Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-02-22 @ 3:56 PM
Study NCT ID:
NCT02469506
Status:
TERMINATED
Last Update Posted:
2017-09-06
First Post:
2015-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuromuscular Electrical Stimulation During Immobilization Due to Ankle Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Minimal to no inclusion.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-04', 'studyFirstSubmitDate': '2015-06-04', 'studyFirstSubmitQcDate': '2015-06-08', 'lastUpdatePostDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage change in calf muscle cross sectional area', 'timeFrame': 'Baseline measurements will be performed at the day of the surgical intervention for the ankle fracture. Post measurements will be performed at the last day of the subsequent 2-week period of immobilization with a lower leg cast.', 'description': 'Measured by a single slice CT-scan of the calf muscle.'}], 'secondaryOutcomes': [{'measure': 'Percentage change in type I and II muscle fiber cross sectional area', 'timeFrame': 'Baseline measurements will be performed at the day of the surgical intervention for the ankle fracture. Post measurements will be performed at the last day of the subsequent 2-week period of immobilization with a lower leg cast.', 'description': 'Measured by immunohistochemical analyses of the muscle biopsies.'}, {'measure': 'Percentage change in type I and II muscle fiber satellite cell content', 'timeFrame': 'Baseline measurements will be performed at the day of the surgical intervention for the ankle fracture. Post measurements will be performed at the last day of the subsequent 2-week period of immobilization with a lower leg cast.', 'description': 'Measured by immunohistochemical analyses of the muscle biopsies.'}, {'measure': 'Percentage change in type I and II muscle fiber intramuscular triglyceride content', 'timeFrame': 'Baseline measurements will be performed at the day of the surgical intervention for the ankle fracture. Post measurements will be performed at the last day of the subsequent 2-week period of immobilization with a lower leg cast.', 'description': 'Measured by immunohistochemical analyses of the muscle biopsies.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Immobilization', 'Muscle Disuse Atrophy']}, 'descriptionModule': {'briefSummary': 'Rationale: Situations such as fractures of the lower extremity can necessitate a prolonged period of immobilization in otherwise healthy individuals. Long-term immobilization of the lower extremity has shown to cause significant reductions in skeletal muscle mass, already occurring during the early stages of disuse. Accordingly, feasible strategies for attenuating this loss of muscle during disuse need to be pursued. Local neuromuscular electrical stimulation (NMES) offers such a potential strategy but, as yet, remains untested during prolonged muscle disuse in a clinical setting.\n\nObjective: To investigate whether twice daily local (gastrocnemius/soleus) NMES attenuates muscle loss during 2 weeks of unilateral ankle immobilization.\n\nStudy design: Randomized, parallel (two groups) study design.\n\nStudy population: 30 adults (18-65 y) with any form of closed ankle fractures needing surgical treatment.\n\nIntervention: Twice daily neuromuscular electrical stimulation (NMES) or no intervention.\n\nMain study parameters/endpoints: Primary: Calf muscle (gastrocnemius) cross sectional area (CSA) as determined by CT scan. Secondary: type I and II muscle fiber CSA and SC content, intramuscular triglyceride content and mRNA and protein expression of anabolic signaling proteins.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral closed ankle fracture (Weber type A, B or C)\n* Aged from 18-65 years\n* 18.5 \\< BMI \\< 30 kg/m2\n* Undergoing surgical treatment\n\nExclusion Criteria:\n\n* Additional fractures beside ankle fracture (e.g. multi-trauma following a car accident)\n* Use of oral anticoagulants such as vitamin K-antagonists (e.g. acenocoumarol and fenprocoumon) and direct-acting or new oral anticoagulants (e.g. apixaban, dabigatran and rivaroxaban).\n* Any family history of thrombosis\n* All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis).\n* Myocardial infarction within the last 3 years'}, 'identificationModule': {'nctId': 'NCT02469506', 'acronym': 'ANKL-ES', 'briefTitle': 'Neuromuscular Electrical Stimulation During Immobilization Due to Ankle Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'The Effects of Daily Neuromuscular Electrical Stimulation on Muscle Mass During Long-term Unilateral Ankle Immobilization in Adults With Ankle Fractures', 'orgStudyIdInfo': {'id': 'METC 14-3-050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NMES group', 'description': 'Patients will receive twice daily sessions of neuromuscular electrical stimulation (NMES).', 'interventionNames': ['Device: Neuromuscular Electrical Stimulation (NMES)']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients will receive daily visits by the investigator to check progress.'}], 'interventions': [{'name': 'Neuromuscular Electrical Stimulation (NMES)', 'type': 'DEVICE', 'description': 'The protocol will consist of a warm-up period (5 min), a stimulation period (30min), and a cooling-down period (5min). Stimulation will be provided by an Enraf Nonius TensMed S84 stimulation device.', 'armGroupLabels': ['NMES group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229ER', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Centre', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Luc van Loon, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Luc. J.C. van Loon', 'investigatorFullName': 'Lex Verdijk', 'investigatorAffiliation': 'Maastricht University Medical Center'}}}}