Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-31 @ 3:03 PM
Study NCT ID:
NCT00432705
Status:
COMPLETED
Last Update Posted:
2009-07-22
First Post:
2007-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Unstable Ankles After Balance Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D016512', 'term': 'Ankle Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-21', 'studyFirstSubmitDate': '2007-02-06', 'studyFirstSubmitQcDate': '2007-02-06', 'lastUpdatePostDateStruct': {'date': '2009-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postural control', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ankle', 'sensorimotor', 'reflex', 'training'], 'conditions': ['Ankle Injury']}, 'descriptionModule': {'briefSummary': 'This study is evaluating reflex board training to see if it will help people who frequently roll their ankles. We are investigating several tests that evaluate the ability of the neuromuscular system to control ankle movement. This study is in 2 parts:Part 1 looks at changes after 1 day of reflex training; Part 2 looks at changes after 6 weeks of reflex training. It is thought that the reflex training will improve measures of static and dynamic balance as well as spinal reflex measures.', 'detailedDescription': 'Research has utilized multiple measures in an effort to detect chronic ankle instability (CAI). Recently, investigations have focused on assessment of sensorimotor function in those who suffer from CAI. These measures have included traditional and functional postural control variables, as well as measures of joint position sense, neuromuscular control and recruitment, and nerve conduction velocity. This study seeks to modulate sensorimotor measures through both short- and long-term reflex training. This information may help to better assess sensorimotor deficits associated with CAI, to focus future research, evaluate rehabilitation protocols and to improve our understanding of this chronic disability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronically unstable ankles with a history of at least 2 ankle sprains in the past year, M/F 18-30, healthy\n\nExclusion Criteria:\n\n* ankle sprain within past 6 months, any chronic lower extremity injury or condition, neurological condition, balance-inner ear or vestibular condition, any other condition that would interfere with testing'}, 'identificationModule': {'nctId': 'NCT00432705', 'briefTitle': 'Changes in Unstable Ankles After Balance Training', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Charlotte'}, 'officialTitle': 'Modulation of Sensorimotor Measures in Chronically Unstable Ankles', 'orgStudyIdInfo': {'id': '05-11-34-CAI-B'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Checking stability of ankle', 'type': 'PROCEDURE', 'otherNames': ['Flexibility study'], 'description': 'Flexing and walking'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'JoEllen M. Sefton, MS, ATC, CMT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNC Charlotte'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Charlotte', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'JoEllen Sefton', 'oldOrganization': 'UNCCharlotte'}}}}