Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2026-01-03 @ 9:19 PM
Study NCT ID:
NCT03427294
Status:
COMPLETED
Last Update Posted:
2023-01-27
First Post:
2018-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Delphi Study on Rehabilitation Following Lumbar Arthrodesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-26', 'studyFirstSubmitDate': '2018-01-26', 'studyFirstSubmitQcDate': '2018-02-02', 'lastUpdatePostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of perioperative rehabilitation following lumbar arthrodesis', 'timeFrame': 'January - December 2018', 'description': 'duration defined in amount of weeks'}, {'measure': 'Physiotherapeutic content following lumbar arthrodesis', 'timeFrame': 'January - December 2018', 'description': 'describing the physiotherapeutic modalities defined as manual therapy, exercise therapy, or cognitive behavioural therapy'}, {'measure': 'Frequency of physiotherapeutic intervention following lumbar arthrodesis', 'timeFrame': 'January - December 2018', 'description': 'frequency defined as amount of physiotherapeutic visits per week'}, {'measure': 'Multidisciplinary character of perioperative rehabilitation following lumbar arthrodesis', 'timeFrame': 'January - December 2018', 'description': 'amount and type of involved health care providers, as well as the interaction between'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lumbar Spine Degeneration', 'Physical Disability', 'Surgery']}, 'referencesModule': {'references': [{'pmid': '38816040', 'type': 'DERIVED', 'citation': 'Thys T, Bogaert L, Dankaerts W, Depreitere B, Van Wambeke P, Brumangne S, Bultheel M, Vanden Abeele V, Moke L, Spriet A, Schelfaut S, Janssens L, Swinnen TW. Qualitative study exploring the views of patients and healthcare providers on current rehabilitation practices after lumbar fusion surgery. BMJ Open. 2024 May 30;14(5):e077786. doi: 10.1136/bmjopen-2023-077786.'}]}, 'descriptionModule': {'briefSummary': 'Delphi study on perioperative rehabilitation after single and double level lumbar arthrodesis.', 'detailedDescription': 'The investigators aim to engage all care providers in Belgium and the Netherlands who are at some point involved in the rehabilitation path related to single and double level lumbar arthrodesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The investigators aim to engage all care providers (Belgium, the Netherlands) who are involved in the care of patients following lumbar arthrodesis.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The investigators aim to engage all care providers (Belgium, the Netherlands) who are involved in the care of patients following lumbar arthrodesis.\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT03427294', 'briefTitle': 'Delphi Study on Rehabilitation Following Lumbar Arthrodesis', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Delphi Study on Rehabilitation Following Lumbar Arthrodesis in UZ Leuven (Belgium)', 'orgStudyIdInfo': {'id': 'KU/UZ Leuven S60109 - 2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Care providers involved in lumbar arthrodesis', 'description': 'surgeons, physiotherapists, behavioral therapists, researchers, occupational therapists', 'interventionNames': ['Other: Delphi study']}], 'interventions': [{'name': 'Delphi study', 'type': 'OTHER', 'description': 'Delphi study on the optimal rehabilitation pathway following lumbar arthrodesis', 'armGroupLabels': ['Care providers involved in lumbar arthrodesis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams Brabant', 'country': 'Belgium', 'facility': 'UZ/KU Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Bart Depreitere, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}, {'name': 'Thijs Swinnen, MSc, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}, {'name': 'Tinne Thys, MSc, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}, {'name': 'Wim Dankaerts, PhD, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KU Leuven'}, {'name': 'Simon Brumagne, PhD, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KU Leuven'}, {'name': 'Peter Van Wambeke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}, {'name': 'Lieven Moke, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}, {'name': 'Sebastiaan Schelfaut, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}, {'name': 'Ann Spriet, MSc, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}, {'name': 'Lotte Janssens, PhD, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hasselt University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'UHasselt', 'class': 'UNKNOWN'}, {'name': 'KU Leuven', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}