Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT07084220
Status:
COMPLETED
Last Update Posted:
2025-07-24
First Post:
2025-07-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Cognitive Tasks on Single Limb Balance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2025-07-16', 'studyFirstSubmitQcDate': '2025-07-16', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Balance', 'timeFrame': '30 second trials', 'description': 'Force plate derived measures (center of pressure and time to boundary) will be collected.'}], 'secondaryOutcomes': [{'measure': 'Cognitive errors', 'timeFrame': '30 seconds', 'description': 'The number of cognitive errors during cognitive tasks.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dual-task', 'ankle', 'balance'], 'conditions': ['Chronic Ankle Instability, CAI', 'Healthy Participants']}, 'referencesModule': {'references': [{'pmid': '20195021', 'type': 'BACKGROUND', 'citation': 'Rahnama L, Salavati M, Akhbari B, Mazaheri M. Attentional demands and postural control in athletes with and without functional ankle instability. J Orthop Sports Phys Ther. 2010 Mar;40(3):180-7. doi: 10.2519/jospt.2010.3188.'}]}, 'descriptionModule': {'briefSummary': 'Purpose of the Study: The purpose of this study is to evaluate the effects of performing various cognitive tasks on balance in individuals with chronic ankle instability and healthy controls. Three different cognitive tasks will be performed while participants balance on one limb. Chronic ankle instability is defined as having a history of at least one ankle sprain and having residual effects. The specific aims of this study are to:\n\n1. Determine if performing the cognitive tasks effect single limb balancing.\n2. Determine which cognitive task, if any, has the greatest effect on single limb balance.\n\nParticipants will perform single-limb balancing with eyes open on the force plate while performing one of the four cognitive tasks. You will start with the control condition, the order of cognitive tasks will be random. Testing will occur on both limbs.\n\n1. Each trial will last 1 minute. There will be at least a 30 second rest period between trials.\n2. You will perform 3 trials of each cognitive task prior to moving on to the next task. There will be a 5 minute rest between cognitive tasks.\n3. You will complete all testing on one limb (counterbalanced) prior to moving to the other limb.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'University and surrounding community', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18-40 years old\n* Lower extremity injury-free for at least 3 months\n* No previous history of foot or ankle surgery on either limb\n* No known history of known foot or ankle fracture on either limb\n* No known neurological or vestibular disorders, or other medical conditions affecting balance, including ear infections\n* Does not have diabetes mellitus\n* No self-reported disability due to lower extremity pathology\n* No previous history of ankle sprain on either limb as reported on the Modified Ankle Instability Index questionnaire\n* A score lower than 10 on the Identification of Functional Ankle Instability questionnaire\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07084220', 'briefTitle': 'The Effect of Cognitive Tasks on Single Limb Balance', 'organization': {'class': 'OTHER', 'fullName': 'Towson University'}, 'officialTitle': 'The Effect of Cognitive Tasks on Single Limb Balance', 'orgStudyIdInfo': {'id': '1907054099'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy control', 'description': '* No previous history of ankle sprain on either limb\n* A score lower than 10 on the Identification of Functional Ankle Instability\n* Between 18-40 years old\n* Lower extremity injury-free for at least 3 months\n* No previous history of foot or ankle surgery on either limb\n* No known history of known foot or ankle fracture on either limb\n* No known neurological or vestibular disorders, or other medical conditions affecting balance, including ear infections\n* Does not have diabetes mellitus\n* No self-reported disability due to lower extremity pathology'}, {'label': 'Chronic ankle instability', 'description': '* Between 18-40 years old\n* Lower extremity injury-free for at least 3 months\n* No previous history of foot or ankle surgery on either limb\n* No known history of known foot or ankle fracture on either limb\n* No known neurological or vestibular disorders, or other medical conditions affecting balance, including ear infections\n* Does not have diabetes mellitus\n* No self-reported disability due to lower extremity pathology\n* A previous history of at least 1 lateral ankle sprain as reported on the Modified Ankle Instability Index\n* A score of 10 or higher on the Identification of Functional Ankle Instability'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21252', 'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'facility': 'Burdick Hall', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}], 'overallOfficials': [{'name': 'Lisa Custer, Ph.D, ATC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Towson University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Beginning 1 year after publication with no end date', 'ipdSharing': 'YES', 'description': 'Data is available upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Towson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Lisa Custer', 'investigatorAffiliation': 'Towson University'}}}}