Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT03600402
Status:
COMPLETED
Last Update Posted:
2019-01-04
First Post:
2018-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects and Dose-response of Manual Therapy in the ROM of the Ankle in Older People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-03', 'studyFirstSubmitDate': '2018-06-07', 'studyFirstSubmitQcDate': '2018-07-16', 'lastUpdatePostDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Active ankle range of movement', 'timeFrame': 'Change from baseline to day 1, 3, 5, 8, 10, 12, 19 and 48', 'description': 'Measurement of the anterior tilt of the tibia during weight bearing with an inclinometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ROM', 'Manual Therapy', 'Mobilization', 'Ankle'], 'conditions': ['Aging Problems']}, 'referencesModule': {'references': [{'pmid': '31944252', 'type': 'DERIVED', 'citation': 'Hernandez-Guillen D, Blasco JM. A Randomized Controlled Trial Assessing the Evolution of the Weight-Bearing Ankle Dorsiflexion Range of Motion Over 6 Sessions of Talus Mobilizations in Older Adults. Phys Ther. 2020 Apr 17;100(4):645-652. doi: 10.1093/ptj/pzaa003.'}]}, 'descriptionModule': {'briefSummary': 'Limitations of the joint range of the ankle in elderly people is usually common. One of the ways to treat this limitation is through manual therapy, although the effects it produces in dose-response terms are still not well understood. Because of this, this work on the one hand aims to determine the effects and effectiveness of manual therapy and, on the other hand, determine the dose-response necessary for the range of motion of the ankle to improve when applying techniques of manual therapy on the ankle in the older adult.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\n* Ankle dorsiflexion limitation\n\nExclusion Criteria:\n\n* Do not sign the consent\n* No injuries in the foot\n* No acute pathology (3 months) in lower limb'}, 'identificationModule': {'nctId': 'NCT03600402', 'acronym': 'ANKLE_ROM', 'briefTitle': 'Effects and Dose-response of Manual Therapy in the ROM of the Ankle in Older People', 'organization': {'class': 'OTHER', 'fullName': 'University of Valencia'}, 'officialTitle': 'Effects and Dose-response of Manual Therapy in the ROM of the Ankle in Older People: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'DHG02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'interventionNames': ['Other: Experimental']}, {'type': 'OTHER', 'label': 'Control Group', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Experimental', 'type': 'OTHER', 'description': '6 sessions of ankle manual therapy', 'armGroupLabels': ['Experimental Group']}, {'name': 'Control', 'type': 'OTHER', 'description': '6 sessions of placebo intervention', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'University of Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'David Hernández, 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'}}}}