Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-03-25 @ 3:35 AM
Study NCT ID:
NCT02389504
Status:
WITHDRAWN
Last Update Posted:
2019-01-16
First Post:
2015-02-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Investigation of Return to Play Exertion Protocol in Concussed Adolescents
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Primary study team member left organization, study was not completed.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-01-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-14', 'studyFirstSubmitDate': '2015-02-26', 'studyFirstSubmitQcDate': '2015-03-10', 'lastUpdatePostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of the current standard of care exertion protocol versus a newly developed program that emphasizes dynamic movement and sport-specific activities as measured by patient symtom scales and neurocognitive testing performance', 'timeFrame': '4 weeks', 'description': 'To empirically assess the efficacy of the current standard of care as it relates to a gradual increase in physical activity relative to a newly developed program. The current standard of care focuses on heart rate and duration of physical activity where all athletes are progressed in the same fashion based on ability to tolerate symptoms while running on a treadmill; by contrast, the newly developed program emphasizes dynamic movement (incorporating lateral movement and planar changes in addition to treadmill running) that more closely approximate movements made while playing sports where rehabilitation is based on specific symptom deficits.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Exertion', 'Efficacy of Treatment'], 'conditions': ['Concussion']}, 'descriptionModule': {'briefSummary': 'An Investigation of Return to Play Exertion Protocol in Concussed Adolescents', 'detailedDescription': 'Written informed parental consent and assent will be obtained for all subjects. The PI or Co-I will administer ImPACT (Immediate Post-Concussion Assessment and Cognitive Testing), the PCSS (Post Concussion Symptom Scale), and the VOMS (Vestibular Ocular Motor Screening) to each subject during their first clinical visit. In addition to demographic variables such as age and gender, groups will be matched based on ImPACT and VOMS performance as well as the number, type, and severity of symptoms reported on the PCSS. Subjects will be assigned to receive either the currently accepted standard of care (Heart Rate Exertion group) or the newly developed exertion protocol (Dynamic Exertion Group). Participants will be matched according to PCSS total, VOMS symptom report, and by demographic variables including age and gender. The first participant will be assigned to the dynamic exertion group and the next to the standard of care group, alternating accordingly as covariates allow. The physical therapists will be responsible for administering the assigned exertion protocol to each subject across four time points (one week between each session). Follow-up data regarding recovery time (i.e., clinical return to normal activity) will also be collected. Neurocognitive testing will take place on 3-4 week intervals as is consistent with clinical practice. The current study will include a pre-exertion neurocognitive evaluation and a post-exertion protocol neurocognitive evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 14-17 years of age\n* Referred to exertion physical therapy within 6 weeks of sport related concussion\n\nExclusion Criteria:\n\n* Family history of mood or anxiety disorder\n* Diagnosis or treatment of migraine\n* Diagnosed history of learning disability, ADHD (Attention Deficit Hyperactivity Disorder)\n* Concussion history of 3 or more\n* Other factors that would prevent subject from completing exertion protocol'}, 'identificationModule': {'nctId': 'NCT02389504', 'briefTitle': 'An Investigation of Return to Play Exertion Protocol in Concussed Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'An Investigation of Return to Play Exertion Protocol in Concussed Adolescents', 'orgStudyIdInfo': {'id': 'PRO14070006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Physical Therapy Protocol', 'description': 'Regular Physical Therapy Protocol. Standard treadmill running, monitoring heart rate', 'interventionNames': ['Other: Standard Exertional Physical Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Exertion Physical Therapy Protocol', 'description': 'Exertional Physical Therapy Protocol. Dynamic exertion protocol includes the treadmill running aspect, but also incorporates other exercises that involve lateral movement (e.g., side lunges, lateral speed training exercises) as well as planar changes (e.g., burpees, squat thrusts) . Recovery on these exercises is measured based on time subjects are able to tolerate the exertion without symptom increase. Across all exertion protocols additional measures of subjective physical effort and objective measurement of heart rate are taken.', 'interventionNames': ['Other: Dynamic Exertional Physical Therapy']}], 'interventions': [{'name': 'Dynamic Exertional Physical Therapy', 'type': 'OTHER', 'description': 'By contrast, the dynamic exertion protocol includes the treadmill running aspect, but also incorporates other exercises that involve lateral movement (e.g., side lunges, lateral speed training exercises) as well as planar changes (e.g., burpees, squat thrusts) . Recovery on these exercises is measured based on time subjects are able to tolerate the exertion without symptom increase. Across all exertion protocols additional measures of subjective physical effort and objective measurement of heart rate are taken.', 'armGroupLabels': ['Exertion Physical Therapy Protocol']}, {'name': 'Standard Exertional Physical Therapy', 'type': 'OTHER', 'description': 'Standard treadmill running, monitoring heart rate', 'armGroupLabels': ['Standard Physical Therapy Protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15203', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UMPC Sports Medicine Concussion Research Program', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Director', 'investigatorFullName': 'Anthony P. Kontos, Ph.D.', 'investigatorAffiliation': 'University of Pittsburgh'}}}}