Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2026-01-10 @ 5:31 PM
Study NCT ID:
NCT03743857
Status:
COMPLETED
Last Update Posted:
2019-01-29
First Post:
2018-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Improvement of the Ankle Joint Range on Balance in the Elderly.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-26', 'studyFirstSubmitDate': '2018-11-11', 'studyFirstSubmitQcDate': '2018-11-13', 'lastUpdatePostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Test Up and Go', 'timeFrame': 'Change from baseline to day 21', 'description': 'It is a test in which the functional mobility of the participant is measured.'}, {'measure': 'One Leg Balance Test', 'timeFrame': 'Change from baseline to day 21', 'description': 'The time that the participant can be with monopodal support is measured'}, {'measure': 'Functional Reach Test', 'timeFrame': 'Change from baseline to day 21', 'description': 'It measures the ability to move the center of gravity forward without losing balance.'}, {'measure': 'Analysis of Center of Pressure', 'timeFrame': 'Change from baseline to day 21', 'description': 'Measurement of the displacement of the center of pressures using a Pressure Platform.'}], 'secondaryOutcomes': [{'measure': 'Active ankle range of movement', 'timeFrame': 'Change from baseline to day 21', 'description': 'Measurement of the total active joint range of the ankle in discharge with a goniometer.'}, {'measure': 'Weight Bearing Dorsiflexion Lunge Test', 'timeFrame': 'Change from baseline to day 21', 'description': 'Measurement of dorsiflexion of the ankle under load with an inclinometer.'}, {'measure': 'Falls Efficacy Scale', 'timeFrame': 'Change from baseline to day 21', 'description': 'Scale that measures the worry of suffering a fall.'}, {'measure': 'Assessment of ankle plantar flexion muscle strength', 'timeFrame': 'Change from baseline to day 21', 'description': 'Measurement of the strength of the plantar flexion of the ankle with a dynamometer.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ankle', 'Balance', 'Manual Therapy', 'Older Adult'], 'conditions': ['Aging Problems']}, 'descriptionModule': {'briefSummary': 'The effects of aging on the ankle joint will contribute negatively to balance in the elderly. Manual therapy is a technique that is usually used to treat ankle arthrokinematics, although there is little literature on this population. This study seeks to investigate the effects that a mobilization on the ankle will produce in order to improve its joint range and if the balance of the older adult improves after the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 60 years or more\n\nExclusion Criteria:\n\n* Do not sign the consent\n* No acute pathology (3 months)\n* Vestibular pathology\n* CNS disease'}, 'identificationModule': {'nctId': 'NCT03743857', 'acronym': 'ANKLE_ROM', 'briefTitle': 'Effects of Improvement of the Ankle Joint Range on Balance in the Elderly.', 'organization': {'class': 'OTHER', 'fullName': 'University of Valencia'}, 'officialTitle': 'Effects of Improvement of the Ankle Joint Range on Balance in the Elderly: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'DHG03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Manual Therapy', 'description': '6 sessions of ankle manual therapy', 'interventionNames': ['Procedure: Manual Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention'}], 'interventions': [{'name': 'Manual Therapy', 'type': 'PROCEDURE', 'description': 'AP ankle mobilization', 'armGroupLabels': ['Manual Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Universidad de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'David Hernández-Guillén, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Principal Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Valencia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'David Hernández', 'investigatorAffiliation': 'University of Valencia'}}}}