Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-01 @ 6:50 PM
Study NCT ID:
NCT03036527
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2017-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Recovery of Bladder and Sexual Function After Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'charles.hubscher@louisville.edu', 'phone': '502-852-3058', 'title': 'Charles Hubscher', 'organization': 'University of Louisville'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '5 years, 2 months', 'eventGroups': [{'id': 'EG000', 'title': 'Activity-based Locomotor Training', 'description': 'To understand the effects of weight-bearing activity-based locomotor therapy on bladder function and sexual function. Activity-based locomotor training interventions include locomotor step training with a harness and body-weight support, 5 days a week for a total of 80, 1-hour sessions.\n\nActivity-based locomotor training: The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stepping (IRB 07.0066).', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Activity-based Stand Training', 'description': 'To understand the effects of weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based stand training interventions include stand training with a harness and body-weight support or stand training over ground, 5 days a week for a total of 80, 1-hour sessions.\n\nActivity-based stand training: The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stand only program (07.0268). The stand only intervention may also be provided as part of this study.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Activity-based Upper Arm Ergometry', 'description': 'To understand the effects of non-weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based upper arm ergometry interventions may include arm crank training (upper arm ergometry) in while seated in the wheelchair 5 days a week for a total of 80, 1-hour sessions.\n\nActivity-based upper arm ergometry: The non-weight bearing activity-based upper arm ergometry intervention will be provided via a standardized arm crank therapy provided within this study.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Activity Based Training + Spinal Epidural Stimulation.', 'description': 'Combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Left Hand Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Bladder Storage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Activity-based Locomotor Training', 'description': 'To understand the effects of weight-bearing activity-based locomotor therapy on bladder function and sexual function. Activity-based locomotor training interventions include locomotor step training with a harness and body-weight support, 5 days a week for a total of 80, 1-hour sessions.\n\nActivity-based locomotor training: The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stepping (IRB 07.0066).'}, {'id': 'OG001', 'title': 'Activity-based Stand Training', 'description': 'To understand the effects of weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based stand training interventions include stand training with a harness and body-weight support or stand training over ground, 5 days a week for a total of 80, 1-hour sessions.\n\nActivity-based stand training: The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stand only program (07.0268). The stand only intervention may also be provided as part of this study.'}, {'id': 'OG002', 'title': 'Activity-based Upper Arm Ergometry', 'description': 'To understand the effects of non-weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based upper arm ergometry interventions may include arm crank training (upper arm ergometry) in while seated in the wheelchair 5 days a week for a total of 80, 1-hour sessions.\n\nActivity-based upper arm ergometry: The non-weight bearing activity-based upper arm ergometry intervention will be provided via a standardized arm crank therapy provided within this study.'}, {'id': 'OG003', 'title': 'Activity-based Training With Spinal Epidural Stimulation', 'description': 'To understand the combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.'}], 'classes': [{'categories': [{'measurements': [{'value': '278.5', 'spread': '147.8', 'groupId': 'OG000'}, {'value': '447.75', 'spread': '278.9', 'groupId': 'OG001'}, {'value': '580.5', 'spread': '313.2', 'groupId': 'OG002'}, {'value': '313.0', 'spread': '166', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years, 2 months', 'description': 'Bladder capacity (mlH2O)', 'unitOfMeasure': 'mLH2O', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Bladder Emptying', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Activity-based Locomotor Training', 'description': 'To understand the effects of weight-bearing activity-based locomotor therapy on bladder function and sexual function. Activity-based locomotor training interventions include locomotor step training with a harness and body-weight support, 5 days a week for a total of 80, 1-hour sessions.\n\nActivity-based locomotor training: The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stepping (IRB 07.0066).'}, {'id': 'OG001', 'title': 'Activity-based Stand Training', 'description': 'To understand the effects of weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based stand training interventions include stand training with a harness and body-weight support or stand training over ground, 5 days a week for a total of 80, 1-hour sessions.\n\nActivity-based stand training: The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stand only program (07.0268). The stand only intervention may also be provided as part of this study.'}, {'id': 'OG002', 'title': 'Activity-based Upper Arm Ergometry', 'description': 'To understand the effects of non-weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based upper arm ergometry interventions may include arm crank training (upper arm ergometry) in while seated in the wheelchair 5 days a week for a total of 80, 1-hour sessions.\n\nActivity-based upper arm ergometry: The non-weight bearing activity-based upper arm ergometry intervention will be provided via a standardized arm crank therapy provided within this study.'}, {'id': 'OG003', 'title': 'Activity-based Training With Spinal Epidural Stimulation', 'description': 'To understand the combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.9', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '13.0', 'groupId': 'OG001'}, {'value': '12.8', 'spread': '19.8', 'groupId': 'OG002'}, {'value': '28.0', 'spread': '33.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years, 2 months', 'description': 'Voiding Efficiency (% voided)', 'unitOfMeasure': '% Void Efficiency', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Bladder Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Activity-based Locomotor Training', 'description': 'To understand the effects of weight-bearing activity-based locomotor therapy on bladder function and sexual function. Activity-based locomotor training interventions include locomotor step training with a harness and body-weight support, 5 days a week for a total of 80, 1-hour sessions.\n\nActivity-based locomotor training: The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stepping (IRB 07.0066).'}, {'id': 'OG001', 'title': 'Activity-based Stand Training', 'description': 'To understand the effects of weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based stand training interventions include stand training with a harness and body-weight support or stand training over ground, 5 days a week for a total of 80, 1-hour sessions.\n\nActivity-based stand training: The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stand only program (07.0268). The stand only intervention may also be provided as part of this study.'}, {'id': 'OG002', 'title': 'Activity-based Upper Arm Ergometry', 'description': 'To understand the effects of non-weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based upper arm ergometry interventions may include arm crank training (upper arm ergometry) in while seated in the wheelchair 5 days a week for a total of 80, 1-hour sessions.\n\nActivity-based upper arm ergometry: The non-weight bearing activity-based upper arm ergometry intervention will be provided via a standardized arm crank therapy provided within this study.'}, {'id': 'OG003', 'title': 'Activity-based Training + Spinal Epidural Stimulation', 'description': 'To understand the combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.7', 'spread': '18.6', 'groupId': 'OG000'}, {'value': '33.75', 'spread': '22.7', 'groupId': 'OG001'}, {'value': '45', 'spread': '36.2', 'groupId': 'OG002'}, {'value': '29.0', 'spread': '20.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years, 2 months', 'description': 'Leak point pressure (cmH2O)', 'unitOfMeasure': 'cm H2O', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Activity-based Locomotor Training', 'description': 'To understand the effects of weight-bearing activity-based locomotor therapy on bladder function and sexual function. Activity-based locomotor training interventions include locomotor step training with a harness and body-weight support, 5 days a week for a total of 80, 1-hour sessions.\n\nActivity-based locomotor training: The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stepping (IRB 07.0066).'}, {'id': 'OG001', 'title': 'Activity-based Stand Training', 'description': 'To understand the effects of weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based stand training interventions include stand training with a harness and body-weight support or stand training over ground, 5 days a week for a total of 80, 1-hour sessions.\n\nActivity-based stand training: The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stand only program (07.0268). The stand only intervention may also be provided as part of this study.'}, {'id': 'OG002', 'title': 'Activity-based Upper Arm Ergometry', 'description': 'To understand the effects of non-weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based upper arm ergometry interventions may include arm crank training (upper arm ergometry) in while seated in the wheelchair 5 days a week for a total of 80, 1-hour sessions.\n\nActivity-based upper arm ergometry: The non-weight bearing activity-based upper arm ergometry intervention will be provided via a standardized arm crank therapy provided within this study.'}, {'id': 'OG003', 'title': 'Activity-based Training + Spinal Epidural Stimulation', 'description': 'To understand the combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.5', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '33.8', 'spread': '12.5', 'groupId': 'OG001'}, {'value': '17.0', 'spread': '5.8', 'groupId': 'OG002'}, {'value': '20.0', 'spread': '25.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years, 2 months', 'description': 'Bladder Compliance (ml/cmH2O)', 'unitOfMeasure': 'mL/cmH2O', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'International Index of Erectile Function (IIEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Activity-based Locomotor Training', 'description': 'To understand the effects of weight-bearing activity-based locomotor therapy on bladder function and sexual function. Activity-based locomotor training interventions include locomotor step training with a harness and body-weight support, 5 days a week for a total of 80, 1-hour sessions.\n\nActivity-based locomotor training: The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stepping (IRB 07.0066).'}, {'id': 'OG001', 'title': 'Activity-based Stand Training', 'description': 'To understand the effects of weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based stand training interventions include stand training with a harness and body-weight support or stand training over ground, 5 days a week for a total of 80, 1-hour sessions.\n\nActivity-based stand training: The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stand only program (07.0268). The stand only intervention may also be provided as part of this study.'}, {'id': 'OG002', 'title': 'Activity-based Upper Arm Ergometry', 'description': 'To understand the effects of non-weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based upper arm ergometry interventions may include arm crank training (upper arm ergometry) in while seated in the wheelchair 5 days a week for a total of 80, 1-hour sessions.\n\nActivity-based upper arm ergometry: The non-weight bearing activity-based upper arm ergometry intervention will be provided via a standardized arm crank therapy provided within this study.'}, {'id': 'OG003', 'title': 'Activity Based Training + Spinal Epidural Stimulation', 'description': 'combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.8', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '26.4', 'spread': '5.7', 'groupId': 'OG001'}, {'value': '30.0', 'spread': '8.8', 'groupId': 'OG002'}, {'value': '29.7', 'spread': '7.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years, 2 months', 'description': 'There are 5 domains to the International Index of Erectile Function questionnaire: erectile function, intercourse satisfaction, orgasmic function, sexual desire, and overall satisfaction.\n\nScoring 1-7: severe erectile dysfunction (ED), 8-11: Moderate ED, 12-16: mild-moderate ED, 17-21 mild ED, 22-25: no ED. Higher values represent better outcomes.\n\nOverall IIEF score range is 5-75; total \\>61.8 considered normal.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Male data only (insufficient N for females)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Activity-based Locomotor Training', 'description': 'To understand the effects of weight-bearing activity-based locomotor therapy on bladder function and sexual function. Activity-based locomotor training interventions include locomotor step training with a harness and body-weight support, 5 days a week for a total of 80, 1-hour sessions.\n\nActivity-based locomotor training: The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stepping (IRB 07.0066).'}, {'id': 'FG001', 'title': 'Activity-based Stand Training', 'description': 'To understand the effects of weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based stand training interventions include stand training with a harness and body-weight support or stand training over ground, 5 days a week for a total of 80, 1-hour sessions.\n\nActivity-based stand training: The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stand only program (07.0268). The stand only intervention may also be provided as part of this study.'}, {'id': 'FG002', 'title': 'Activity-based Upper Arm Ergometry', 'description': 'To understand the effects of non-weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based upper arm ergometry interventions may include arm crank training (upper arm ergometry) in while seated in the wheelchair 5 days a week for a total of 80, 1-hour sessions.\n\nActivity-based upper arm ergometry: The non-weight bearing activity-based upper arm ergometry intervention will be provided via a standardized arm crank therapy provided within this study.'}, {'id': 'FG003', 'title': 'Activity-based Training + Spinal Epidural Stimulation', 'description': 'combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Activity-based Locomotor Training', 'description': 'To understand the effects of weight-bearing activity-based locomotor therapy on bladder function and sexual function. Activity-based locomotor training interventions include locomotor step training with a harness and body-weight support, 5 days a week for a total of 80, 1-hour sessions.\n\nActivity-based locomotor training: The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stepping (IRB 07.0066).'}, {'id': 'BG001', 'title': 'Activity-based Stand Training', 'description': 'To understand the effects of weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based stand training interventions include stand training with a harness and body-weight support or stand training over ground, 5 days a week for a total of 80, 1-hour sessions.\n\nActivity-based stand training: The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stand only program (07.0268). The stand only intervention may also be provided as part of this study.'}, {'id': 'BG002', 'title': 'Activity-based Upper Arm Ergometry', 'description': 'To understand the effects of non-weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based upper arm ergometry interventions may include arm crank training (upper arm ergometry) in while seated in the wheelchair 5 days a week for a total of 80, 1-hour sessions.\n\nActivity-based upper arm ergometry: The non-weight bearing activity-based upper arm ergometry intervention will be provided via a standardized arm crank therapy provided within this study.'}, {'id': 'BG003', 'title': 'Activity-based Training + Spinal Epidural Stimulation', 'description': 'To understand the combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.4', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '39'}, {'value': '33.75', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '50'}, {'value': '31.3', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '62'}, {'value': '28.6', 'groupId': 'BG003', 'lowerLimit': '22', 'upperLimit': '35'}, {'value': '30.8', 'groupId': 'BG004', 'lowerLimit': '19', 'upperLimit': '62'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-09', 'size': 1468964, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-10-08T09:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2019-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-12', 'studyFirstSubmitDate': '2017-01-09', 'resultsFirstSubmitDate': '2021-10-12', 'studyFirstSubmitQcDate': '2017-01-26', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-12', 'studyFirstPostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bladder Storage', 'timeFrame': '5 years, 2 months', 'description': 'Bladder capacity (mlH2O)'}, {'measure': 'Bladder Emptying', 'timeFrame': '5 years, 2 months', 'description': 'Voiding Efficiency (% voided)'}, {'measure': 'Bladder Pressure', 'timeFrame': '5 years, 2 months', 'description': 'Leak point pressure (cmH2O)'}, {'measure': 'Compliance', 'timeFrame': '5 years, 2 months', 'description': 'Bladder Compliance (ml/cmH2O)'}], 'secondaryOutcomes': [{'measure': 'International Index of Erectile Function (IIEF)', 'timeFrame': '5 years, 2 months', 'description': 'There are 5 domains to the International Index of Erectile Function questionnaire: erectile function, intercourse satisfaction, orgasmic function, sexual desire, and overall satisfaction.\n\nScoring 1-7: severe erectile dysfunction (ED), 8-11: Moderate ED, 12-16: mild-moderate ED, 17-21 mild ED, 22-25: no ED. Higher values represent better outcomes.\n\nOverall IIEF score range is 5-75; total \\>61.8 considered normal.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bladder', 'Sexual Function'], 'conditions': ['Spinal Cord Injuries']}, 'referencesModule': {'references': [{'pmid': '33278365', 'type': 'DERIVED', 'citation': 'Hubscher CH, Wyles J, Gallahar A, Johnson K, Willhite A, Harkema SJ, Herrity AN. Effect of Different Forms of Activity-Based Recovery Training on Bladder, Bowel, and Sexual Function After Spinal Cord Injury. Arch Phys Med Rehabil. 2021 May;102(5):865-873. doi: 10.1016/j.apmr.2020.11.002. Epub 2020 Dec 3.'}, {'pmid': '29385166', 'type': 'DERIVED', 'citation': 'Hubscher CH, Herrity AN, Williams CS, Montgomery LR, Willhite AM, Angeli CA, Harkema SJ. Improvements in bladder, bowel and sexual outcomes following task-specific locomotor training in human spinal cord injury. PLoS One. 2018 Jan 31;13(1):e0190998. doi: 10.1371/journal.pone.0190998. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': "Bladder and sexual dysfunction consistently ranks as one of the top disorders affecting quality of life after spinal cord injury. The insights of how activity-based training affects bladder function may prove to be useful to other patient populations with bladder and sexual dysfunction such as multiple sclerosis, Parkinson's, and stroke, as well as stimulate investigations of training's effects within other systems such as bowel dysfunction. Locomotor training could help promote functional recovery and any insights gained from these studies will enhance further investigation of the effect of bladder functioning after spinal cord injury. In addition, as suggested by a study of one of our initial participants, a reduction in the use and/or dosage of medication to enhance sexual function is a possible outcome, medications which carry risks and side effects.", 'detailedDescription': 'Objectives: To determine the effects of weight-bearing task-specific training for locomotion (stepping on a treadmill) after traumatic incomplete and complete spinal cord injury in humans on a) urodynamic parameters and b) sexual function outcomes. Weight-bearing (stand-only) and non-weight-bearing exercise (i.e. arm crank) will serve as controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Criteria: Inclusion Criteria:\n\n* stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate locomotor training, stand, or non-weight bearing training\n* no painful musculoskeletal dysfunction,\n* unhealed fracture, contracture, pressure sore or urinary tract infection that might interfere with training\n* no clinically significant depression or ongoing drug abuse;\n* clear indications that the period of spinal shock is concluded determined by presence of muscle tone, deep tendon reflexes or muscle spasms and discharged from standard inpatient rehabilitation\n* non- progressive suprasacral spinal cord injury\n* bladder and sexual dysfunction as a result of spinal cord injury\n\nExclusion criteria:\n\n* unstable medical condition with cardiopulmonary disease or dysautonomia that would contraindicate locomotor training, stand, or non-weight bearing training;\n* painful musculoskeletal dysfunction, unhealed fractures, contractures, pressure sores or urinary tract infections that might interfere with training\n* clinically significant depression or ongoing drug abuse;\n* clear indications that the period of spinal shock has not concluded and not discharged from standard inpatient rehabilitation\n* progressive spinal cord injury\n* no bladder and sexual dysfunction as a result of spinal cord injury'}, 'identificationModule': {'nctId': 'NCT03036527', 'briefTitle': 'Recovery of Bladder and Sexual Function After Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'Effects of Activity Dependent Plasticity on Recovery of Bladder and Sexual Function After Human Spinal Cord Injury', 'orgStudyIdInfo': {'id': '14.0062 Bladder Sex Fxn'}, 'secondaryIdInfos': [{'id': '5R01HD080205', 'link': 'https://reporter.nih.gov/quickSearch/5R01HD080205', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Activity-based locomotor training', 'description': 'To understand the effects of weight-bearing activity-based locomotor therapy on bladder function and sexual function. Activity-based locomotor training interventions include locomotor step training with a harness and body-weight support, 5 days a week for a total of 80, 1-hour sessions.', 'interventionNames': ['Procedure: Activity-based locomotor training']}, {'type': 'EXPERIMENTAL', 'label': 'Activity-based stand training', 'description': 'To understand the effects of weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based stand training interventions include stand training with a harness and body-weight support or stand training over ground, 5 days a week for a total of 80, 1-hour sessions.', 'interventionNames': ['Procedure: Activity-based stand training']}, {'type': 'EXPERIMENTAL', 'label': 'Activity-based upper arm ergometry', 'description': 'To understand the effects of non-weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based upper arm ergometry interventions may include arm crank training (upper arm ergometry) in while seated in the wheelchair 5 days a week for a total of 80, 1-hour sessions.', 'interventionNames': ['Procedure: Activity-based upper arm ergometry']}, {'type': 'EXPERIMENTAL', 'label': 'Activity based training + spinal epidural stimulation', 'description': 'combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.', 'interventionNames': ['Procedure: Activity-based locomotor training', 'Procedure: Activity-based stand training', 'Procedure: Activity-based training + spinal epidural stimulation']}], 'interventions': [{'name': 'Activity-based locomotor training', 'type': 'PROCEDURE', 'otherNames': ['Locomotor training'], 'description': 'The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stepping (IRB 07.0066).', 'armGroupLabels': ['Activity based training + spinal epidural stimulation', 'Activity-based locomotor training']}, {'name': 'Activity-based stand training', 'type': 'PROCEDURE', 'otherNames': ['Stand training'], 'description': 'The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stand only program (07.0268). The stand only intervention may also be provided as part of this study.', 'armGroupLabels': ['Activity based training + spinal epidural stimulation', 'Activity-based stand training']}, {'name': 'Activity-based upper arm ergometry', 'type': 'PROCEDURE', 'otherNames': ['Arm Crank'], 'description': 'The non-weight bearing activity-based upper arm ergometry intervention will be provided via a standardized arm crank therapy provided within this study.', 'armGroupLabels': ['Activity-based upper arm ergometry']}, {'name': 'Activity-based training + spinal epidural stimulation', 'type': 'PROCEDURE', 'description': 'combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.', 'armGroupLabels': ['Activity based training + spinal epidural stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'Ralph Nitkin, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Institutes of Health (NIH)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Associate Director, Kentucky Spinal Cord Injury Research Center, University of Louisville Owsley B. Frazier Chair in Neurological Rehabilitation Research Director, Frazier Rehab Institute Director of the NeuroRecovery Network', 'investigatorFullName': 'Susan Harkema PhD', 'investigatorAffiliation': 'University of Louisville'}}}}