral position) using the fysiometer.'}, {'measure': 'Heel Raise Test', 'timeFrame': 'Week 0, week 8, week 10, 4 months, 6 months and 12 months', 'description': 'The heel raise test will measure the amount of heel raises and the work completed by the participant in joules.'}, {'measure': 'Achilles Tendon Rupture Score (ATRS)', 'timeFrame': 'Week 0, week 8, week 10, 4 months, 6 months and 12 months', 'description': 'Scores are between 0-100 with a higher score indicating less severe limitations'}, {'measure': 'EuroQol- 5 Dimension - 5 Level (EQ-5D-5L)', 'timeFrame': 'Week 0, week 8, week 10, 4 months, 6 months and 12 months', 'description': 'An index score is produced which is calculated using the UK index score reference. The thermometer score is between 0-100 with a higher score indicating better perceived health'}, {'measure': 'Tampa Scale of Kinesiophobia (TSK)', 'timeFrame': 'Week 0, week 8, week 10, 4 months, 6 months and 12 months', 'description': 'The total score of the scale range from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Week 0, week 8, week 10, 4 months, 6 months and 12 months', 'description': 'The two domains (anxiety and depression) provide scores between 0-21 with a higher score indicating higher severity'}, {'measure': 'International Physical Activity Questionnaire - Short Form (IPAQ-SF)', 'timeFrame': 'Week 0, week 8, week 10, 4 months, 6 months and 12 months', 'description': 'Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or MET minutes representing the amount of energy expended carrying out'}, {'measure': 'Pain Catastrophizing Scale (PCS)', 'timeFrame': 'Week 0, week 8, week 10, 4 months, 6 months and 12 months', 'description': 'A total score is calculated from 0-54 with a higher score indicating higher pain catastrophising'}, {'measure': '36-Item Short Form Survey (SF-36)', 'timeFrame': 'Week 0, week 8, week 10, 4 months, 6 months and 12 months', 'description': 'SF-36 measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). Higher scores indicate higher quality of life'}, {'measure': 'Accelerometer', 'timeFrame': 'Week 0, week 8, week 10, 4 months, 6 months and 12 months', 'description': 'GENEactiv wrist based accelerometer measuring total steps, activity intensity. 24 hours data capture for 7 days'}, {'measure': 'Accelerometer', 'timeFrame': 'Week 0, week 8, week 10, 4 months, 6 months and 12 months', 'description': 'GENEactiv wrist based accelerometer measuring sleep duration for 7 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Achilles Tendon Rupture']}, 'referencesModule': {'references': [{'pmid': '41313926', 'type': 'DERIVED', 'citation': "Briggs-Price S, Yates T, Mangwani J, Bhatia M, Jones A, Mielcarek K, Solaini A, Leung SY, Gravare Silbernagel K, Hebert-Losier K, de Vos RJ, Millar NL, Vicenzino B, O'Neill S. Structure and function of the Achilles tendon and plantarflexors after non-surgical management of Achilles tendon rupture: A cross-sectional study. Musculoskelet Sci Pract. 2025 Nov 25;81:103459. doi: 10.1016/j.msksp.2025.103459. Online ahead of print."}]}, 'descriptionModule': {'briefSummary': 'This project will assess the clinical outcomes of individuals completing rehabilitation for their Achilles tendon rupture at the University Hospitals of Leicester. Patients attending the Achilles tendon rupture clinic or rehabilitation classes will be asked to complete ultrasound imaging, strength testing and questionnaires. This will provide an insight into the rehabilitation outcomes of a broad range of patients at each rehabilitation timepoint.', 'detailedDescription': 'This study will measure the recovery of participants following Achilles tendon rupture. Measurements will capture individual participants at each rehabilitation time point following Achilles tendon rupture. These time points include following rupture (week 0), after 8 weeks, 10 weeks, 4 months, 6 months and 1 year. The measurements include an ultrasound tissue characterisation scan, isometric (static) strength test and heel raise test. In addition questionnaires will be completed by participants at each time point. Questionnaires include the Achilles Tendon Rupture Score, Hospital Anxiety and Depression Scale, EQ5D (a health related quality of life measure), International Physical Activity Questionnaire, Tampa Scale for Kinesiophobia and the Pain Catastrophising Scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals attending the Achilles tendon rupture clinic following Achilles tendon rupture', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to provide informed consent\n* 16 years of age or above\n\nExclusion Criteria:\n\n* Inability to provide informed consent due to cognitive impairment\n* Inability to provide informed consent as unable to understand sufficient English'}, 'identificationModule': {'nctId': 'NCT05676632', 'briefTitle': 'Impact of Achilles Tendon Ruptures: Cross-Sectional Analysis', 'organization': {'class': 'OTHER', 'fullName': 'University of Leicester'}, 'officialTitle': 'The Impact of Achilles Tendon Rupture on the Structure and Function of the Achilles Tendon and Plantarflexors: a Cross Sectional Analysis', 'orgStudyIdInfo': {'id': '0882'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Routine Clinical Care', 'type': 'OTHER', 'description': 'All participants attending the Achilles Tendon Rupture clinic will receive usual clinical care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leicester', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospitals, Leicester', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-11-28', 'type': 'RELEASE'}, {'date': '2025-12-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of Leicester'}}}}