Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-04-17 @ 12:22 AM
Study NCT ID:
NCT02025569
Status:
TERMINATED
Last Update Posted:
2014-01-01
First Post:
2013-12-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Strain-counterstrain on Ankle Instability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013180', 'term': 'Sprains and Strains'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'whyStopped': 'Data collection was terminated due to unavailability of additional participants.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-30', 'studyFirstSubmitDate': '2013-12-24', 'studyFirstSubmitQcDate': '2013-12-30', 'lastUpdatePostDateStruct': {'date': '2014-01-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Star Excursion Balance Test', 'timeFrame': 'baseline', 'description': 'A measure assessing dynamic standing balance as the individual stands on one leg and reaches, with the other leg, in eight different directions. The distances reached with the non-stance leg are measured.'}, {'measure': 'Star Excursion Balance Test', 'timeFrame': '4 weeks', 'description': 'A measure assessing dynamic standing balance as the individual stands on one leg and reaches, with the other leg, in eight different directions. The distances reached with the non-stance leg are measured.'}], 'secondaryOutcomes': [{'measure': 'Foot and Ankle Ability Measure', 'timeFrame': 'baseline', 'description': 'This measures assesses ankle function skills subjectively via a questionnaire'}, {'measure': 'Foot and Ankle Ability Measure', 'timeFrame': '4 weeks', 'description': 'This measures assesses ankle function skills subjectively via a questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic ankle instability', 'lateral ankle sprain', 'manual therapy', 'star excursion balance test', 'strain and counterstrain'], 'conditions': ['Other Instability, Ankle and Foot']}, 'descriptionModule': {'briefSummary': 'This study seeks to determine the effectiveness of Strain Counterstrain in the treatment of chronic ankle instability.', 'detailedDescription': 'This study aimed to determine the effect of Strain Counterstrain (SCS) on dynamic balance and subjective sense of instability in individuals with chronic ankle instability (CAI). Although many studies have been published on CAI, the cause for this common clinical dysfunction remains inconclusive. No studies have assessed the effectiveness of SCS on CAI. Baseline information on all participants includes a demographic questionnaire, the Star Excursion Balance Test (SEBT), and the Foot and Ankle Ability Measure (FAAM). Participants were randomized into the SCS intervention group or the sham SCS control group. All participants received an intervention (as assigned) once a week for four weeks in addition to performing a prescribed home exercise program. At week four all participants repeated the outcome measures and completed a Global Rating of Change (GROC) form. The primary aim was examined with a 2-way analysis of variance (ANOVA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* history of at least 1 ankle sprain, with pain and/or limping for more than 1 day, at least 3 months earlier\n* 3 of more episodes of ankle giving way in the last 12 months\n* chronic instability attributed to the original sprain injury\n* age between 18-55\n\nExclusion Criteria:\n\n* history of fracture or surgery in the affected ankle\n* any other lower extremity musculoskeletal injury on the side of the involved ankle\n* vestibular dysfunction or disorder\n* history of balance dysfunction\n* history of stroke or any other neurological pathology or disease\n* history of ACL injury\n* current participation in physical therapy or rehabilitation for the ankle injury\n* evidence of CNS dysfunction'}, 'identificationModule': {'nctId': 'NCT02025569', 'briefTitle': 'The Effect of Strain-counterstrain on Ankle Instability', 'organization': {'class': 'OTHER', 'fullName': 'Long Island University'}, 'officialTitle': 'The Effectiveness of Strain Counterstrain in the Treatment of Patients With Chronic Ankle Instability: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'CKCollins-SCS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Strain counterstrain intervention', 'interventionNames': ['Other: Strain Counterstrain']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control Group', 'description': 'Sham Strain Counterstrain intervention', 'interventionNames': ['Other: Sham strain counterstrain']}], 'interventions': [{'name': 'Strain Counterstrain', 'type': 'OTHER', 'armGroupLabels': ['Experimental group']}, {'name': 'Sham strain counterstrain', 'type': 'OTHER', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11201', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island University', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}], 'overallOfficials': [{'name': 'Cristiana K Collins, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Long Island University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Long Island University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Cristiana Kahl Collins, PT, PhD', 'investigatorAffiliation': 'Long Island University'}}}}