Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-01-01 @ 9:00 AM
Study NCT ID:
NCT03964961
Status:
UNKNOWN
Last Update Posted:
2019-05-28
First Post:
2019-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Functional Massage in Neuromuscular Response.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The physiotherapist who assesses the outcomes is blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-06-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-23', 'studyFirstSubmitDate': '2019-05-23', 'studyFirstSubmitQcDate': '2019-05-23', 'lastUpdatePostDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delay time change', 'timeFrame': '2 minutes before the intervention, and 8 minutes after the intervention', 'description': 'Time between an electric impulse and 10% of the contraction of the muscle that is being excited with an electric impulse, using an electromyography test (miliseconds).'}, {'measure': 'Contraction time change', 'timeFrame': '2 minutes before the intervention, and 8 minutes after the intervention', 'description': 'Time between 10% and 90% of the contraction of the muscle that is being excited with an electric impulse, using an electromyography test (miliseconds).'}, {'measure': 'Sustain time change', 'timeFrame': '2 minutes before the intervention, and 8 minutes after the intervention', 'description': 'time between 50% of the contraction and 50% of the relaxation of the muscle after being impulsed with an electric impulse, using an electromyography test (miliseconds).'}, {'measure': 'Relaxation time change', 'timeFrame': '2 minutes before the intervention, and 8 minutes after the intervention', 'description': 'time between 90% and 50% of the relaxation of the muscle after being impulsed with an electric impulse, using an electromyography test (miliseconds).'}, {'measure': 'Maximal displacement change', 'timeFrame': '2 minutes before the intervention, and 8 minutes after the intervention', 'description': 'Maximal displacement of the muscle after being excited with an electric impulse, using an electromyography test (miliseconds).'}, {'measure': 'Stiffness change', 'timeFrame': '5 minute before the intervention, and 5 minute after the intervention', 'description': 'Resistance to an external force that deforms its initial shape, using a "Myoton" (N/m).'}, {'measure': 'Elasticity change', 'timeFrame': '5 minute before the intervention, and 5 minute after the intervention', 'description': 'Capacity to recover its initial shape after the removal of the external force that lead to its deformation, using a "Myoton" (logarithmic decrement of the tissue\'s oscillation).'}, {'measure': 'Relaxation change', 'timeFrame': '5 minute before the intervention, and 5 minute after the intervention', 'description': 'Time for a muscle to recover its shape from deformation after the removal of an external force, using a "Myoton" (miliseconds).'}], 'secondaryOutcomes': [{'measure': 'Gastrocnemious strength change', 'timeFrame': '8 minutes before the intervention, and 2 minutes after the intervention', 'description': 'Isometric strength of the gastrocnemious muscles using a handheld dynamometer "microFET 2" (newtons).'}, {'measure': 'Passive ankle dorsiflexion change', 'timeFrame': '6 minutes before the intervention, and 4 minutes after the intervention', 'description': 'Passive range of motion of the ankle dorsiflexion, using an inclinometer (degrees).'}, {'measure': 'Jump height change', 'timeFrame': '10 minutes before the intervention, and 1 minute after the intervention', 'description': 'Maximum jump height with one leg using the application "My Jump 2" (centimeters).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['functional massage', 'conventional massage', 'neuromuscular response'], 'conditions': ['Neuromuscular Diseases']}, 'descriptionModule': {'briefSummary': 'The study compares the effects of two types of massage: a conventional massage and a functional massage, in the neuromuscular response of the gastrocnemious muscles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Exclusion Criteria:\n\n* Muscle injury in the last two months\n* To not understand the study orders\n* Suffer a musculoskeletal disorder that doesn't allow the subject to do the study protocol"}, 'identificationModule': {'nctId': 'NCT03964961', 'briefTitle': 'Effect of Functional Massage in Neuromuscular Response.', 'organization': {'class': 'OTHER', 'fullName': 'Universitat Internacional de Catalunya'}, 'officialTitle': 'Effect of Functional Massage in Gastrocnemious Muscles Neuromuscular Response', 'orgStudyIdInfo': {'id': 'Protocol 6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Functional massage', 'interventionNames': ['Other: Functional massage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional massage', 'interventionNames': ['Other: Conventional massage']}], 'interventions': [{'name': 'Functional massage', 'type': 'OTHER', 'description': "It's a massage combined with a stretching of the muscles.", 'armGroupLabels': ['Functional massage']}, {'name': 'Conventional massage', 'type': 'OTHER', 'description': "It's a regular massage made with the therapist's hands.", 'armGroupLabels': ['Conventional massage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08195', 'city': 'Sant Cugat del Vallès', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Universitat Internacional de Catalunya', 'geoPoint': {'lat': 41.47063, 'lon': 2.08611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat Internacional de Catalunya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Albert Pérez Bellmunt', 'investigatorAffiliation': 'Universitat Internacional de Catalunya'}}}}