Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-02-20 @ 1:58 AM
Study NCT ID:
NCT03321357
Status:
COMPLETED
Last Update Posted:
2018-07-13
First Post:
2017-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retest-reliability and At-home-assessment Feasibility of the 5R-STS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}, {'id': 'D013168', 'term': 'Spondylolisthesis'}, {'id': 'D055009', 'term': 'Spondylosis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013169', 'term': 'Spondylolysis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-12', 'studyFirstSubmitDate': '2017-10-23', 'studyFirstSubmitQcDate': '2017-10-23', 'lastUpdatePostDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '5R-STS', 'timeFrame': '0 months', 'description': 'Objective functional test measuring the amount of functional impairment.'}], 'secondaryOutcomes': [{'measure': 'EQ-5D-3L', 'timeFrame': '0 months', 'description': 'Validated questionnaire measuring quality of life'}, {'measure': 'Oswestry Disability Index', 'timeFrame': '0 months', 'description': 'Validated questionnaire measuring functional disability'}, {'measure': 'VAS leg pain severity', 'timeFrame': '0 months', 'description': 'Validated questionnaire measuring pain'}, {'measure': 'VAS back pain severity', 'timeFrame': '0 months', 'description': 'Validated questionnaire measuring pain'}, {'measure': 'Roland Morris Disability Questionnaire', 'timeFrame': '0 months', 'description': 'Validated questionnaire measuring functional disability'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Degenerative Disc Disease', 'Spondylolisthesis', 'Spondylosis', 'Herniated Nucleus Pulposus', 'Spinal Stenosis Lumbar', 'Spinal Diseases', 'Spinal Instability']}, 'referencesModule': {'references': [{'pmid': '23783372', 'type': 'RESULT', 'citation': 'Jones SE, Kon SS, Canavan JL, Patel MS, Clark AL, Nolan CM, Polkey MI, Man WD. The five-repetition sit-to-stand test as a functional outcome measure in COPD. Thorax. 2013 Nov;68(11):1015-20. doi: 10.1136/thoraxjnl-2013-203576. Epub 2013 Jun 19.'}, {'pmid': '36477416', 'type': 'DERIVED', 'citation': 'Klukowska AM, Staartjes VE, Vandertop WP, Schroder ML. Predictors of five-repetition sit-to-stand test performance in patients with lumbar degenerative disease. Acta Neurochir (Wien). 2023 Jan;165(1):107-115. doi: 10.1007/s00701-022-05441-1. Epub 2022 Dec 7.'}, {'pmid': '31451936', 'type': 'DERIVED', 'citation': 'Staartjes VE, Klukowska AM, Schroder ML. Association of maximum back and leg pain severity with objective functional impairment as assessed by five-repetition sit-to-stand testing: analysis of two prospective studies. Neurosurg Rev. 2020 Oct;43(5):1331-1338. doi: 10.1007/s10143-019-01168-3. Epub 2019 Aug 26.'}, {'pmid': '30680635', 'type': 'DERIVED', 'citation': 'Staartjes VE, Beusekamp F, Schroder ML. Can objective functional impairment in lumbar degenerative disease be reliably assessed at home using the five-repetition sit-to-stand test? A prospective study. Eur Spine J. 2019 Apr;28(4):665-673. doi: 10.1007/s00586-019-05897-3. Epub 2019 Jan 24.'}]}, 'descriptionModule': {'briefSummary': 'The five-repetition sit-to-stand test has been validated and is used primarily in pulmonary medicine and cardiology, and has recently been shown to be a useful tool for the objective assessment of functional impairment in patients with degenerative diseases of the lumbar spine.\n\nThe goal of this study is to assess the possibility of supervised and unsupervised at-home-assessment. Validation of at-home-assessment would allow the 5R-STS to be easily used as a follow-up tool in clinical trials, for example.', 'detailedDescription': 'Patients will perform three 5R-STS measurements:\n\n1. During outpatient clinics, time measured by the physician\n2. At home, time measured by partner/family\n3. At home, and assessed by producing a video recording of the 5R-STS performance that is subsequently sent and analyzed (time measured digitally)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with symptomatic degenerative diseases of the lumbar spine that come in for surgical treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Degenerative diseases of the lumbar spine (Herniated disc, lumbar stenosis, spondylolisthesis, degenerative disc disease)\n* Symptoms of lower back pain, neurogenic claudication, or radiculopathy\n\nExclusion Criteria:\n\n* Hip or Knee prosthetics\n* Walking aides'}, 'identificationModule': {'nctId': 'NCT03321357', 'acronym': '5RSTS-2', 'briefTitle': 'Retest-reliability and At-home-assessment Feasibility of the 5R-STS', 'organization': {'class': 'OTHER', 'fullName': 'Bergman Clinics'}, 'officialTitle': 'Test-retest-reliability and At-home-assessment Feasibility of the Five-repetition Sit-to-stand Test (5R-STS)', 'orgStudyIdInfo': {'id': '5R-STS-2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'five-repetition sit-to-stand test', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['5R-STS'], 'description': "An armless chair with a hard seat was stabilised by placing it against a wall. Seated participants were asked to come forward on the chair seat until the feet were flat on the floor and to fold their upper limbs across the chest. Participants were then instructed to stand up all the way and sit down once without using the upper limbs. For those unable to complete the initial manoeuvre or who required assistance, the test was terminated. If successful on the initial sit to stand, participants were then asked to stand up all the way and sit down landing firmly, as fast as possible, five times without using the arms. Timing with a stopwatch was started on the command 'go' and stopped at the end of the completed fifth stand; the time taken was recorded as the participant's score.\n\n(1) Jones et al."}]}, 'contactsLocationsModule': {'locations': [{'zip': '1411 GE', 'city': 'Naarden', 'country': 'Netherlands', 'facility': 'Bergman Clinics', 'geoPoint': {'lat': 52.29583, 'lon': 5.1625}}], 'overallOfficials': [{'name': 'Victor E. Staartjes, MSIII', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurosurgery, Bergman Clinics, Naarden, The Netherlands'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bergman Clinics', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Marc Schröder', 'investigatorAffiliation': 'Bergman Clinics'}}}}