Nctid:
NCT06233682
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000020521", "term"=>"Stroke"}], "ancestors"=>[{"id"=>"D000002561", "term"=>"Cerebrovascular Disorders"}, {"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "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"}, {"id"=>"T170", "name"=>"Acute Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SEQUENTIAL", "interventionModelDescription"=>"Longitudinal interventional study in which participants are not randomised, as the experimental design alternates sequentially between the control and experimental groups, with no possibility of interaction between the two groups."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>70}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-06", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-05", "completionDateStruct"=>{"date"=>"2025-06", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-05-21", "studyFirstSubmitDate"=>"2023-11-27", "studyFirstSubmitQcDate"=>"2024-01-27", "lastUpdatePostDateStruct"=>{"date"=>"2024-05-22", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Stroke Impact Scale", "timeFrame"=>"T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (follow up visit), T3: 6 months post intervention (telephone interview)", "description"=>"The Stroke Impact Scale (SIS) is a self-report questionnaire that evaluates disability and health-related quality of life after stroke. SIS is a 59-item measure. Each item is rated in a 5-point Likert scale in terms of the difficulty the patient has experienced in completing each item. Summative scores are generated for each domain, scores range from 0-100."}], "secondaryOutcomes"=>[{"measure"=>"Functional Independence Measure (FIM) scale", "timeFrame"=>"T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (follow up visit), T3: 6 months post intervention (telephone interview)", "description"=>"Functional Independence Measure (FIM) scale is used to assess and grade the functional status of a person based on the level of assistance he or she requires. FIM is comprised of 18 items, grouped into 2 subscales - motor and cognition. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. The total score for the FIM instrument (the sum of the motor and cognition subscale scores) will be a value between 18 and 126."}, {"measure"=>"Action Research Arm Test (ARAT)", "timeFrame"=>"T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (follow up visit)", "description"=>"The Action Research Arm Test (ARAT) is a 19-item measure aimed at assessing functional performance of the upper extremity through observational means. The ARAT is divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3) Performs test normally; 2) Completes test, but takes abnormally long or has great difficulty; 1) Performs test partially; 0) Can perform no part of test. The maximum score on the ARAT is 57 points (possible range 0 to 57). A higher score indicates greater functioning in the upper extremity."}, {"measure"=>"Functional Ambulatory Category (FAC)", "timeFrame"=>"T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (follow up visit), T3: 6 months post intervention (telephone interview)", "description"=>"The Functional Ambulation Categories (FAC) is a 6-point functional walking test that evaluates ambulation ability, determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. Scoring range from 0: nonfunctional ambulator to 5: Ambulator, independent."}, {"measure"=>"Dynamic Gait Index (DGI) if FAC > 3", "timeFrame"=>"T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (follow up visit)", "description"=>"The Dynamic Gait Index (DGI) is a clinical tool used to assess gait, balance and fall risk. It evaluates not only the usual steady-state walking, but also walking during more challenging tasks. Scores are based on a 4-point scale. Highest possible score is 24 points."}, {"measure"=>"Bedside examination (ELLM)", "timeFrame"=>"T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (follow up visit)", "description"=>"Clinical examination assessing communication and cognitive functions"}, {"measure"=>"Oxford Cognitive Screening (OCS)", "timeFrame"=>"T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (follow up visit)", "description"=>"The Oxford Cognitive Screen (OCS) is a first-line, stroke-specific and domain-specific cognitive screening tool which can be delivered at the bedside in acute stroke."}, {"measure"=>"Typical values of Physical Activity Level (PAL)", "timeFrame"=>"T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (follow up visit), T3: 6 months post intervention (telephone interview)", "description"=>"The physical activity level (PAL) is a way to express a person's daily physical activity as a number, and is used to estimate a person's total energy expenditure. Ranges: Extremely inactive PAL \\<1.40 - Extremely active PAL \\>2.40."}, {"measure"=>"Hospital Anxiety and Depression Scale (HADS)", "timeFrame"=>"T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (follow up visit), T3: 6 months post intervention (telephone interview)", "description"=>"Hospital Anxiety and Depression Scale (HADS) is used to determine the levels of anxiety and depression. The HADS is a fourteen item scale. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression."}, {"measure"=>"Ad hoc behavioral mapping checklist", "timeFrame"=>"T0: baseline (enrollment), T1: immediately after intervention (discharge)", "description"=>"Tool created to quantify and study the type of activity (physical, cognitive, social) carried out by participants."}, {"measure"=>"Ad hoc questionnaire for health care workers", "timeFrame"=>"T1: post intervention", "description"=>"Assessing impact on ward organisation."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["enriched environment", "in-patients setting"], "conditions"=>["Stroke", "Stroke, Acute"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this longitudinal interventional study is to integrate the enriched environment (EE) in the context of the Neurology Clinic ward of the General Hospital - University of Padua, by verifying its effectiveness and impact on psychological well-being, functional recovery, activity level, and quality of life in people with stroke.", "detailedDescription"=>"The EE will be integrated within the shared areas of the Neurology ward and in inpatient rooms, providing materials and aids to encourage physical, cognitive and social activity. The study will recruit for 9 months plus 6 months of follow-up. It will recruited a total of 70 people with stroke (35 for experimental and control group). After providing informed consent, participants will be evaluated on admission, at discharge, at 4 weeks (follow-up visit) and at 6 months (telephone interview). Participants will be psuedo randomized, as the ward will be environmentally enriched during consecutive alternating time frames. The instrument used to measure the multidimensional recovery will be the Stroke Impact Scale. Specific secondary outcomes will assessed the recovery in motor, cognitive and communication function, the impact on physical activity, mood, the type of activity of participants exposed to EE and the impact on the ward organization."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Ischaemic or haemorrhagic stroke, in any territory, occurring at least 24 hours before enrollment;\n* Participant consent to participate in the study;\n* Mecial stabilisation.\n\nExclusion Criteria:\n\n* Uncooperative participant, as assessed by theMontreal Cognitive Assessment scale \\< 15\n* medically not stabtability and/or reduced level of consciousness and/or psychomotor agitation;\n* Lack of trunk control (score \\<12 in item 3 of the Trunk Control Test: balance in sitting position) such that it is impossible to maintain a sitting position or a safe posture in a wheelchair;\n* Speech evaluation confirming comprehension aphasia hampering understanding of informed consent."}, "identificationModule"=>{"nctId"=>"NCT06233682", "acronym"=>"ENVIRONMENT", "briefTitle"=>"The Enriched Environment as an Integrated Tool in the Ward Setting", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Padova"}, "officialTitle"=>"The Enriched Environment as an Integrated Tool in the Ward Setting for Improving Functional Outcome in People With Acute Stroke: a Study Within the Neurological Clinic Unit", "orgStudyIdInfo"=>{"id"=>"PROTOCOL_ENVIRONMENT"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Enriched environment group", "description"=>"35 people with stroke recruited from the in-patient ward of the Neurology Clinic, meeting the inclusion criteria.", "interventionNames"=>["Other: Enriched environment"]}, {"type"=>"NO_INTERVENTION", "label"=>"No intervention", "description"=>"35 people with stroke recruited from the in-patient ward of the Neurology Clinic, meeting the inclusion criteria."}], "interventions"=>[{"name"=>"Enriched environment", "type"=>"OTHER", "description"=>"In the experimental group (enriched environment), assistants will supervise participants sponatneoulsy engaging in activities, including listening to music, drawing, playing cards or board games, exercising the affected upper limb with constructions or puzzles, etc., in the living room and personal rooms. Posters and clocks will also aid in orientation and improve the physical environment.", "armGroupLabels"=>["Enriched environment group"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Francesca Venturini", "role"=>"CONTACT", "email"=>"ce.sperimentazione@aopd.veneto.it", "phone"=>"049 8212341"}], "overallOfficials"=>[{"name"=>"Alessandra Del Felice, MD, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Padova"}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL", "CSR"], "timeFrame"=>"Upon study completion", "ipdSharing"=>"YES", "description"=>"Anonymized data sheet", "accessCriteria"=>"Upon direct request of researchers providing any official reaserch identification (ORCID, Reaserch ID, etc)"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Padova", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Associate Professor of Physical and Rehabilitation Medicine", "investigatorFullName"=>"Alessandra Del Felice", "investigatorAffiliation"=>"University of Padova"}}}}
