Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-07 @ 6:26 AM
Study NCT ID:
NCT00645567
Status:
COMPLETED
Last Update Posted:
2017-04-07
First Post:
2008-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Biomechanics of Wheelchair Transfers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D010146', 'term': 'Pain'}], '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'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'john.lloyd2@va.gov', 'phone': '813-624-8986', 'title': 'John Lloyd', 'organization': 'James A Haley VA, Tampa'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'PI has left facility. This study did not yield usable results due to staffing, contracting issues. Although 10 individuals signed ICs, 4 actually actively participated in the study and verifiable data is not available for any of the participants.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': 'persons with SCI', 'otherNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hand injury', 'notes': 'UNRELATED hand injury to the subject while he was at his home', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Shoulder Force', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': "Glide n' Go", 'description': 'As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study, but verifiable data is not available for any of the participants.'}, {'id': 'OG001', 'title': 'Standard Transfer Board', 'description': 'As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study, but verifiable data is not available for any of the participants.'}, {'id': 'OG002', 'title': 'Easy Reach Lift', 'description': 'As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study but verifiable data is not available for any of the participants.'}, {'id': 'OG003', 'title': 'Ryno Lift', 'description': 'As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study but verifiable data is not available for any of the participants.'}, {'id': 'OG004', 'title': 'Unassisted Manual Transfer', 'description': 'As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study but verifiable data is not available for any of the participants.'}], 'timeFrame': 'None reported - verifiable data is not available for any of the participants', 'description': 'measurement of applied shoulder force during wheelchair transfers', 'reportingStatus': 'POSTED', 'populationDescription': 'As of the November 2012 update to the IRB, there were no findings at that point. At this time, verifiable data is not available for any of the participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Wheelchair Transfer Interventions', 'description': '5 persons with SCI were recruited and provided informed consent. Four completed the protocol. One was dropped due to an unrelated injury to the subjects hand at his home.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'One individual provided consent \\& was dropped due to an unrelated injury to his hand at his home.', 'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Although 10 individuals signed ICs, 4 actually actively participated in the study as one was dropped due to an unrelated injury.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Wheelchair Transfer Interventions', 'description': 'Persons with SCI who evaluated wheelchair transfer interventions'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.8', 'spread': '11.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'One individual was enrolled in the study but withdrew due to an adverse event (hand injury UNRELATED to the study).'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-05', 'studyFirstSubmitDate': '2008-03-19', 'resultsFirstSubmitDate': '2015-02-27', 'studyFirstSubmitQcDate': '2008-03-19', 'lastUpdatePostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-05', 'studyFirstPostDateStruct': {'date': '2008-03-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shoulder Force', 'timeFrame': 'None reported - verifiable data is not available for any of the participants', 'description': 'measurement of applied shoulder force during wheelchair transfers'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Biomechanics', 'Ergonomics', 'Spinal Cord Injury', 'Pain', 'Shoulder'], 'conditions': ['Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': 'This is a laboratory-based study to evaluate the risk of shoulder injury associated with transfers between wheelchair and vehicle in persons with spinal cord injury. Four new devices will be compared against an unassisted transfer.', 'detailedDescription': "Specific Aims:\n\nThe purpose of this 3 year laboratory-based randomized crossover study is to evaluate the ergonomic effectiveness of four wheelchair/vehicle transfer assistive devices, including (1) standard transfer board, (2) Glide n' Go, ( 3) Easy Reach Lift, and (4) Ryno Lift, and to compare them to an unassisted manual transfer. We have targeted persons with paraplegia (level of injury T2-L5) to standardize physical capabilities. Our research questions are:\n\n1. Evaluate the impact of vehicle/wheelchair transfers on objective measures of shoulder kinematics, kinetics, and muscle activity, for each of the participants.\n2. Evaluate the impact of vehicle/wheelchair transfers on subjective measures of shoulder pain, spasticity, perceived comfort, ease, efficiency, and safety.\n3. Examine the effects of covariates (patient characteristics, SCI characteristics and pain) on both objective and subjective outcome measures.\n\nBackground:\n\nUpper limb pain and injury are highly prevalent in persons with a spinal cord injury (SCI) who use a manual wheelchair for mobility. Historically, persons with paraplegia did not long survive the trauma of their injury, but with advances in medicine and emergency services, persons with SCI now have a life expectancy approaching that of the general population. For persons with paraplegia, paralysis of the lower limbs necessitates an over reliance on the upper limbs for performing wheelchair propulsion, transfers in/out of the wheelchair, and other mobility-related tasks. Many years of overuse of the upper extremities leads to an increased incidence of pain and cumulative trauma to the shoulders, elbows and wrists. Over 50% of persons with SCI have upper extremity pain; rotator cuff tears have been reported in 59-73%; and 40% have clinical evidence of carpal tunnel syndrome. Upper extremity deterioration following years of compensating for the lack of functional lower limbs in addition to their usual loading reduces quality of life, function, independence, and even life expectancy following SCI. The two most stressful mobility tasks performed by persons with paraplegia are wheelchair propulsion and wheelchair transfers. Several investigators have examined upper extremity kinematics (joint motions) kinetics (joint forces and torques), and muscle activity as determined by electromyography (EMG) among individuals with SCI during wheelchair propulsion. Comparatively few studies have addressed wheelchair transfers none of which offer an integrated kinematic, kinetic and EMG approach to simultaneously examine joint angles, moments and muscle activity.\n\nMethods:\n\nUsing Vicon motion analysis technology, we propose a laboratory-based randomized evaluation of five vehicle transfer approaches: unassisted manual transfer, standard transfer board, Glide n'Go, Easy Reach lift, and Ryno lift. The selected commercially-available products represent the range of assistive technologies presently available for this task.\n\nA sample of 58 veterans with paraplegia, who use a manual wheelchair for mobility, will be recruited to participate in this study. Subjects will be recruited from the Tampa VA Hospital by means of poster advertisement. Participants will complete data collection activities during one four-hour session, for which they will be compensated. Subjects will be asked to perform a series of five randomized wheelchair-to-vehicle transfer tasks. Vicon markers placed on the participant's body will capture positional data. Dynamic external loads exerted during the transfer tasks will be measured using AMTI MC3A tri-axial load cells strategically mounted in a vehicle mock-up. EMG will be recorded bilaterally for major muscle groups. Participants will complete subjective rating scales upon completion of each of the transfers.\n\nThe results of this study will be used to develop a clinical algorithm to assist clinicians with the selection of the most appropriate assistive technology for persons with disabilities who use a manual wheelchair for mobility. This algorithm will facilitate the individualized selection of assistive technologies that minimize risk for injury and maximize patient compliance, comfort, and satisfaction. The ultimate goal of this program of research is to (1) promote successful adaptation to aging with a disability, (2) reduce morbidity and mortality associated with wheelchair use, (3) enhance health-related quality of life, patient freedom, function, independence, and confidence, and (4) reduce healthcare utilization and associated costs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A sample of 58 veterans with paraplegia who use a rigid manual wheelchair will be recruited to participate in this study.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* level of SCI will be limited to ASIA A classification at T2 through L5 level to standardize physical capabilities,\n* SCI for at least 2 years (neurologically stable,\n* use rigid manual wheelchair as a primary means of mobility,\n* able to self-propel wheelchair,\n* able to independently transfer between wheelchair and vehicle,\n* between the ages of 18-65,\n* living in the community within 100 miles of the Tampa VA hospital,\n* able to follow simple instructions,\n* free from acute upper extremity injury for at least six months (determined by chart review) to minimize risk of injury during task performance,\n* comparable bilateral functional range of motion and strength of the shoulders, elbows and wrists (determined by physical evaluation) to minimize risk of injury during task performance.\n\nExclusion Criteria:\n\nCandidates who present:\n\n* progressive disease (e.g. spinal tumor),\n* extended bedrest for more than 30 days,\n* ventilator-dependent,\n* any cardiac or respiratory condition that would limit subject's physical performance,\n* unstable medical conditions,\n* use of power wheelchair or scooter as primary means of mobility,\n* pregnancy,\n* clinical evidence of severe musculoskeletal disorders of the upper extremity will be precluded from participating in this study."}, 'identificationModule': {'nctId': 'NCT00645567', 'briefTitle': 'Biomechanics of Wheelchair Transfers', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Evaluation of Transfer Technologies to Preserve Shoulder Function in SCI', 'orgStudyIdInfo': {'id': 'B6103-R'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Unassisted manual transfer', 'description': 'this group will use no additional aid in transfer.', 'interventionNames': ['Device: Unassisted Manual Transfer']}, {'label': 'Standard sliding board transfer', 'description': 'The standard transfer board is a flat surface board designed to bridge the gap that exists with transfers from wheelchair to vehicle and/or other horizontally displaced seating surfaces.', 'interventionNames': ['Device: Standard Transfer Board']}, {'label': "Glide n' Go Lift", 'description': "The Glide n' Go lift is a flip down power list seat that enables the person to enter and exit the vehicle by lifting them from their wheelchair up tot eh vehicle seat that they can make an easy transfer into the vehicle. Trunk stability may be required to successfully use the device.", 'interventionNames': ["Device: Glide n' Go"]}, {'label': 'Easy Reach lift', 'description': 'The Easy Reach lift seat allows the vehicles original seat to swivel out of the vehicle and lower to wheelchair height. the chair extends far from the vehicle to provide access for a safe, easy transfer.', 'interventionNames': ['Device: Easy Reach lift']}, {'label': 'Ryno lift', 'description': 'The Ryno lift is an under-vehicle list (UVL) system. Using this lift, the wheelchair user is raised into the vehicle cab using independent controls and can then maneuver into a convenient position in the cab. The wheelchair is locked down and the lift stored beneath the vehicle chassis. This technology eliminated the need to store and retrieve a wheelchair during transit.', 'interventionNames': ['Device: Ryno lift']}], 'interventions': [{'name': 'Unassisted Manual Transfer', 'type': 'DEVICE', 'description': 'No device assistance', 'armGroupLabels': ['Unassisted manual transfer']}, {'name': 'Standard Transfer Board', 'type': 'DEVICE', 'description': 'Flat surface board', 'armGroupLabels': ['Standard sliding board transfer']}, {'name': "Glide n' Go", 'type': 'DEVICE', 'description': 'Flip down power lift chair', 'armGroupLabels': ["Glide n' Go Lift"]}, {'name': 'Easy Reach lift', 'type': 'DEVICE', 'description': 'Original chair is converted to a chair that swivels out of the vehicle and lowers to wheelchair height', 'armGroupLabels': ['Easy Reach lift']}, {'name': 'Ryno lift', 'type': 'DEVICE', 'description': 'Lift for the wheelchair', 'armGroupLabels': ['Ryno lift']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612-4745', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "James A. Haley Veterans' Hospital", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'John D Lloyd, PhD BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "James A. Haley Veterans' Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}