Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-04-02 @ 8:03 AM
Study NCT ID:
NCT03670004
Status:
COMPLETED
Last Update Posted:
2022-11-07
First Post:
2018-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Falls in Older Persons With Limb Loss
Sponsor:
Organization:
Raw JSON
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'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Non-Impaired', 'description': 'Able-bodied controls', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Head Injury', 'notes': 'Head injury experienced from a fall during 12-month prospective fall data collection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Serious'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Foot's Height During the Swing Phase of Walking (i.e., Foot Clearance) Measured in Centimeter", 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'units': 'Limbs', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unilateral Below Knee Amputation', 'description': 'Individuals who walk with a below knee prosthesis'}, {'id': 'OG001', 'title': 'Non-Impaired', 'description': 'Able-bodied controls'}], 'classes': [{'title': 'Non-dominant/Impaired, normal speed', 'categories': [{'measurements': [{'value': '6.1', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Dominant/Sound, normal speed', 'categories': [{'measurements': [{'value': '6.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Non-dominant/Impaired, fast speed', 'categories': [{'measurements': [{'value': '5.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Dominant/Sound, fast speed', 'categories': [{'measurements': [{'value': '4.7', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'Foot clearance of self-selected normal and fast speed walking, calculated as the distance (cm) between the toe and ground as measured with an optical motion capture system.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Limbs', 'denomUnitsSelected': 'Limbs', 'populationDescription': 'Foot clearance was measured for each limb at each walking speed'}, {'type': 'PRIMARY', 'title': 'Center of Pressure Sway Area During Eyes Open or Closed as Measured Through a Force Plate During Standing and Calculated as Centimeters Squared', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'units': 'limbs', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unilateral Below Knee Amputation', 'description': 'Individuals who walk with a below knee prosthesis'}, {'id': 'OG001', 'title': 'Non-Impaired', 'description': 'Able-bodied controls'}], 'classes': [{'title': 'Dominant/Sound, eyes open', 'categories': [{'measurements': [{'value': '1.26', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '1.39', 'groupId': 'OG001'}]}]}, {'title': 'Non-dominant/Impaired, eyes open', 'categories': [{'measurements': [{'value': '0.66', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Dominant/Sound, eyes closed', 'categories': [{'measurements': [{'value': '1.22', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Non-dominant/Impaired, eyes closed', 'categories': [{'measurements': [{'value': '0.64', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '0.76', 'spread': '0.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'Center of pressure sway area during eyes open or closed, calculated as the area (cm\\*cm) covered by the center of pressure position during standing as measured with a force plate.', 'unitOfMeasure': 'cm*cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'limbs', 'denomUnitsSelected': 'limbs', 'populationDescription': 'Sway area was measured for each limb for each vision condition of eyes open or closed'}, {'type': 'PRIMARY', 'title': 'Gait Muscle Activation Effort as Measured by Sensors and Integrating Measured Voltage With Respect to Time as to be Calculated as Millivolts Times Seconds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'units': 'Muscle group', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unilateral Below Knee Amputation', 'description': 'Individuals who walk with a below knee prosthesis'}, {'id': 'OG001', 'title': 'Non-Impaired', 'description': 'Able-bodied controls'}], 'classes': [{'title': 'Dominant/Sound Tibilias Anterior, normal speed', 'categories': [{'measurements': [{'value': '0.278', 'spread': '0.069', 'groupId': 'OG000'}, {'value': '0.306', 'spread': '0.067', 'groupId': 'OG001'}]}]}, {'title': 'Dominant/Sound Tibilias Anterior, fast speed', 'categories': [{'measurements': [{'value': '0.372', 'spread': '0.096', 'groupId': 'OG000'}, {'value': '0.348', 'spread': '0.098', 'groupId': 'OG001'}]}]}, {'title': 'Dominant/Sound Gastroc, normal speed', 'categories': [{'measurements': [{'value': '0.360', 'spread': '0.041', 'groupId': 'OG000'}, {'value': '0.256', 'spread': '0.079', 'groupId': 'OG001'}]}]}, {'title': 'Dominant/Sound Gastroc, fast speed', 'categories': [{'measurements': [{'value': '0.307', 'spread': '0.063', 'groupId': 'OG000'}, {'value': '0.318', 'spread': '0.123', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'Integrated Electromyography patterns of leg muscles during self-selected normal and fast speed walking as a proxy measure of muscle effort, calculated from integrating the muscle activity measured by sensors as voltage over time (mv\\*sec)', 'unitOfMeasure': 'mv*sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Muscle group', 'denomUnitsSelected': 'Muscle group', 'populationDescription': 'Integrated EMG was measured for each muscle group of interest at each walking speed'}, {'type': 'SECONDARY', 'title': 'Falls', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unilateral Below Knee Amputation', 'description': 'Individuals who walk with a below knee prosthesis'}, {'id': 'OG001', 'title': 'Non-Impaired', 'description': 'Able-bodied controls'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Number of falls during 12 months prospectively', 'unitOfMeasure': 'Falls', 'reportingStatus': 'POSTED', 'populationDescription': 'Total number of falls 12 months prospectively'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Unilateral Below Knee Amputation', 'description': 'Individuals who walk with a below knee prosthesis'}, {'id': 'FG001', 'title': 'Non-Impaired', 'description': 'Able-bodied controls'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Unilateral Below Knee Amputation', 'description': 'Individuals who walk with a below knee prosthesis'}, {'id': 'BG001', 'title': 'Non-Impaired', 'description': 'Able-bodied controls'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.1', 'spread': '3.8', 'groupId': 'BG000'}, {'value': '71.7', 'spread': '4.2', 'groupId': 'BG001'}, {'value': '71.4', 'spread': '3.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-01', 'size': 231372, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-03T18:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-06', 'studyFirstSubmitDate': '2018-09-11', 'resultsFirstSubmitDate': '2021-11-16', 'studyFirstSubmitQcDate': '2018-09-11', 'lastUpdatePostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-06', 'studyFirstPostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Foot's Height During the Swing Phase of Walking (i.e., Foot Clearance) Measured in Centimeter", 'timeFrame': '1 month', 'description': 'Foot clearance of self-selected normal and fast speed walking, calculated as the distance (cm) between the toe and ground as measured with an optical motion capture system.'}, {'measure': 'Center of Pressure Sway Area During Eyes Open or Closed as Measured Through a Force Plate During Standing and Calculated as Centimeters Squared', 'timeFrame': '1 month', 'description': 'Center of pressure sway area during eyes open or closed, calculated as the area (cm\\*cm) covered by the center of pressure position during standing as measured with a force plate.'}, {'measure': 'Gait Muscle Activation Effort as Measured by Sensors and Integrating Measured Voltage With Respect to Time as to be Calculated as Millivolts Times Seconds', 'timeFrame': '1 month', 'description': 'Integrated Electromyography patterns of leg muscles during self-selected normal and fast speed walking as a proxy measure of muscle effort, calculated from integrating the muscle activity measured by sensors as voltage over time (mv\\*sec)'}], 'secondaryOutcomes': [{'measure': 'Falls', 'timeFrame': '1 year', 'description': 'Number of falls during 12 months prospectively'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Artificial Limbs', 'Amputation', 'Accidental Falls', 'Stability', 'Balance', 'Gait', 'Electromyography'], 'conditions': ['Amputation', 'Elderly']}, 'descriptionModule': {'briefSummary': 'Lower limb prosthesis users are known to be at a substantially increased fall risk compared to able-bodied individuals. The interaction between increased fall risk, reduced balance confidence and high prevalence of a fear of falling often leads to restricted mobility and loss of independence. Critically, the cause of these falls and the role that inherent balance plays in fall risk is poorly understood. This study proposes to identify key differences in balance and mobility between older below-knee prosthesis users and able-bodied individuals. By further understanding the differences between these groups and relationships between fall risk and various outcome measures, intervention techniques can be developed to improve functional balance. An improvement in upright balance will reduce the occurrence of falls and fall related injuries in this veteran population, as well as increase their participation in daily activities and improve their quality of life.', 'detailedDescription': 'Previous studies have shown that persons with transtibial amputations (TTA) are at a substantially increased risk of falling as compared to able-bodied age-matched controls and have reduced confidence in their balance, both contributing to their restricted mobility and daily activity. This risk increases with progressing age, as aging affects musculoskeletal and somatosensory systems that are vital to controlling upright balance (i.e., maintaining the body center-of-mass (BCoM) within the limits of the base-of-support) and are already compromised in persons with TTA. An important consequence of elevated fall incidence is an increased risk of fall-related injuries that may lead to lost participation and independence. The effects of reduced sensory-motor function on upright balance in older adults has been extensively studied and led to development of effective assessment tools and intervention strategies to minimize fall risk. However, the dearth of similar studies and relatively poor understanding of the effects of additional complications from TTA on upright balance have significantly hampered progress towards addressing this important concern for Veterans with TTA. Consequently, this limits knowledge of predictive factors of falls among these prosthesis users and for informing therapeutic interventions that enhance functional balance. Therefore, the primary objective of this research is to develop an improved understanding of the sensory-motor mechanisms underlying upright balance and fall risk in older Veterans with TTA. The proposed study will compare differences between two age- and gender-matched groups: 1) older unilateral prosthesis users and 2) able-bodied controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Older ambulatory individuals with or without unilateral below-knee amputation', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria for the recruitment of subjects with below knee amputation include:\n\n* Transtibial amputation\n* Daily use of their clinically-prescribed prosthesis for ambulation without an assistive device\n* Classified as Medicare Functional Classification Level K2- defined as a patient who "has the ability or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces - a typical community ambulator"\n* Experience walking with a prosthesis for at least one year\n* Residuum and amputated side in good condition (e.g., no adherent scars, lesions, ulcers, infections)\n* Normal or corrected vision\n* Able to walk a 10 m distance and stand quietly for 40 seconds without undue fatigue or health risk\n\nInclusion criteria for the recruitment of able-bodied controls include:\n\n* Normal or corrected vision\n* Able to walk a 10 m distance and stand quietly for 40 seconds without undue fatigue or health risk\n* Suffered one or no falls in the previous 12 months\n\nExclusion Criteria:\n\nExclusion criteria for all recruited subjects (i.e., limb loss and control) include:\n\n* Musculoskeletal (apart from amputation in the case of amputee subjects) and/or vestibular pathologies that would affect balance and/or stability\n* Currently on medication that might affect proprioception and/or balance (e.g., drugs that are ototoxic, such as certain Aminoglycosides and pain killers)\n* Cognitive deficits that preclude understanding of the instructions required to conduct the test'}, 'identificationModule': {'nctId': 'NCT03670004', 'acronym': 'FOPLL', 'briefTitle': 'Falls in Older Persons With Limb Loss', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Sensory-Motor Mechanisms Underlying Fall Risk in Transtibial Amputees', 'orgStudyIdInfo': {'id': 'C1322-W'}, 'secondaryIdInfos': [{'id': 'IK2RX001322', 'link': 'https://reporter.nih.gov/quickSearch/IK2RX001322', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Unilateral Below Knee Amputation', 'description': 'Individuals who walk with a below knee prosthesis'}, {'label': 'Non-Impaired', 'description': 'Able-bodied controls'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Jesse Brown VA Medical Center, Chicago, IL', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Matthew J. Major, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jesse Brown VA Medical Center, Chicago, IL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}