Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT03499951
Status:
COMPLETED
Last Update Posted:
2022-07-29
First Post:
2018-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Remote Wheelchair Skills Training Efficacy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-10', 'size': 545347, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-26T12:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-28', 'studyFirstSubmitDate': '2018-03-19', 'studyFirstSubmitQcDate': '2018-04-13', 'lastUpdatePostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in wheelchair skills capacity of trainees at study completion as measured by the Wheelchair Skills Test Questionnaire', 'timeFrame': 'Baseline, and at study completion ( an average of 3 weeks)', 'description': 'Trainees will have increased capacity to perform wheelchair skills after receiving one-on-one skills training.'}, {'measure': 'Change from baseline in wheelchair skills confidence of trainees at study completion as measured by the Wheelchair Skills Test Questionnaire', 'timeFrame': 'Baseline, and at study completion ( an average of 3 weeks)', 'description': 'Trainees will have increased confidence in their ability to perform wheelchair skills after receiving one-on-one skills training.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quality of life', 'Participation', 'Training'], 'conditions': ['Spinal Cord Injuries']}, 'referencesModule': {'references': [{'pmid': '34090853', 'type': 'DERIVED', 'citation': 'Worobey LA, Kirby RL, Cowan RE, Dyson-Hudson TA, Shea M, Heinemann AW, Pedersen JP, Boninger ML. Efficacy of a Remote Train-the-Trainer Model for Wheelchair Skills Training Administered by Clinicians: A Cohort Study With Pre- vs Posttraining Comparisons. Arch Phys Med Rehabil. 2022 Apr;103(4):798-806. doi: 10.1016/j.apmr.2021.03.042. Epub 2021 Jun 6.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the effectiveness of remote training to teach clinicians how to train others in wheelchair skills.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Age 18 to 75\n\nExclusion Criteria:\n\n• Upper or lower extremity injury that would preclude the ability to use a wheelchair.'}, 'identificationModule': {'nctId': 'NCT03499951', 'briefTitle': 'Remote Wheelchair Skills Training Efficacy', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Remote Wheelchair Skills Training Efficacy Coordinating Center', 'orgStudyIdInfo': {'id': 'PRO18010289'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Wheelchair Skills Trainers', 'description': 'Individuals will receive remotely delivered wheelchair skills training, after which they will be assessed on their ability to teach the Wheelchair Skills Trainees a series of wheelchair skills in a one-on-one environment. The intervention for this group is Wheelchair Skills Training - Remote.', 'interventionNames': ['Behavioral: Wheelchair Skills Training - Remote']}, {'type': 'OTHER', 'label': 'Wheelchair Skills Trainees', 'description': 'Individuals will receive one-on-one wheelchair skills training from the Wheelchair Skills Trainers. The intervention for this group is Wheelchair Skills Training - In Person.', 'interventionNames': ['Behavioral: Wheelchair Skills Training - In Person']}], 'interventions': [{'name': 'Wheelchair Skills Training - Remote', 'type': 'BEHAVIORAL', 'description': 'Individuals will receive wheelchair skills training remotely. They will be provided with the Wheelchair Skills Training Program to review (http://www.wheelchairskillsprogram.ca/eng/index.php), and then will be directed to use this information to perform the wheelchair skills. They will video the attempts, and will receive feedback on methods to improve their techniques.', 'armGroupLabels': ['Wheelchair Skills Trainers']}, {'name': 'Wheelchair Skills Training - In Person', 'type': 'BEHAVIORAL', 'description': 'Individuals will receive wheelchair skills training in one-on-one sessions, taught by those who received the wheelchair skills training remotely.', 'armGroupLabels': ['Wheelchair Skills Trainees']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'South Florida Spinal Cord Injury System', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Midwest Regional Spinal Cord Injury Care System', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '07052', 'city': 'West Orange', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Northern New Jersey Spinal Cord System', 'geoPoint': {'lat': 40.79871, 'lon': -74.23904}}, {'zip': '15219', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Model Center on Spinal Cord Injury', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Michael Boninger, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share IPD outside of collaborators.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'U.S. Department of Education', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and UPMC Endowed Vice Chair for Research', 'investigatorFullName': 'Michael Boninger', 'investigatorAffiliation': 'University of Pittsburgh'}}}}