Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-02-21 @ 10:34 AM
Study NCT ID:
NCT06349603
Status:
COMPLETED
Last Update Posted:
2024-04-05
First Post:
2024-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiotherapy Approach for Susac Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055955', 'term': 'Susac Syndrome'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D015356', 'term': 'Retinal Artery Occlusion'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D005132', 'term': 'Eye Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2024-03-29', 'studyFirstSubmitQcDate': '2024-04-04', 'lastUpdatePostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mobility and Muscle Strength Improvement', 'timeFrame': 'Assessed at baseline and after 12 weeks of intensive therapy.', 'description': 'This outcome measure evaluates improvements in mobility in a single individual with Susac syndrome following 12 weeks of intensive physiotherapy. Assessments include the Timed Up and Go test (TUG), which measures the time taken for the individual to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. Progress is indicated by the transition from heavy reliance on assistance for mobility to independent walking for 100 meters.'}, {'measure': 'Muscle Strength Improvement Outcome Measure', 'timeFrame': 'Assessed at baseline and after 12 weeks of intensive therapy.', 'description': 'This outcome measure evaluates improvements in muscle strength in a single individual with Susac syndrome following 12 weeks of intensive physiotherapy. Assessments include manual muscle tests (MMT) to assess the strength and function of specific muscle groups, using a standardized grading scale. Progress is indicated by higher grades in manual muscle tests, reflecting improved muscle strength and endurance.'}, {'measure': 'Pain Intensity Outcome Measure', 'timeFrame': 'Assessed at baseline and after 12 weeks of intensive therapy.', 'description': 'This outcome measure evaluates changes in pain intensity experienced by the individual with Susac syndrome following 12 weeks of intensive physiotherapy. Pain intensity is assessed using the Visual Analog Scale (VAS), where the individual rates their pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain. Progress is indicated by a decrease in VAS scores, reflecting reduced pain intensity.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physiotherapy'], 'conditions': ['Susac Syndrome']}, 'referencesModule': {'references': [{'pmid': '36110471', 'type': 'BACKGROUND', 'citation': "Ahmad A, Tariq F, Zaheer M. Incomplete Susac's Syndrome: A Case Report and Literature Review. Cureus. 2022 Aug 11;14(8):e27903. doi: 10.7759/cureus.27903. eCollection 2022 Aug."}, {'pmid': '37608221', 'type': 'BACKGROUND', 'citation': 'Bose S, Papathanasiou A, Karkhanis S, Appleton JP, King D, Batra R, Mollan SP, Jacob S. Susac syndrome: neurological update (clinical features, long-term observational follow-up and management of sixteen patients). J Neurol. 2023 Dec;270(12):6193-6206. doi: 10.1007/s00415-023-11891-z. Epub 2023 Aug 22.'}, {'pmid': '31248864', 'type': 'BACKGROUND', 'citation': 'Coulette S, Lecler A, Saragoussi E, Zuber K, Savatovsky J, Deschamps R, Gout O, Sabben C, Aboab J, Affortit A, Charbonneau F, Obadia M. Diagnosis and Prediction of Relapses in Susac Syndrome: A New Use for MR Postcontrast FLAIR Leptomeningeal Enhancement. AJNR Am J Neuroradiol. 2019 Jul;40(7):1184-1190. doi: 10.3174/ajnr.A6103. Epub 2019 Jun 27.'}, {'pmid': '38434197', 'type': 'BACKGROUND', 'citation': 'Cvikova M, Stefela J, Vsiansky V, Dufek M, Dolezalova I, Vinklarek J, Herzig R, Zemanova M, Cervenak V, Brichta J, Barkova V, Kouril D, Aulicky P, Filip P, Weiss V. Case report: Susac syndrome-two ends of the spectrum, single center case reports and review of the literature. Front Neurol. 2024 Feb 16;15:1339438. doi: 10.3389/fneur.2024.1339438. eCollection 2024.'}, {'pmid': '35413469', 'type': 'BACKGROUND', 'citation': 'David C, Sacre K, Henri-Feugeas MC, Klein I, Doan S, Cohen FA, Jouvent E, Papo T. Susac syndrome: A scoping review. Autoimmun Rev. 2022 Jun;21(6):103097. doi: 10.1016/j.autrev.2022.103097. Epub 2022 Apr 10.'}, {'pmid': '29933288', 'type': 'BACKGROUND', 'citation': 'Egan RA. Diagnostic Criteria and Treatment Algorithm for Susac Syndrome. J Neuroophthalmol. 2019 Mar;39(1):60-67. doi: 10.1097/WNO.0000000000000677.'}, {'pmid': '31534817', 'type': 'BACKGROUND', 'citation': 'Luan X, Tian X, Zhang H, Huang R, Li N, Chen P, Wang R. Exercise as a prescription for patients with various diseases. J Sport Health Sci. 2019 Sep;8(5):422-441. doi: 10.1016/j.jshs.2019.04.002. Epub 2019 Apr 18.'}, {'pmid': '37252530', 'type': 'BACKGROUND', 'citation': 'Masjuan M, Ivanovski T, Sarasibar Ezcurra H, Rigo Oliver E. Behavioral Impairment and Amnesia at the Onset of Susac Syndrome. Cureus. 2023 Apr 25;15(4):e38089. doi: 10.7759/cureus.38089. eCollection 2023 Apr.'}, {'pmid': '33948430', 'type': 'BACKGROUND', 'citation': 'Patil S, Gs V, Sarode GS, Sarode SC, Khurayzi TA, Mohamed Beshir SE, Gadbail AR, Gondivkar S. Exploring the role of immunotherapeutic drugs in autoimmune diseases: A comprehensive review. J Oral Biol Craniofac Res. 2021 Apr-Jun;11(2):291-296. doi: 10.1016/j.jobcr.2021.02.009. Epub 2021 Feb 23.'}, {'pmid': '33408428', 'type': 'BACKGROUND', 'citation': "Pereira S, Vieira B, Maio T, Moreira J, Sampaio F. Susac's Syndrome: An Updated Review. Neuroophthalmology. 2020 May 1;44(6):355-360. doi: 10.1080/01658107.2020.1748062. eCollection 2020."}, {'pmid': '34567813', 'type': 'BACKGROUND', 'citation': 'Reedy MB, Wang Y, Beinlich BR, Rose WN. Successful Treatment of Incomplete Susac Syndrome with Simultaneous Corticosteroids and Plasmapheresis Followed by Rituximab. Case Rep Neurol Med. 2021 Aug 12;2021:5591559. doi: 10.1155/2021/5591559. eCollection 2021.'}, {'pmid': '29319463', 'type': 'BACKGROUND', 'citation': 'Rennebohm RM, Asdaghi N, Srivastava S, Gertner E. Guidelines for treatment of Susac syndrome - An update. Int J Stroke. 2020 Jul;15(5):484-494. doi: 10.1177/1747493017751737. Epub 2018 Jan 10.'}, {'pmid': '32045006', 'type': 'BACKGROUND', 'citation': 'Sveinsson O, Kolloch J, Traisk F, Brundin L. [Susac syndrome - an unusual syndrome which can be mistaken for multiple sclerosis]. Lakartidningen. 2020 Feb 10;117:FSSS. Swedish.'}, {'pmid': '32878610', 'type': 'BACKGROUND', 'citation': 'Wilf-Yarkoni A, Elkayam O, Aizenstein O, Oron Y, Furer V, Zur D, Goldstein M, Barequet D, Hallevi H, Karni A, Habot-Wilner Z, Regev K. Increased incidence of Susac syndrome: a case series study. BMC Neurol. 2020 Sep 2;20(1):332. doi: 10.1186/s12883-020-01892-0.'}], 'seeAlsoLinks': [{'url': 'https://clinmedjournals.org/articles/cmrcr/clinical-medical-reviews-and-case-reports-cmrcr-9-396.php?jid=cmrcr', 'label': 'Susac Syndrome: Collaboration is Required for a Diagnosis'}, {'url': 'https://www.physio-pedia.com/Timed_Up_and_Go_Test_(TUG)', 'label': 'Physiopedia contributors. (2022). Timed Up and Go Test (TUG). Physiopedia.'}, {'url': 'https://www.physio-pedia.com/Benefits_of_Rehabilitation', 'label': 'Physiopedia contributors. (2023). Benefits of Rehabilitation. Physiopedia.'}, {'url': 'https://www.physio-pedia.com/Assessing_Range_of_Motion', 'label': 'Physiopedia contributors. (2024a). Assessing Range of Motion. Physiopedia.'}, {'url': 'https://www.physio-pedia.com/Muscle_Strength_Testing', 'label': 'Physiopedia contributors. (2024b). Muscle Strength Testing. Physiopedia'}, {'url': 'https://wjarr.com/sites/default/files/WJARR-2023-0294.pdf', 'label': 'A case of possible Susac syndrome with avascular necrosis of hip'}]}, 'descriptionModule': {'briefSummary': "Susac's syndrome is a rare autoimmune disorder characterised by a triad of encephalopathy (brain dysfunction), branch retinal artery occlusion (loss of vision) and sensorineural hearing loss. This study presents the case of a patient undergoing intensive physiotherapy intervention following an injury, focusing on assessments such as volume and range of motion measurements, manual muscle tests, and pain intensity evaluations using various scales.", 'detailedDescription': 'The patient, aged 17, initially presented with severe limitations in mobility, diagnosed with Susac syndrome. Requiring assistance to walk even short distances due to fear and insecurity. Through a structured physiotherapy program spanning several months, various assessments were conducted, including manual muscle tests and circumference measurements. Significant improvements were observed for muscle function, upper and lower limb circumferences, and performance in mobility tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consisted of a single adolescent patient diagnosed with Susac syndrome, aged 17 years. The patient presented with motor impairments and functional limitations attributed to Susac syndrome, including difficulties in mobility and muscle weakness. No significant comorbidities were reported, and the patient was medically stable to participate in a 12-week intensive physiotherapy program. Informed consent was obtained from the participant and their legal guardian prior to enrollment in the study."', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of Susac syndrome.\n* Willingness and ability to participate in a 12-week intensive physiotherapy program.\n* Stable medical condition that allows participation in physiotherapy without significant risks.\n* Ability to provide informed consent for participation in the study.\n\nExclusion Criteria:\n\n* Presence of severe comorbidities or medical conditions that would interfere with participation in physiotherapy or confound the study outcomes.\n* Inability to comprehend or follow the instructions for physiotherapy exercises.\n* Pregnancy, as certain physiotherapy modalities may not be suitable during pregnancy.\n* Any other condition or circumstance that, in the opinion of the investigator, would compromise the safety or validity of participation in the study.'}, 'identificationModule': {'nctId': 'NCT06349603', 'briefTitle': 'Physiotherapy Approach for Susac Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Rehabilitation Centre Zivot'}, 'officialTitle': 'Integrated Physiotherapy Approach for Susac Syndrome: A Comprehensive Case Study', 'orgStudyIdInfo': {'id': 'S2023'}}, 'contactsLocationsModule': {'locations': [{'zip': '88000', 'city': 'Mostar', 'country': 'Bosnia and Herzegovina', 'facility': 'Rehabilitation centre Život', 'geoPoint': {'lat': 43.34333, 'lon': 17.80806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rehabilitation Centre Zivot', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Darko Bilic', 'investigatorAffiliation': 'Rehabilitation Centre Zivot'}}}}