Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2026-01-04 @ 5:39 PM
Study NCT ID:
NCT05833061
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2023-04-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
What is the Burden of Housing in Rural Areas for Individuals With Hemiplegia?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006429', 'term': 'Hemiplegia'}], 'ancestors': [{'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014894', 'term': 'Weights and Measures'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-02', 'studyFirstSubmitDate': '2023-04-16', 'studyFirstSubmitQcDate': '2023-04-16', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Stroke Self-Efficacy Questionnaire (SSEQ)', 'timeFrame': '1 day', 'description': "The Stroke Self-Efficacy Questionnaire (SSEQ) is a tool used to measure an individual's perceived self-efficacy or confidence in managing the consequences of a stroke. It consists of 13 items that assess an individual's ability to manage various stroke-related challenges, such as physical, emotional, and social difficulties. The SSEQ is designed to help healthcare professionals and researchers understand how an individual's perceived self-efficacy influences their ability to cope with the consequences of a stroke and manage their recovery effectively. By measuring an individual's perceived self-efficacy, the SSEQ can help identify areas where additional support and interventions may be needed to improve their overall recovery and quality of life."}, {'measure': 'The Stroke-Specific Quality of Life (SS-QoL) scale', 'timeFrame': '1 day', 'description': 'The Stroke-Specific Quality of Life (SS-QoL) scale is a questionnaire-based tool that is used to assess the quality of life of individuals who have experienced a stroke. It was developed to evaluate the impact of stroke on various domains of life, including physical, psychological, and social aspects. The SS-QoL scale contains 49 items, which are organized into 12 domains such as mobility, self-care, work/productivity, language, social roles, and emotional well-being. The scale has been validated and is widely used by healthcare professionals and researchers to assess the effectiveness of interventions and treatments for stroke patients, as well as to evaluate the long-term impact of stroke on their quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemiplegia']}, 'descriptionModule': {'briefSummary': 'Our objective is to examine the impact of residing in urban or rural areas on the utilization of healthcare services, self-efficacy, and quality of life among individuals with hemiplegia in Turkey.', 'detailedDescription': 'In this upcoming cross-sectional study, we will assess patients with hemiplegia who are scheduled to visit the physical medicine and rehabilitation outpatient clinic. Each participant will undergo a personal interview to fulfill the Stroke Self-Efficacy Questionnaire (SSEQ) and Stroke Specific Quality of Life Scale (SS-QOL). We will utilize the hospital database to determine the frequency of emergency department visits, physical medicine and rehabilitation outpatient clinic appointments, and general practitioner clinic visits specifically for hemiplegia in the previous year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Stroke patients who gave written consent to participate.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Stroke.\n* Giving consent.\n\nExclusion Criteria:\n\n* Not giving consent.\n* Inability to read and comprehend.\n* Severe cognitive impairments or communication difficulties.\n* Severe visual or motor impairments'}, 'identificationModule': {'nctId': 'NCT05833061', 'briefTitle': 'What is the Burden of Housing in Rural Areas for Individuals With Hemiplegia?', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Uskudar State Hospital'}, 'officialTitle': 'What is the Burden of Housing in Rural Areas for Individuals With Hemiplegia?', 'orgStudyIdInfo': {'id': 'BurdenSVO1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stroke Patients', 'description': 'Stroke patients giving written informed consent.', 'interventionNames': ['Other: The Stroke-Specific Quality of Life (SS-QoL) scale', 'Other: The Stroke Self-Efficacy Questionnaire (SSEQ)']}], 'interventions': [{'name': 'The Stroke-Specific Quality of Life (SS-QoL) scale', 'type': 'OTHER', 'description': 'The Stroke-Specific Quality of Life (SS-QoL) scale is a questionnaire-based tool that is used to assess the quality of life of individuals who have experienced a stroke. It was developed to evaluate the impact of stroke on various domains of life, including physical, psychological, and social aspects. The SS-QoL scale contains 49 items, which are organized into 12 domains such as mobility, self-care, work/productivity, language, social roles, and emotional well-being. The scale has been validated and is widely used by healthcare professionals and researchers to assess the effectiveness of interventions and treatments for stroke patients, as well as to evaluate the long-term impact of stroke on their quality of life.', 'armGroupLabels': ['Stroke Patients']}, {'name': 'The Stroke Self-Efficacy Questionnaire (SSEQ)', 'type': 'OTHER', 'description': "The Stroke Self-Efficacy Questionnaire (SSEQ) is a tool used to measure an individual's perceived self-efficacy or confidence in managing the consequences of a stroke. It consists of 13 items that assess an individual's ability to manage various stroke-related challenges, such as physical, emotional, and social difficulties. The SSEQ is designed to help healthcare professionals and researchers understand how an individual's perceived self-efficacy influences their ability to cope with the consequences of a stroke and manage their recovery effectively. By measuring an individual's perceived self-efficacy, the SSEQ can help identify areas where additional support and interventions may be needed to improve their overall recovery and quality of life.", 'armGroupLabels': ['Stroke Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Istanbul', 'state': 'Üsküdar', 'country': 'Turkey (Türkiye)', 'facility': 'Üsküdar State Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Mustafa H Temel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uskudar State Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD will be shared by the corresponding author upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uskudar State Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mustafa Hüseyin Temel', 'investigatorAffiliation': 'Uskudar State Hospital'}}}}