Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-27 @ 11:04 PM
Study NCT ID:
NCT05152433
Status:
RECRUITING
Last Update Posted:
2023-12-08
First Post:
2021-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evidence-Based Robot-Assistant in Neurorehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D010291', 'term': 'Paresis'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2021-11-07', 'studyFirstSubmitQcDate': '2021-12-07', 'lastUpdatePostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Type and frequency of neurorehabilitation therapy received', 'timeFrame': '2 weeks', 'description': 'Therapy documentation for the period of two weeks'}], 'primaryOutcomes': [{'measure': 'Change scores over two weeks for the standardised primary outcome measure', 'timeFrame': '2 weeks', 'description': 'Change scores are difference scores for assessments taken two weeks apart. Changes scores are based on standardised outcome measures. Assessment scores for each measure (see below) are standardised using the known variance in stroke survivor populations for the respective measure.\n\nThe following assessments will be used for standardised outcome measures:\n\nNine-Hole-Peg-Test, NHPT (finger dexterity) and Box-and-Block Test, BBT (gross manual dexterity) (for participants with mild arm paresis); Fugl Meyer, Arm motor score, FM Arm (selective arm and hand movement capacity) (participants with moderate to severe arm paresis); Neglect-Test, NET (spatial visual attention) (participants with visual neglect).'}], 'secondaryOutcomes': [{'measure': 'Drop-out rate', 'timeFrame': '2 weeks', 'description': 'Drop-outs'}, {'measure': 'Goal attainment', 'timeFrame': '2 weeks', 'description': 'Goal attainment Scale (GAS)'}, {'measure': 'Change scores over two weeks for "Motivation for therapy"', 'timeFrame': '2 weeks', 'description': 'Change scores are difference scores for assessments taken two weeks apart with Visual Analogue Scales (VAS) for motivational factors (Min 0, Max 100)'}, {'measure': 'Change scores over two weeks for "Emotional distress"', 'timeFrame': '2 weeks', 'description': 'Change scores are difference scores for assessments taken two weeks apart with the Hospital Anxiety and Depression Scale (HADS)'}, {'measure': 'Work alliance', 'timeFrame': '2 weeks', 'description': 'Assessment of the perceived work alliance for the period of two weeks prior using the Work Alliance Inventory (WAI)'}, {'measure': 'Adverse events', 'timeFrame': '2 weeks', 'description': 'Adverse events documentation for the period of two weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Paresis', 'Neglect, Hemispatial']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ebrain-science.de/en/home/', 'label': 'Research web site'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the efficacy, acceptability, and safety of the therapeutic system E-BRAiN for the treatment of stroke-related impairments.', 'detailedDescription': 'This randomized controlled trial, RCT with cross-over design sequentially allocates participants with stroke-related impairment to both a two week course of conventional rehabilitation therapy and a two week course of therapy using the therapy system E-BRAiN (purpose-built therapy system using a socially interactive humanoid robot); participants are randomly allocated to the sequences "conventional =\\> robot" or "robot =\\> conventional". Stroke survivors with one of the target syndromes, i.e. mild arm paresis, or moderate to severe arm paresis, or visuospatial neglect are invited to participate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age at study entry ≥ 18 years\n* Stroke (ischemic stroke, non-traumatic intracerebral haemorrhage, subarachnoidal haemorrhage)\n* Incomplete arm paresis (Motricity Index, arm score \\>1 \\[Min\\] and \\< 100 \\[Max\\]) or\n* Visuospatial neglect (clinical signs and NET subtest "star cancellation" score \\< 50)\n* Candidate able to consent and provides informed consent or\n* legal representative provides informed consent\n\nExclusion Criteria:\n\n* Pregnant or breast feeding\n* Obliged to live in an institution by law or public authority\n* With case presentation arm paresis: another condition that causes arm paresis is present\n* With case presentation visuospatial neglect: another condition that causes a relevant visual-perceptual deficit that cannot be compensated is present; exception: homonymous visual field deficits are not an exclusion criterion'}, 'identificationModule': {'nctId': 'NCT05152433', 'acronym': 'E-BRAiN', 'briefTitle': 'Evidence-Based Robot-Assistant in Neurorehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'University Medicine Greifswald'}, 'officialTitle': 'E-BRAiN - Evidence-Based Robot-Assistant in Neurorehabilitation', 'orgStudyIdInfo': {'id': '202101E-BRAiN'}, 'secondaryIdInfos': [{'id': 'CIV-21-01-035629', 'type': 'REGISTRY', 'domain': 'EUDAMED'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional therapy', 'description': 'Length of period: 2 weeks', 'interventionNames': ['Behavioral: Conventional therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Therapy assisted by a humanoid robot (E-BRAiN)', 'description': 'Length of period: 2 weeks Fixed dose: 10 therapy sessions with E-BRAiN', 'interventionNames': ['Device: E-BRAiN therapy']}], 'interventions': [{'name': 'E-BRAiN therapy', 'type': 'DEVICE', 'description': 'The therapy system E-BRAiN is a purpose-built therapy system using a socially interactive humanoid robot and provides individualised therapy for arm rehabilitation based on the evidence-based therapies arm basis training, arm ability training, or mirror therapy for arm rehabilitation (paresis) or neurovisual training (neglect).', 'armGroupLabels': ['Therapy assisted by a humanoid robot (E-BRAiN)']}, {'name': 'Conventional therapy', 'type': 'BEHAVIORAL', 'description': 'Conventional therapy specifies the neurorehabilitation therapy as applied as regular treatment.', 'armGroupLabels': ['Conventional therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17475', 'city': 'Greifswald', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Thomas Platz, Prof.Dr.med.', 'role': 'CONTACT', 'email': 'thomas.platz@uni-greifswald.de', 'phone': '+49-3834 871', 'phoneExt': '490'}, {'name': 'Ann Loiuse Pedersen, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Universitätsmedizin Greifswald', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}, {'zip': '17491', 'city': 'Greifswald', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Thomas Platz, Prof.Dr.med.', 'role': 'CONTACT', 'email': 't.platz@bdh-klinik-greifswald.de', 'phone': '+49-3835-871', 'phoneExt': '490'}, {'name': 'Ann Louise Pedersen', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'BDH-Klinik Greifswald', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}], 'centralContacts': [{'name': 'Stefan Engeli, Prof.Dr.', 'role': 'CONTACT', 'email': 'stefan.engeli@med.uni-greifswald.de', 'phone': '+49-3834-86', 'phoneExt': '5633'}, {'name': 'Franziska Schuster, Dr.rer.nat.', 'role': 'CONTACT', 'email': 'franziska.schuster@med.uni-greifswald.de', 'phone': '+49-3834 86', 'phoneExt': '7420'}], 'overallOfficials': [{'name': 'Thomas Platz, Prof.Dr.med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head, Neurorehabilitation Research Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medicine Greifswald', 'class': 'OTHER'}, 'collaborators': [{'name': 'BDH-Klinik Greifswald', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}