Nctid:
NCT06230718
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M5207", "name"=>"Brain Injuries", "relevance"=>"LOW"}, {"id"=>"M22306", "name"=>"Stroke", "relevance"=>"LOW"}, {"id"=>"T6034", "name"=>"Quality of Life", "asFound"=>"Quality of Life", "relevance"=>"HIGH"}, {"id"=>"T1525", "name"=>"Congenital Mirror Movement Disorder", "asFound"=>"Mirror Movement", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE", "maskingDescription"=>"Patients will receive 3 interventions: placebo, motor imagery and action observation"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>28}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-01-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-01-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-29", "studyFirstSubmitDate"=>"2024-01-19", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-01-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Disability and Dependence Level - Barthel Index", "timeFrame"=>"Administered once, typically taking a few minutes.", "description"=>"A general measure assessing patient independence, evaluating performance in basic daily activities (ADLs)."}, {"measure"=>"Upper Limb Functionality - Action Research Arm Test (ARAT)", "timeFrame"=>"Administration time ranges from 5 to 15 minutes.", "description"=>"Assesses upper limb functionality post-cortical injury, involving manipulation tasks with various objects."}, {"measure"=>"Cognitive Impairment - Montreal Cognitive Assessment (MoCA)", "timeFrame"=>"takes about 10 minutes for administration.", "description"=>"Evaluates mild cognitive dysfunctions across multiple domains, including attention, memory, language, and executive functions."}, {"measure"=>"Perception Impairment - Loewenstein Occupational Therapy Cognitive Assessment (LOTCA)", "timeFrame"=>"Duration varies based on the number and type of subtests administered.", "description"=>"Specific for occupational therapy in stroke patients, assessing visual, spatial, motor, and cognitive perception."}, {"measure"=>"Mental Evocation Ability - Mental Evocation of Images, Movements, and Activities Questionnaire (CEMIMA)", "timeFrame"=>"Duration varies", "description"=>"Measures the ability to mentally form visual and kinesthetic images of the hand/upper limb."}, {"measure"=>"Quality of Life Perception - Stroke Impact Scale 16 (SIS-16)", "timeFrame"=>"5-10 minutes.", "description"=>"A self-report measure focusing on physical aspects including strength, hand function, mobility, and ADLs."}, {"measure"=>"Electromyographic Activity During MI and AO", "timeFrame"=>"during the experimental setup", "description"=>"muscle activity using surface electrodes on wrist extensors and flexors."}], "secondaryOutcomes"=>[{"measure"=>"Age", "timeFrame"=>"1 minute", "description"=>"birth age"}, {"measure"=>"gender", "timeFrame"=>"1 minute", "description"=>"he gender with which the participant identifies"}, {"measure"=>"Marital Status", "timeFrame"=>"1 minute", "description"=>"single, married, divorced"}, {"measure"=>"Education Level", "timeFrame"=>"1 minute", "description"=>"he highest level of education"}, {"measure"=>"Economic Status", "timeFrame"=>"1 minute", "description"=>"participant's economic"}, {"measure"=>"Affected Side", "timeFrame"=>"1 minute", "description"=>"The side of the body affected by the stroke or injury"}, {"measure"=>"Dominant Side", "timeFrame"=>"1 minute", "description"=>"The side of the body that is the participant's natural dominant side"}, {"measure"=>"Type of Lesion", "timeFrame"=>"1 minute", "description"=>"specific type of brain injury"}, {"measure"=>"Time Since Injury", "timeFrame"=>"1 minute", "description"=>"time since the participant had the brain injury or stroke."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Stroke rehabilitation", "Electromyography", "Neuroplasticity", "Upper Linb", "Neurorehabilitation"], "conditions"=>["Stroke", "Quality of Life", "Mirror Movement"]}, "descriptionModule"=>{"briefSummary"=>"This study focuses on electromyographic analysis of upper limb muscle activation in stroke survivors during Motor Imagery (MI) and Action Observation (AO) rehabilitation techniques. By measuring muscle activity in the wrist and finger flexors and extensors, the research seeks to understand the impact of MI and AO on motor function recovery post-stroke. Conducted at the University of Salamanca, the study involves stroke survivors participating in a series of three experimental sessions. The analysis will correlate electromyographic responses with functional independence, limb functionality, and cognitive factors. The research aims to contribute to the fields of occupational therapy and physiotherapy, offering insights into effective rehabilitation methods for improving quality of life in stroke survivors.", "detailedDescription"=>"This study investigates muscle activation in the upper limbs of stroke survivors using electromyographic analysis during Motor Imagery (MI) and Action Observation (AO). Stroke, a major cause of disability, often results in motor impairments in the upper limb, impacting daily activities. The research focuses on innovative rehabilitation techniques based on neuroplasticity, such as MI and AO, stimulated by the discovery of mirror neurons.\n\nThe primary goal is to record upper limb muscle activation during MI and AO, using surface electromyography to measure activation in wrist and finger flexors and extensors. The study will also explore the relationship between electromyographic responses and factors like daily activity independence, limb functionality, quality of life, mental evocation ability, and cognitive impairment.\n\nConducted at the University of Salamanca, the study will recruit stroke survivors for a three-session experimental protocol involving control, MI, and AO conditions. Data will be analyzed with SPSS Statistics, ensuring anonymity and ethical compliance. The research aims to enhance understanding of effective neurorehabilitation techniques, contributing to the fields of occupational therapy and physiotherapy."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"99 years", "minimumAge"=>"18 years", "genderBased"=>true, "genderDescription"=>"Data collection forms include gender identity questions, and the gender identity is sellf-determined by participants", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Being over 18 years of age\n* Diagnoses of established stroke\n* Present limitations or motor response deficiencies in the upper limb\n* Maintain cognitive functions with the ability to follow the instructions of the interventions and evaluations (MOCA\\>14)\n\nExclusion Criteria:\n\n* Diagnosed with mental illness before the stroke\n* Other systemic conditions on the central nervous system\n* Cardiorespiratory system pathologies in severe cases\n* Acute period, fever, muscle inflammation or myopathies\n* Any type of vascular and organic insufficiency\n* Liver disease or skin lesions in the area of application of the electrodes."}, "identificationModule"=>{"nctId"=>"NCT06230718", "briefTitle"=>"EMG Analysis in ABI: Motor Imagery and Action", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Salamanca"}, "officialTitle"=>"Upper Limb Electromyographic Response to Motor Imagery and Action Observation in Acquired Brain Injury Patients.", "orgStudyIdInfo"=>{"id"=>"MIAO"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Intervention group", "description"=>"The intervention group will receive 3 experimental procedures\n\n1. Placebo control\n2. Motor Imagery- Active Comparator\n3. Action Observation (OA) Active comparator muscle activation control by surface electromyography will be recorded in these three situations", "interventionNames"=>["Other: Motor Imagery (MI)", "Other: Action Observation (AO)", "Other: Control condition- placebo"]}], "interventions"=>[{"name"=>"Motor Imagery (MI)", "type"=>"OTHER", "description"=>"mental process where an individual visualizes or imagines themselves performing a movement without actually executing it physically. This cognitive process involves the mental rehearsal of motor actions, engaging similar neural pathways that are used when physically performing the action.", "armGroupLabels"=>["Intervention group"]}, {"name"=>"Action Observation (AO)", "type"=>"OTHER", "description"=>"rehabilitation technique based on the principle of observing actions to improve motor function and learning. This approach is rooted in the concept of the mirror neuron system, a group of neurons that are activated both when a person performs an action and when they observe the same action performed by others.", "armGroupLabels"=>["Intervention group"]}, {"name"=>"Control condition- placebo", "type"=>"OTHER", "description"=>"Recording with images of landscapes without the presence of any person or animal that could evoke MI or OA.", "armGroupLabels"=>["Intervention group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"37007", "city"=>"Salamanca", "status"=>"RECRUITING", "country"=>"Spain", "contacts"=>[{"name"=>"Beatriz María Bermejo Gil, Dr.", "role"=>"CONTACT", "email"=>"beatriz.bermejo@usal.es", "phone"=>"622289468"}, {"name"=>"Ana María Martín Nogueras", "role"=>"CONTACT", "email"=>"anamar@usal.es", "phone"=>"677510296"}, {"name"=>"Sara Santiago Marín, Phd Student", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"AnaBelen Calvo Vera, Dr", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"Beatriz María Bermejo Gil, Dr", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"Ana María Martín Nogueras, Dr", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Universidad de Salmanca", "geoPoint"=>{"lat"=>40.96882, "lon"=>-5.66388}}], "centralContacts"=>[{"name"=>"Beatriz María Bermejo Gil, Dr", "role"=>"CONTACT", "email"=>"beatriz.bermejo@usal.es", "phone"=>"622289468"}, {"name"=>"Ana MAría Martín Nogueras, Dr", "role"=>"CONTACT", "email"=>"anamar@usal.es", "phone"=>"677510296"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Salamanca", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Ana María Martín Nogueras", "investigatorAffiliation"=>"University of Salamanca"}}}}
