Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-29 @ 8:42 PM
Study NCT ID:
NCT06904768
Status:
RECRUITING
Last Update Posted:
2025-04-01
First Post:
2025-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Shoulder Sling Use on Balance and Mobility in Subacute Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006429', 'term': 'Hemiplegia'}, {'id': 'D051346', 'term': 'Mobility Limitation'}, {'id': 'D020521', 'term': 'Stroke'}], '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'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 17}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-29', 'studyFirstSubmitDate': '2025-03-23', 'studyFirstSubmitQcDate': '2025-03-29', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Timed Up and Go (TUG) Test', 'timeFrame': 'Within 1 day (each participant performs it twice - with and without sling)', 'description': 'Time required (in seconds) to stand up from a chair, walk 3 meters, turn, walk back, and sit down.'}, {'measure': 'Functional Reach Test (FRT)', 'timeFrame': 'Within 1 day (each participant performs it twice - with and without sling)', 'description': 'Distance reached (in centimeters) while standing and reaching forward without losing balance.'}, {'measure': 'Modified Four Square Step Test (mFSST)', 'timeFrame': 'Within 1 day (each participant performs it twice - with and without sling)', 'description': 'Time required to step in all four quadrants in a specified sequence.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Hemiplegia', 'mobility', 'dynamic balance', 'balance', 'shoulder brace', 'arm sling'], 'conditions': ['Hemiplegia', 'Balance Disorders', 'Mobility Limitation', 'Shoulder Subluxation', 'Stroke']}, 'descriptionModule': {'briefSummary': 'This study examines whether wearing a shoulder sling can improve balance and mobility in people who are recovering from a stroke. Participants will perform simple movement and balance tests twice-once with the sling and once without. The goal is to find out if using the sling helps patients feel more stable and safe during walking and everyday activities.', 'detailedDescription': 'This is a cross-over study designed to evaluate the impact of shoulder sling use on balance and functional mobility in patients recovering from stroke in the subacute phase. Participants will be asked to complete three validated functional tests: the Timed Up and Go (TUG) test, the Functional Reach Test (FRT), and the Modified Four Square Step Test (mFSST). Each test will be performed twice, once with the shoulder sling and once without, in randomized order. The study aims to determine whether the sling provides measurable benefits in stability and performance during movement tasks. Data will be collected in rehabilitation centers under the supervision of clinical researchers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of stroke in the subacute phase (up to 6 months post-onset)\n* Hemiplegia affecting one upper limb\n* Brunnstrom stage \\< 4 for the affected upper limb\n* Functional Ambulation Category (FAC) score \\> 3\n* Age between 40 and 80 years\n* Ability to follow simple instructions\n* Medically stable to participate in balance and mobility testing\n* Signed informed consent\n\nExclusion Criteria:\n\n* Severe cognitive impairment (e.g. MMSE \\< 23)\n* Visual or vestibular disorders affecting balance\n* Significant orthopedic or musculoskeletal conditions of the lower limbs\n* Uncontrolled cardiovascular or pulmonary disease\n* Use of assistive devices that prevent sling application\n* Severe aphasia interfering with understanding or communication\n* Skin lesions or injuries at the shoulder region preventing sling use'}, 'identificationModule': {'nctId': 'NCT06904768', 'acronym': 'SLS-Stroke', 'briefTitle': 'Effect of Shoulder Sling Use on Balance and Mobility in Subacute Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of West Attica'}, 'officialTitle': 'A Cross-Over Study on the Effect of Shoulder Sling Use on Balance and Functional Mobility in Patients With Hemiplegia During the Subacute Phase of Stroke Rehabilitation', 'orgStudyIdInfo': {'id': 'SLS2025-GR01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Shoulder Sling', 'description': 'Participants perform balance and mobility tests (TUG, FRT, mFSST) while wearing a shoulder sling on the affected upper limb.', 'interventionNames': ['Device: Shoulder Sling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No Sling', 'description': 'The same functional tests are performed without the use of a shoulder sling.', 'interventionNames': ['Other: No Sling']}], 'interventions': [{'name': 'Shoulder Sling', 'type': 'DEVICE', 'description': 'Use of a shoulder sling (Reh4mat AM-SOB) on the affected upper limb during mobility and balance testing.', 'armGroupLabels': ['Shoulder Sling']}, {'name': 'No Sling', 'type': 'OTHER', 'description': 'Functional mobility tests performed without the use of any assistive shoulder device.', 'armGroupLabels': ['No Sling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19441', 'city': 'Koropí', 'state': 'Attica', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Eythimia Vagena', 'role': 'CONTACT', 'email': 'e.vagena@filorehab.gr', 'phone': '6948467145'}, {'name': 'Stylianos Arnaoytis', 'role': 'CONTACT', 'email': 'mscphys23001@uniwa.gr', 'phone': '6981199528'}, {'name': 'Efthimia Vagena', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Filoktitis Recovery and Rehabilitation Center', 'geoPoint': {'lat': 37.89886, 'lon': 23.87181}}], 'centralContacts': [{'name': 'Stylianos Arnaoutis', 'role': 'CONTACT', 'email': 'mscphys23001@uniwa.gr', 'phone': '+306981199528'}, {'name': 'Stylianos Arnaoutis', 'role': 'CONTACT', 'email': 'mscphys23001@uniwa.gr', 'phone': '6981199528'}], 'overallOfficials': [{'name': 'Nikolaos Chrysagis', 'role': 'STUDY_CHAIR', 'affiliation': 'University of West Attica'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arnaoutis Stylianos', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of West Attica', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Arnaoutis Stylianos', 'investigatorAffiliation': 'University of West Attica'}}}}