Nctid:
NCT06234618
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D020521", "term"=>"Stroke"}], "ancestors"=>[{"id"=>"D002561", "term"=>"Cerebrovascular Disorders"}, {"id"=>"D001927", "term"=>"Brain Diseases"}, {"id"=>"D002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}, {"id"=>"D014652", "term"=>"Vascular Diseases"}, {"id"=>"D002318", "term"=>"Cardiovascular Diseases"}], "browseLeaves"=>[{"id"=>"M22306", "name"=>"Stroke", "asFound"=>"Stroke", "relevance"=>"HIGH"}, {"id"=>"M5810", "name"=>"Cerebrovascular Disorders", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"CROSS_SECTIONAL", "observationalModel"=>"CASE_ONLY"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>5}, "patientRegistry"=>false}, "statusModule"=>{"whyStopped"=>"The researchers would like to conduct a larger study and cover the contents of this study.", "overallStatus"=>"SUSPENDED", "startDateStruct"=>{"date"=>"2024-02-28", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-04", "completionDateStruct"=>{"date"=>"2024-06-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-04-10", "studyFirstSubmitDate"=>"2024-01-09", "studyFirstSubmitQcDate"=>"2024-01-28", "lastUpdatePostDateStruct"=>{"date"=>"2024-04-12", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-06-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"phase locking value", "timeFrame"=>"Real-time monitoring of electroencephalography data will occur while participants are walking. The Time Frame for data collection will encompass the entire duration of each participant's walking session, which lasts for 60 seconds.", "description"=>"used to evaluate the phase synchronization relationship between two signals."}, {"measure"=>"phase lag Index", "timeFrame"=>"Real-time monitoring of electroencephalography data will occur while participants are walking. The Time Frame for data collection will encompass the entire duration of each participant's walking session, which lasts for 60 seconds.", "description"=>"evaluate the degree of phase synchronization and the symmetry of neural oscillatory"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Electroencephalography", "walking", "visual deprivation"], "conditions"=>["Stroke"]}, "referencesModule"=>{"references"=>[{"pmid"=>"28679843", "type"=>"BACKGROUND", "citation"=>"Oliveira AS, Schlink BR, Hairston WD, Konig P, Ferris DP. Restricted vision increases sensorimotor cortex involvement in human walking. J Neurophysiol. 2017 Oct 1;118(4):1943-1951. doi: 10.1152/jn.00926.2016. Epub 2017 Jul 5."}], "seeAlsoLinks"=>[{"url"=>"http://pubmed.ncbi.nlm.nih.gov/28679843/", "label"=>"In this paper, the electroencephalography changes of normal people during visual deprivation walking were studied"}]}, "descriptionModule"=>{"briefSummary"=>"Post-stroke walking abnormalities present significant rehabilitation challenges. Visual deprivation training has been shown to be more effective than open-eye training. The investigators intend to examine the changes in electroencephalography patterns in stroke patients during visually deprived walking tasks.\n\nThe stroke participants will be fitted with a brain cap. The participants will walk with their eyes open for 60 seconds, and then their eyes will be blindfolded as they continue walking for another 60 seconds. Electroencephalography will monitor the signals in real-time during both walks.", "detailedDescription"=>"The electroencephalography data collection will be conducted in the Rehabilitation Department of Geriatric Hospital Affiliated with Nanjing Medical University. Upon commencing the experiment, participants will walk at a comfortable pace with their eyes open for a duration of 60 seconds. Following this initial test, a rest period of five minutes will be provided. For the visual deprivation walking trial, participants will be instructed to keep their eyes open throughout the trial. Investigators will apply an adequately sized blindfold to ensure complete visual deprivation, and the participants will proceed to walk for 60 seconds. During both trials, one investigator will remain one step behind the participant at all times to ensure safety."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"70 years", "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"stroke patients in a hospital inpatient unit", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Clinical diagnosis of stroke\n* Disease duration of more than 14 days\n* Ability to walk at least 10 m without assistance,\n\nExclusion Criteria:\n\n* Visual impairment\n* Severe cognitive impairment"}, "identificationModule"=>{"nctId"=>"NCT06234618", "briefTitle"=>"The Effect of Covered Eye Walking on Electroencephalogram in Stroke Patients Compared With Open Eye Walking", "organization"=>{"class"=>"OTHER", "fullName"=>"Nanjing Medical University"}, "officialTitle"=>"Study of Visual Deprivation on EEG Signal in Stroke Patients", "orgStudyIdInfo"=>{"id"=>"ZD2022065"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"stroke patients", "description"=>"Stroke patients who can walk without assistance in their daily life.", "interventionNames"=>["Other: visual deprivation"]}], "interventions"=>[{"name"=>"visual deprivation", "type"=>"OTHER", "description"=>"A group of patients walking with eyes open and walking with visual deprivation.", "armGroupLabels"=>["stroke patients"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Nanjing", "state"=>"Jiangsu", "country"=>"China", "facility"=>"Geriatric Hospital of Nanjing Medical University", "geoPoint"=>{"lat"=>32.06167, "lon"=>118.77778}}], "overallOfficials"=>[{"name"=>"Xia Li Zhang, doctor", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Geriatric Hospital of Nanjing Medical University"}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL", "SAP", "ICF", "CSR"], "timeFrame"=>"Three months after publication.", "ipdSharing"=>"YES", "description"=>"all IPD that underlie results in a publication.", "accessCriteria"=>"Request from the researchers by email."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Nanjing Medical University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Junior physiotherapist", "investigatorFullName"=>"Zhao Jing", "investigatorAffiliation"=>"Nanjing Medical University"}}}}
