Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 11:22 PM
Study NCT ID:
NCT00392860
Status:
COMPLETED
Last Update Posted:
2014-02-21
First Post:
2006-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Development of an Ergonomic Wheelchair Pushrim
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'boninger@upmc.edu', 'phone': '412-822-3700', 'title': 'Michael L Boninger', 'organization': 'Human Engineering Research Laboratories'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Natural-Fit Experiment', 'description': 'Participants will have a Natural-Fit installed on their wheelchair.\n\nNatural-Fit : Ergonomic handrim for wheelchairs', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Participants will be given a new standard handrim.', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Functional Status Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Natural-Fit Experiment', 'description': 'Participants will have a Natural-Fit handrim installed on their wheelchair.\n\nNatural-Fit : Ergonomic handrim for wheelchairs'}, {'id': 'OG001', 'title': 'Handrim Control Group', 'description': 'Participants will be given a new standard handrim.'}], 'timeFrame': 'Baseline, 4 Months', 'description': 'The Functional Status Scale, which measures hand and wrist symptoms.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed because only 4 participants were enrolled in this trial. Analyzing the results would not result in any meaningful information. The manufacturer of the PalmRim decided not to pursue the design and development of the product. As a result, the PalmRim experiment arm did not enroll any participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Natural-Fit Experiment', 'description': 'Participants will have a Natural-Fit handrim installed on their wheelchair. The Natural-Fit device was designed to directly address the shortcomings of standard handrims and to improve the standard round-tube handrims which were designed over 50 years ago.\n\nParticipants used the Natural-Fit Handrim for a four month trial period, before returning for follow up evaluations.\n\nNatural-Fit : Ergonomic handrim for wheelchairs'}, {'id': 'FG001', 'title': 'PalmRim Experiment', 'description': 'Participants will have a PalmRim handrim installed on their wheelchair. The PalmRim was designed for individuals who have limited hand function, making it difficult to grasp standard handrims.\n\nParticipants were to use the PalmRim handrim for a four month trial period, before returning for follow up evaluations.'}, {'id': 'FG002', 'title': 'Handrim Control Group', 'description': 'Participants will be given a new standard handrim.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from November 7, 2008 to April 8, 2009.', 'preAssignmentDetails': 'The manufacturer of the PalmRim decided not to pursue the design and development of the product. As a result, the PalmRim experiment arm did not enroll any participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Natural-Fit Experiment', 'description': 'Participants will have a Natural-Fit installed on their wheelchair.\n\nNatural-Fit : Ergonomic handrim for wheelchairs'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Participants will be given a new standard handrim.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48', 'spread': '2.11', 'groupId': 'BG000'}, {'value': '39', 'spread': '0', 'groupId': 'BG001'}, {'value': '46', 'spread': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-04', 'studyFirstSubmitDate': '2006-10-24', 'resultsFirstSubmitDate': '2013-06-18', 'studyFirstSubmitQcDate': '2006-10-24', 'lastUpdatePostDateStruct': {'date': '2014-02-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-01-04', 'studyFirstPostDateStruct': {'date': '2006-10-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Functional Status Score', 'timeFrame': 'Baseline, 4 Months', 'description': 'The Functional Status Scale, which measures hand and wrist symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Wheelchair', 'Handrims', 'Rehabilitation', 'Upper extremity'], 'conditions': ['Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the effectiveness of newly designed ergonomic manual wheelchair handrims called the Natural-Fit and PalmRim when compared to a new standard handrim. It is our hope that the new design of the handrims will help reduce upper extremity pain and injury, which is very common among manual wheelchair users. The Natural-Fit handrim was designed to directly address the shortcomings of standard handrims and to improve the standard-round tube handrims which were designed over 50 years ago. The PalmRim was designed for individuals who have limited hand function, making it difficult to grasp standard handrims.', 'detailedDescription': "This research will have three parts.\n\nThe first part will include completing propulsion and braking tasks with the subject's original handrims. After the initial testing, new handrims (NaturalFit, PalmRim, and a new standard handrim) will be installed on the subject's wheelchair and subjects will again be asked to complete another set of propulsion and braking tasks. Subjects will also be asked to complete a questionnaire to assess wrist and shoulder pain and undergo an examination of the condition of the palm of their hand.\n\nFor the second part of the study, subjects will be asked to participate in a 4-month trial use period of the new handrims on their wheelchair.\n\nIn the third part of the study, subjects will complete the final set of propulsion and braking tasks and complete a follow-up questionnaire."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Natural-Fit\n\nInclusion Criteria:\n\n* Use of a manual wheelchair as a primary means of mobility (over 40 hours per week)\n* Use a standard handrim\n* Between the ages of 18 and 55\n* Has normal hand function\n\nExclusion Criteria:\n\n* Pressure Sores\n\nPalmRim\n\nInclusion Criteria:\n\n* Use of a manual wheelchair as a primary means of mobility (over 40 hours per week)\n* Use a vinyl-coated handrim\n* Between ages 18 and 55\n* Has impaired hand function\n\nExclusion Criteria:\n\n* Pressure sores'}, 'identificationModule': {'nctId': 'NCT00392860', 'briefTitle': 'Development of an Ergonomic Wheelchair Pushrim', 'organization': {'class': 'FED', 'fullName': 'VA Pittsburgh Healthcare System'}, 'officialTitle': 'Development of an Ergonomic Manual Wheelchair Pushrim- Phase II', 'orgStudyIdInfo': {'id': '02484, 0511136'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PalmRim Experimental', 'description': 'Participants will have PalmRim installed on their wheelchair.', 'interventionNames': ['Device: PalmRim']}, {'type': 'EXPERIMENTAL', 'label': 'Natural-Fix Experiment', 'description': 'Participants will have a Natural-Fit installed on their wheelchair.', 'interventionNames': ['Device: Natural-Fit']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Handrim Control', 'description': 'Participants in this arm had a new standard handrim installed on their wheelchair as a control.', 'interventionNames': ['Device: Handrim Control Group']}], 'interventions': [{'name': 'Natural-Fit', 'type': 'DEVICE', 'description': 'Ergonomic handrim for wheelchairs', 'armGroupLabels': ['Natural-Fix Experiment']}, {'name': 'PalmRim', 'type': 'DEVICE', 'description': 'Ergonomic handrim for wheelchair', 'armGroupLabels': ['PalmRim Experimental']}, {'name': 'Handrim Control Group', 'type': 'DEVICE', 'description': 'Participants were given a new standard handrim to test. This intervention group is the control group.', 'armGroupLabels': ['Handrim Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15206', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Human Engineering Research Laboratories', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Michael L Boninger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh and VA Pittsburgh Healthcare System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Pittsburgh Healthcare System', 'class': 'FED'}, 'collaborators': [{'name': 'University of Pittsburgh', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair, Department of Physical Medicine and Rehabilitation', 'investigatorFullName': 'Michael Boninger', 'investigatorAffiliation': 'University of Pittsburgh'}}}}