Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-01-06 @ 3:19 PM
Study NCT ID:
NCT03478059
Status:
COMPLETED
Last Update Posted:
2019-08-30
First Post:
2018-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-29', 'studyFirstSubmitDate': '2018-03-20', 'studyFirstSubmitQcDate': '2018-03-20', 'lastUpdatePostDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in peak velocity turns during Instrumented Stand and Walk Test', 'timeFrame': 'At baseline and after 6 weeks of intervention', 'description': 'Change in peak velocity during 180 degree turns during Instrumented Stand and Walk Test in single task (ST) and dual-task (DT) conditions. DT condition involves grid memorization task.'}], 'secondaryOutcomes': [{'measure': 'Change in peak turning velocity during walking a custom turning course', 'timeFrame': 'At baseline and after 6 weeks of intervention', 'description': 'Change in peak turning velocity during walking a custom turning course in ST and DT conditions.'}, {'measure': 'Change in peak turning velocity during running an agility course', 'timeFrame': 'At baseline and after 6 weeks of intervention', 'description': 'Change in peak turning velocity during running an agility course in ST and DT conditions.'}, {'measure': 'Change in medial -lateral (coronal plane) sway area during eyes closed, narrowed stance', 'timeFrame': 'At baseline and after 6 weeks of intervention', 'description': 'Change in medial -lateral (coronal plane) sway area during eyes closed, narrowed stance in ST and DT conditions.'}, {'measure': 'Change in Beck Depression Inventory-II', 'timeFrame': 'At baseline and after 6 weeks of intervention', 'description': 'Change in Beck Depression Inventory-II: 21 item self-administered questionnaire that measures intensity of depression.'}, {'measure': 'Change in Beck Anxiety Inventory', 'timeFrame': 'At baseline and after 6 weeks of intervention', 'description': 'Change in Beck Anxiety Inventory: 21 item self-administered questionnaire measuring subjective, somatic, or panic-related symptoms of anxiety.'}, {'measure': 'Change in Patient-specific Functional Scale', 'timeFrame': 'At baseline and after 6 weeks of intervention', 'description': 'Change in Patient-specific Functional Scale -quantifies the amount of functional limitation secondary to symptoms in up to 3 activities that are relevant to the individual patient. 0 to 10 scale, where 0 = unable to perform activity and 10 = able to perform activity at same level as before injury or problem.'}, {'measure': 'Change in Neurobehavioral Symptom Inventory (NSI)', 'timeFrame': 'At baseline and after 6 weeks of intervention', 'description': 'Change in Neurobehavioral Symptom Inventory (NSI): Self-report of residual symptoms "in last 2 weeks", a measure of post-TBI symptom severity, 0-4 scale on 22 symptom questions.'}, {'measure': 'Rey Auditory Verbal Learning Test Score', 'timeFrame': 'At baseline', 'description': 'Rey Auditory Verbal Learning Test which measures verbal learning and memory (short-term)'}, {'measure': 'Comprehensive Trails Making Test Score', 'timeFrame': 'Baseline', 'description': 'Comprehensive Trails Making Test which measures set shifting, attention, psychomotor speed'}, {'measure': 'Verbal Fluency Test Score', 'timeFrame': 'Baseline', 'description': 'Verbal Fluency which tests verbal ability and executive control'}, {'measure': 'NAB Digits Forward/Digits Backward Test Score', 'timeFrame': 'Baseline', 'description': 'NAB Digits Forward/Digits Backward Test which measures attentional capacity and auditory working memory'}, {'measure': 'Stroop Color-Word Test Score', 'timeFrame': 'Baseline', 'description': 'Stroop Color-Word Test to evaluate sustained and selective attention as well as freedom from distractibility and inhibitory control.'}, {'measure': 'Wide Range Achievement Test-4 Reading Score', 'timeFrame': 'Baseline', 'description': 'Wide Range Achievement Test-4 Reading will be used as an estimate of premorbid intellect'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Injury Traumatic Mild', 'Concussion, Brain']}, 'descriptionModule': {'briefSummary': 'This research aims to develop an intervention that combines mTBI-specific motor and cognitive challenges into a progressive and challenging rehabilitation program. We plan to develop and refine a combined motor and cognitive intervention using healthy athletic young adults (n=12) and people with a positive history of non-resolving mTBI (n=12). We will conduct limited feasibility testing by conducting 6 week training sessions with each subject group. We also plan to identify best measures for determining readiness for duty or full function by incorporating and testing 3 dual-task assessment measures using state-of-the-art wearable sensors to quantify movement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria-healthy control:\n\n* Adults aged 18-34 years of age.\n* Strong history of athletic participation including high school and collegiate varsity and/or club sports\n* Current sport or recreational sport participation at least 3 days per week\n* Willingness to participate in 3 times a week 60 minute exercise program conducted at Courage Kenny Research Center (CKRC).\n\nExclusion Criteria-healthy control:\n\n* History of concussion.\n* History of orthopedic or neurologic diagnosis (stroke, multiple sclerosis, Parkinson's Disease, etc.) interfering with subject's ability to exercise\n* Unwilling to exercise.\n* At risk for cardiopulmonary disease as defined by the American College of Sports Medicine.\n* Active medical contraindications by self-report after explanation of dual-task exercise program.\n* Active chemical dependency or major psychiatric disorders (ie., schizophrenia, major psychosis) by self-report.\n\nInclusion criteria-subjects with mTBI residual symptoms:\n\n* Adults aged 18-50 years of age.\n* Self-report of some consistent exercise or activity a minimum of 2-3 days per week.\n* 3 weeks to 24 months post most recent concussion seeking treatment at Courage Kenny Rehabilitation Institute (CKRI) clinics\n* Willingness to participate in 3 times a week 60 minute exercise program conducted at CKRC.\n\nExclusion Criteria- subjects with mTBI residual symptoms:\n\n* History of orthopedic or neurologic diagnosis (stroke, multiple sclerosis, Parkinson Disease, etc.) interfering with subject's ability to exercise\n* Unwilling to exercise.\n* At risk for cardiopulmonary disease as defined by the American College of Sports Medicine.\n* Active medical contraindications by self-report after explanation of dual-task exercise program,\n* Active chemical dependency or major psychiatric disorders (ie., schizophrenia, major psychosis)."}, 'identificationModule': {'nctId': 'NCT03478059', 'briefTitle': 'Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI', 'organization': {'class': 'OTHER', 'fullName': 'Allina Health System'}, 'officialTitle': 'Exploring the Role of Combined Cognitive and Motor Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI', 'orgStudyIdInfo': {'id': 'CKMW-1701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mild Traumatic Brain Injury', 'description': '60 minute, 3 times per week, 6 week long Cognitive and Motor Dual-task Intervention program. The intervention will consist of 6 stations that target known motor and cognitive impairments after mTBI.\n\nSubjects with mTBI residuals will be gently progressed through exercise stations in an individually tailored fashion.', 'interventionNames': ['Behavioral: Cognitive and Motor Dual-task Intervention']}, {'type': 'OTHER', 'label': 'Healthy Control', 'description': '60 minute, 3 times per week, 6 week long Cognitive and Motor Dual-task Intervention program. The intervention will consist of 6 stations that target known motor and cognitive impairments after mTBI.\n\nIn addition to providing comparison data, the healthy control, athletic 18-34 year old subjects will be used to identify levels and intensity of progressions of dual-task training stations appropriate for highly trained athletes and military personnel recovering from concussion.', 'interventionNames': ['Behavioral: Cognitive and Motor Dual-task Intervention']}], 'interventions': [{'name': 'Cognitive and Motor Dual-task Intervention', 'type': 'BEHAVIORAL', 'description': 'The intervention will take place 3 times per week for 6 weeks (60 minutes/session) and employs motor and cognitive challenges. It is based on known motor and cognitive deficits after mTBI and is structured using a theoretical framework published in another domain of neurologic disease. The intervention will consist of 6 stations that target known motor and cognitive impairments after mTBI. Each station will have 3 levels of difficulty with optional cognitive progressions. Subjects will spend 8 minutes at each station with a 2 minute transition/rest period between stations and will be progressed in motor and cognitive difficulty as able.', 'armGroupLabels': ['Healthy Control', 'Mild Traumatic Brain Injury']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Abbott Northwestern Hospital', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Margaret M Weightman, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Allina Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allina Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Scientific Advisor', 'investigatorFullName': 'Margaret Weightman', 'investigatorAffiliation': 'Allina Health System'}}}}