Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-27 @ 1:35 AM
Study NCT ID:
NCT03443050
Status:
COMPLETED
Last Update Posted:
2019-03-07
First Post:
2018-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Training on Unstable Surfaces and Effects on the Balance of Healthy Young People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-06', 'studyFirstSubmitDate': '2018-02-07', 'studyFirstSubmitQcDate': '2018-02-16', 'lastUpdatePostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Jumping sideways test', 'timeFrame': 'change from baseline to end of intervention (4weeks)', 'description': 'Test of agility. Evaluates motor coordination under the pressure of time of implementation. The jumps in 15 seconds are recorded'}, {'measure': 'T-agility test', 'timeFrame': 'change from baseline to end of intervention (4weeks)', 'description': 'Evaluation of the performance of the change of direction, as well as the speed and power of the lower extremities'}], 'primaryOutcomes': [{'measure': 'Y-balance test', 'timeFrame': 'change from baseline to end of intervention (4weeks)', 'description': 'Dynamic balance. The maximum length in cm achieved for each leg in the anterior, posterior-lateral and medial-lateral positions will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Posturography (1)', 'timeFrame': 'change from baseline to end of intervention (4weeks)', 'description': 'A force T-plate platform will be used to assess posture in terms of sway area (mm2)'}, {'measure': 'Posturography (2)', 'timeFrame': 'change from baseline to end of intervention (4weeks)', 'description': 'A force T-plate platform will be used to assess posture in terms of mean velocity (m/s)'}, {'measure': 'Emery test', 'timeFrame': 'change from baseline to end of intervention (4weeks)', 'description': 'Static balance and proprioception as measured with the eyes closed to keep balance with one leg over an Airex(R) balance pad. The time in seconds will be recorded.'}, {'measure': 'Functional reach', 'timeFrame': 'change from baseline to end of intervention (4weeks)', 'description': 'Test of stability, measured as the distance reached when leaning forward without falling (cm)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the effects on balance and postural control produced by the implementation of a training program that includes work with unstable surfaces in its methods. It also seeks to quantify to what extent the benefits exceed those achieved with a training of similar characteristics, but implemented on a stable surface. An intensive program is proposed, whose target population is young adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy young adults aged between 18 and 30\n\nExclusion Criteria:\n\n* Professional athlete\n* Musculoskeletal injury in the last 12 months (i.e. sprain, bone fracture)\n* Known balance disorders including vertigo, central or vestibular limitations'}, 'identificationModule': {'nctId': 'NCT03443050', 'briefTitle': 'Training on Unstable Surfaces and Effects on the Balance of Healthy Young People', 'organization': {'class': 'OTHER', 'fullName': 'University of Valencia'}, 'officialTitle': 'Training on Unstable Surfaces and Effects on the Balance of Healthy Young People, a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'UNSTABLE_UV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Balance training on unstable surfaces', 'interventionNames': ['Other: Unstable']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Balance training on stable surface', 'interventionNames': ['Other: Stable']}], 'interventions': [{'name': 'Unstable', 'type': 'OTHER', 'otherNames': ['Experimental'], 'description': 'This group will train over unstable surfaces to enhance balance abilities', 'armGroupLabels': ['Experimental']}, {'name': 'Stable', 'type': 'OTHER', 'otherNames': ['Control'], 'description': 'This group will train over stable surface to enhance balance abilities', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'University of Valencia. Facultat de Fisioterapia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Jose M Blasco, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Valencia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Valencia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jose María Blasco Igual', 'investigatorAffiliation': 'University of Valencia'}}}}