Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-28 @ 11:55 AM
Study NCT ID:
NCT06162104
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2023-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Fatigue Severity, Mood, and Quality of Life in Post-Polio Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016262', 'term': 'Postpoliomyelitis Syndrome'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D011051', 'term': 'Poliomyelitis'}], 'ancestors': [{'id': 'D009187', 'term': 'Myelitis'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-18', 'studyFirstSubmitDate': '2023-11-30', 'studyFirstSubmitQcDate': '2023-11-30', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue Severity Scale', 'timeFrame': '0 day', 'description': 'This scale consists of 9 items assessing the severity of fatigue and its impact on individuals. Each item is scored on a scale ranging from 0 to 7.'}], 'secondaryOutcomes': [{'measure': 'Short Form-36', 'timeFrame': '0 day', 'description': 'This form comprises 36 items that inquire about the quality of life. Lower scores indicate a poorer condition.'}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': '0 day', 'description': 'This scale is a 14-item assessment method, consisting of 7 questions each, designed to inquire about symptoms related to anxiety and depression in patients. As the score increases, the level of anxiety and depression worsens.'}, {'measure': 'Visual Analogue Scale', 'timeFrame': '0 day', 'description': 'The Visual Analog Scale is a simple measurement tool consisting of a line with endpoints representing extreme points of a characteristic, such as "No Pain" to "Worst Pain Imaginable." Respondents mark a point on the line to indicate their perception or experience of the given characteristic.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Poliomyelitis', 'Fatigue', 'Postpoliomyelitis Syndrome'], 'conditions': ['Polio and Post-polio Syndrome', 'Fatigue', 'Polio']}, 'referencesModule': {'references': [{'pmid': '32790481', 'type': 'BACKGROUND', 'citation': 'Gusi N, Madruga M, Gonzalez-Gonzalez MLA, Perez-Gomez J, Prieto-Prieto J. Health-related quality of life and multidimensional fitness profile in polio survivors. Disabil Rehabil. 2022 Apr;44(8):1374-1379. doi: 10.1080/09638288.2020.1804629. Epub 2020 Aug 13.'}, {'pmid': '16931464', 'type': 'BACKGROUND', 'citation': 'On AY, Oncu J, Atamaz F, Durmaz B. Impact of post-polio-related fatigue on quality of life. J Rehabil Med. 2006 Sep;38(5):329-32. doi: 10.1080/16501970600722395.'}, {'pmid': '9790485', 'type': 'RESULT', 'citation': 'Bruno RL, Creange SJ, Frick NM. Parallels between post-polio fatigue and chronic fatigue syndrome: a common pathophysiology? Am J Med. 1998 Sep 28;105(3A):66S-73S. doi: 10.1016/s0002-9343(98)00161-2.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the differences in the severity of fatigue, impact on quality of life, and mood between individuals with post-polio syndrome and healthy volunteer groups. Additionally, the interrelationships of these parameters within the post-polio syndrome patient group will be examined. The goal is to raise awareness during the follow-up process for individuals with post-polio syndrome by questioning fatigue and mood symptoms, and to facilitate the implementation of necessary precautions.', 'detailedDescription': "Our research is designed as a case-control study. 20 patients diagnosed with post-polio syndrome who present to the Istanbul Physical Medicine and Rehabilitation Training and Research Hospital clinics and 20 healthy volunteers will be included in the study. The sociodemographic data of patients and volunteers, such as age, gender, height, weight, body mass index, education level, and occupation, will be recorded. The age at which polio was contracted, the time elapsed since polio, and any accompanying illnesses will be documented. Additionally, if patients experience new symptoms such as pain, weakness, or fatigue, the severity of these symptoms will be assessed using the Visual Analog Scale. The frequency of falls and the presence of fractures caused by falls, ambulation method, and devices used will be noted. Muscle weakness in the extremities will be identified by applying the Manual Muscle Test through physical examination. Subsequently, the patient's current symptoms related to depression and anxiety will be evaluated using the Hospital Anxiety and Depression Scale (HADS), fatigue level will be assessed using the Fatigue Severity Scale (FSS), and quality of life will be evaluated using the Short Form-36 (SF-36)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* Individuals aged between 18 and 60 with post-polio syndrome.\n* Healthy volunteers aged between 18 and 60', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals aged between 18 and 60 with post-polio syndrome.\n* Healthy volunteers aged between 18 and 60\n\nExclusion Criteria:\n\n* fibromyalgia,\n* chronic fatigue syndrome,\n* presence of chronic decompensated cardiac, renal, and hepatic insufficiency,\n* known psychiatric disorders,\n* rheumatological diseases,\n* presence of other known neurological diseases,\n* use of medications aimed at improving physical performance or alleviating fatigue.'}, 'identificationModule': {'nctId': 'NCT06162104', 'briefTitle': 'Evaluation of Fatigue Severity, Mood, and Quality of Life in Post-Polio Syndrome', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital'}, 'officialTitle': 'Evaluation of Fatigue Severity, Mood, and Quality of Life in Post-Polio Syndrome: A Controlled Study', 'orgStudyIdInfo': {'id': 'IstPRMTRH6'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Post-poliomyelitis syndrome group', 'description': 'Patients suffering from post-poliomyelitis syndrome', 'interventionNames': ['Other: No intervention']}, {'label': 'Healthy volunteers', 'description': 'Control gruoup with healthy volunteers', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Healthy volunteers', 'Post-poliomyelitis syndrome group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34147', 'city': 'Istanbul', 'state': 'Bahcelievler', 'country': 'Turkey (Türkiye)', 'facility': 'İstanbul Physical Medicine and Rehabilitation Research and Training Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34147', 'city': 'Istanbul', 'state': 'Beylikdüzü', 'country': 'Turkey (Türkiye)', 'facility': 'Beylikdüzü State Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}