Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-06-24 @ 11:08 PM
Study NCT ID:
NCT04076657
Status:
COMPLETED
Last Update Posted:
2025-06-05
First Post:
2019-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Brock String Therapy Post Concussion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}], 'ancestors': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Care provider will not be aware of group assignment; participant will be aware of receiving treatment'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2019-08-27', 'studyFirstSubmitQcDate': '2019-08-29', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Near point of convergence measurement', 'timeFrame': 'from visit 1 (<48 hours post injury) to visit 2 (7-10 days post injury)', 'description': 'change in convergence measurement from nose in centimeters'}], 'secondaryOutcomes': [{'measure': 'Immediate Post Concussion Assessment and Cognitive Testing (ImPACT', 'timeFrame': 'from visit 1 (<48 hours post injury) to visit 2 (7-10 days post injury)', 'description': 'change in test scores based on normative data percentile (range \\<1-100); for all composite scores, including verbal memory, visual memory, visual motor speed scores, reaction time; better score indicating better performance'}, {'measure': 'concussion recovery duration', 'timeFrame': 'from day of injury until final clinic visit, determined by concussion symptoms resolving and all aspects of testing within normal limits; expected range 7-10 days to up to 6 months post injury', 'description': 'recovery time (i.e., days from injury until return to play)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['brock string', 'sport-concussion', 'concussion therapy', 'receded near point of convergence'], 'conditions': ['Concussion, Brain', 'Near Point Convergence']}, 'referencesModule': {'references': [{'pmid': '40957852', 'type': 'DERIVED', 'citation': 'Trbovich AM, Zynda AJ, Togashi T, Burley C, Mucha A, Collins MW, Kontos AP. Randomized Controlled Trial of Brock String Vision Therapy for Receded Near Point of Convergence Following Concussion. J Neurotrauma. 2025 Oct;42(19-20):1708-1718. doi: 10.1177/08977151251359960. Epub 2025 Sep 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the proposed study is to evaluate the efficacy of Brock String therapy prescribed in the acute stage of concussion recovery can improve clinical outcomes among patients with receded near point of convergence (NPC).\n\nAim 1: Determine if participants receiving the Brock String have more significant improvements in NPC measurements at follow up 7-10 days post injury.\n\nAim 2: Determine if participants receiving the Brock String 1) improve on computerized neurocognitive test scores from initial visit (\\<48 hours post injury) to follow up visit (7-10 days post injury) compared to control participants, and 2) have reduced recovery time (i.e., days from injury until return to play) compared to control participants.', 'detailedDescription': 'Receded near point of convergence (NPC) is a common oculomotor deficit associated with numerous vision diagnoses, including convergence and accommodative insufficiencies, following sport-related concussion (SRC). Researchers have found associations with worse neurocognitive test scores, higher post-concussion symptom burden, and longer recovery among patients with receded NPC relative to concussion patients with normal NPC. Although oculomotor dysfunction may resolve spontaneously or improves with vision therapy exercises in the post-acute phase of recovery, it is unclear if early intervention can improve recovery outcomes. The Brock String is a cost effective and practical vision therapy exercise for congenital convergence insufficiency (CI), and initial research supports effectiveness with SRC patients who have receded NPC in the subacute phase of recovery (e.g., weeks to months post injury). Early vision therapy intervention may be efficacious in improving recovery times and reduce healthcare costs by eliminating later therapies for chronic deficits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Athletes who sustained a concussion during organized sport within past 48 hours\n* ages 12-20\n* at least one NPC measurement \\>10 centimeters at initial clinic evaluation.\n\nExclusion Criteria:\n\n* lack of access to a smart phone to receive text message prompts\n* vestibular disorder\n* seizure disorder\n* history of traumatic brain injury with imaging findings or brain surgery\n* history of 3+ concussions\\\\\n* concussion within the past 6 months\n* history of developmental or intellectual disability\n* history of substance abuse\n* Patients will also be excluded from recruitment if the treating clinician feels the potential participant would be unable to tolerate Brock String therapy due to severe symptoms'}, 'identificationModule': {'nctId': 'NCT04076657', 'briefTitle': 'Efficacy of Brock String Therapy Post Concussion', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Brock String Therapy for Receded Near Point of Convergence Post Concussion', 'orgStudyIdInfo': {'id': 'STUDY19070375'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brock String', 'description': 'Participants will receive instruction on Brock String therapy after first clinic visit (\\<48 hours post) injury, and will complete home therapy exercise twice daily', 'interventionNames': ['Behavioral: Brock String Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Participants will receive standard of care (i.e., no Brock String therapy within the first week post injury) but will be informed they will receive any therapy deemed necessary at follow up visit 7-10 days post injury, consistent with standard of care', 'interventionNames': ['Behavioral: Standard of Care']}], 'interventions': [{'name': 'Brock String Therapy', 'type': 'BEHAVIORAL', 'description': 'Oculomotor exercise to improve binocular vision function', 'armGroupLabels': ['Brock String']}, {'name': 'Standard of Care', 'type': 'BEHAVIORAL', 'description': 'patient engages in normal behavior to manage vision issues, such as breaks with reading and screen use', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15203', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center, Rooney Sports Complex', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Alicia Trbovich, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}, {'name': 'Anthony P Kontos, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Alicia Trbovich', 'investigatorAffiliation': 'University of Pittsburgh'}}}}