Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-03-06 @ 1:24 PM
Study NCT ID:
NCT05373992
Status:
COMPLETED
Last Update Posted:
2024-10-18
First Post:
2022-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concussion Screen Use Recovery Time
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': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-16', 'studyFirstSubmitDate': '2022-05-10', 'studyFirstSubmitQcDate': '2022-05-10', 'lastUpdatePostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recovery Time', 'timeFrame': "Day-1 of the participant's self-reported asymptomatic response to unrestricted physical and cognitive activities", 'description': "Primary outcome is recovery time (days) as measured as the number of days between the date of injury and day-1 of the participant's self-reported asymptomatic response to unrestricted physical and cognitive activities, which must occur for at least three consecutive days."}], 'secondaryOutcomes': [{'measure': 'Protracted recovery', 'timeFrame': 'Greater than 30-days', 'description': 'Secondary outcome is protracted recovery. A positive classification for protracted recovery is defined as a recovery time, as specified previously, greater than 30-days.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Concussion', 'Sports related head injury'], 'conditions': ['Sport-related Concussion']}, 'descriptionModule': {'briefSummary': "A two-year parallel randomized clinical trial study to examine the effect of screen time (ST) restriction, exercise alone, and combined ST-restricted-exercise when compared to stretching only (control group) on sports related concussion recovery time among adolescents aged 12 to 17 years. Study hypothesis 1 - There will be significant differences between the treatment and the control arms' mean recovery time (days). Study hypothesis 2 - The ST-restricted \\& exercise treatment arm will have a significantly shorter mean recovery time (days) compared with the other treatment arms and control arm.", 'detailedDescription': "The investigators will randomize a sports related concussion (SRC) treatment protocol (n=313) of Children's Health Andrews Institute for Orthopaedics and Sports Medicine (Andrews) pediatric SRC patients (aged 12-17 years) to one of four treatment groups:1. Screen Time (ST) restricted group, 2.Exercise group, 3.ST restricted \\& exercise group, and Control \\[stretching only\\]) group. The treatments will occur for the first 72-hours following the first clinic appointment. The investigators will monitor treatment adherence and 24-hour movement behaviors over a 72-hour period using the ActiGraph GT9X Link and heart rate monitor; a state-of-the-art research grade wearable device that our research team has expertise in administering and analyzing in field-based studies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female subjects\n* Age 12-17 years of age presenting to the Children's Health Andrews Institute for Orthopaedics and Sports Medicine (Andrews) concussion clinic in Plano, Texas, to be treated for a diagnosed SRC\n* Patients who suffered a sport-related concussion within 72-hours of first clinic visit\n\nExclusion Criteria:\n\n* Patients who suffered a sport-related concussion outside of 72-hours of first clinic visit\n* Is not diagnosed with a SRC\n* Is already taking part in another study that measures their physical activity, sleep, screen-time, or is related to concussion\n* Has a current diagnosis of and treatment with medication for attention deficit/hyperactivity disorder, learning disorder, depression, anxiety, or a history of more than 3 prior concussions (because these factors are associated with delayed recovery\n* Has a co-existing musculoskeletal injury that may impact their ability to be physically active during recovery\n* Has an increased cardiac event risk according to the American College of Sports Medicine criteria\n* Has a symptom severity score of less than 5 points on the post-concussion symptom scale during the initial clinical examination\n* Has an ability to exercise to exhaustion without symptom provocation during the initial clinical examination\n* Has limited English language proficiency"}, 'identificationModule': {'nctId': 'NCT05373992', 'briefTitle': 'Concussion Screen Use Recovery Time', 'organization': {'class': 'OTHER', 'fullName': "Children's Health"}, 'officialTitle': 'Effect of Exercise and Restrictions to Screen-time on Sport-related Concussion Recovery Time Among Adolescents', 'orgStudyIdInfo': {'id': 'STU-2022-0150'}, 'secondaryIdInfos': [{'id': 'ABC', 'type': 'OTHER', 'domain': "Children's Health Foundation"}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Screen Time Restricted', 'description': 'Participants will be asked to limit all screen-based activities (television, smartphone, tablet, computer) for the first 72-hours following the initial clinic visit. After the first 72-hours following the initial clinic visit, participants will follow the standard of care as prescribed by their provider. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.', 'interventionNames': ['Behavioral: Screen Time Restriction (ST-Restricted)']}, {'type': 'EXPERIMENTAL', 'label': 'Aerobic Exercise', 'description': 'Participants will be asked to engage in 30-minutes of aerobic exercise (AE) daily for the first 72-hours following the initial clinic visit in the form of a stationary exercise bike, treadmill, or outdoors. The exercise intensity will be prescribed not to exceed 60% of the age-based maximum heart rate. After the first 72-hours following the initial clinic visit, participants will follow the standard of care as prescribed by their provider. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.', 'interventionNames': ['Behavioral: Aerobic Exercise (AE)']}, {'type': 'EXPERIMENTAL', 'label': 'Screen Time Restricted & Aerobic Exercise', 'description': 'Participants will be asked to limit all screen-based activities (television, smartphone, tablet, computer) as well as engage in 30-minutes of AE in the form of a stationary exercise bike, treadmill, or outdoors, for the first 72-hours following the initial clinic visit. The exercise intensity will be prescribed not to exceed 60% of the age-based maximum heart rate. After the first 72-hours following the initial clinic visit, participants will follow the standard of care as prescribed by their provider. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.', 'interventionNames': ['Behavioral: Screen-time restricted plus aerobic exercise (STR+AE)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stretching', 'description': 'Participants will be asked to follow a daily stretching program for the first 72-hours following the initial clinic visit. After the first 72-hours following the initial clinic visit, participants will follow the standard of care as prescribed by their provider. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.', 'interventionNames': ['Behavioral: Stretching Only']}], 'interventions': [{'name': 'Screen Time Restriction (ST-Restricted)', 'type': 'BEHAVIORAL', 'description': 'Participants will be asked to limit all screen-based activities (television, smartphone, tablet, computer) for the first 72-hours following the initial clinic visit. Following the first 72-hours of restricted screen-time, participants will follow the standard of care until the second clinic visit at 7-days post the first clinic visit. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.', 'armGroupLabels': ['Screen Time Restricted']}, {'name': 'Aerobic Exercise (AE)', 'type': 'BEHAVIORAL', 'description': 'Engage in 30-minutes of aerobic exercise daily for the first 72-hours following the initial clinic visit in the form of a stationary exercise bike, treadmill, or outdoors. The exercise intensity will be prescribed not to exceed 60% of the age-based maximum heart rate (HR). Following the first 72-hours of prescribed AE, participants will follow the standard of care until the second clinic visit at 7-days post the first clinic visit. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.', 'armGroupLabels': ['Aerobic Exercise']}, {'name': 'Screen-time restricted plus aerobic exercise (STR+AE)', 'type': 'BEHAVIORAL', 'description': 'Participants will be asked to limit all screen-based activities (television, smartphone, tablet, computer) while concurrently engaging in daily aerobic exercise in the form of a stationary exercise bike, treadmill, or outdoors, for the first 72-hours following the initial clinic visit. The exercise intensity will be prescribed not to exceed 60% of the age-based maximum heart rate (HR). Following the first 72-hours of prescribed STR+AE, participants will follow the standard of care until the second clinic visit at 7-days post the first clinic visit. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.', 'armGroupLabels': ['Screen Time Restricted & Aerobic Exercise']}, {'name': 'Stretching Only', 'type': 'BEHAVIORAL', 'description': 'Participants will be instructed to follow a prescribed stretching program for the first 72-hours following the initial clinic visit. Following the first 72-hours of prescribed stretching, participants will follow the standard of care until the second clinic visit at 7-days post the first clinic visit. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.', 'armGroupLabels': ['Stretching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75024', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Health - Andrews Institute", 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Health", 'class': 'OTHER'}, 'collaborators': [{'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Andrews Institute Research', 'investigatorFullName': 'John Abt, PhD', 'investigatorAffiliation': "Children's Health"}}}}