Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-25 @ 2:40 PM
Study NCT ID:
NCT03974750
Status:
RECRUITING
Last Update Posted:
2025-04-03
First Post:
2019-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bimanual Motor Skill Learning Through Robotics in Stroke Survivors and Healthy Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Evaluation of bimanual motor skill learning Motor skill learning with a rehabilitation robot'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2019-05-28', 'studyFirstSubmitQcDate': '2019-06-03', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bi-SAT, bimanual Speed/Accurady Trade-off measured by the REAplan robot', 'timeFrame': 'change between baseline (Day 1) and after training (Day 3)', 'description': 'bimanual Speed/Accurady Trade-off: mathematical computation of the relationship bewteen speed and accuracy'}, {'measure': 'bi-CO, bimanual Coordination factor measured by the REAplan robot', 'timeFrame': 'change between baseline (Day 1) and after training (Day 3)', 'description': 'bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both arms'}, {'measure': 'bi-Force, bimanual Coordination factor measured by the REAplan robot', 'timeFrame': 'change between baseline (Day 1) and after training (Day 3)', 'description': 'bimanual forces, forces exerted in the wrong direction by each arm (Newtons)'}], 'secondaryOutcomes': [{'measure': 'bi-SAT on bimanual REACHING (REAplan robot)', 'timeFrame': 'change between baseline (Day 1) and after training (Day 3)', 'description': 'bimanual Speed/Accurady Trade-off: mathematical computation of the relationship'}, {'measure': 'bi-Force on bimanual REACHING (REAplan robot)', 'timeFrame': 'change between baseline (Day 1) and after training (Day 3)', 'description': 'bimanual forces, forces exerted in the wrong direction by each arm (Newtons)'}, {'measure': 'bi-CO on bimanual REACHING (REAplan robot)', 'timeFrame': 'change between baseline (Day 1) and after training (Day 3)', 'description': 'bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both arms'}, {'measure': 'bi-smoothness on bimanual REACHING (REAplan robot)', 'timeFrame': 'change between baseline (Day 1) and after training (Day 3)', 'description': 'Smoothness of movement : Spectral Arc Length (SPARC)'}, {'measure': 'bi-error on bimanual REACHING (REAplan robot)', 'timeFrame': 'change between baseline (Day 1) and after training (Day 3)', 'description': 'Error in centimeres or degrees during bimanual reaching'}, {'measure': 'BBT', 'timeFrame': 'change between baseline (Day 1) and after training (Day 3)', 'description': 'Box \\& Blocks Test (timed transfert of blocks from one space to the other, 3 trials/hand)'}, {'measure': 'whole-hand GF', 'timeFrame': 'change between baseline (Day 1) and after training (Day 3)', 'description': 'whole-hand Grip Force (GF) measured with a dynamometer, 3 trials/hand)'}, {'measure': 'Visual Analog Scale for fatigue (VAS fatigue)', 'timeFrame': 'change between baseline (Day 1) and after training (Day 3)', 'description': 'Visual Analog Scale to evaluate fatigue = a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. Range : 0- 10.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '29326573', 'type': 'BACKGROUND', 'citation': 'Yeganeh Doost M, Orban de Xivry JJ, Bihin B, Vandermeeren Y. Two Processes in Early Bimanual Motor Skill Learning. Front Hum Neurosci. 2017 Dec 20;11:618. doi: 10.3389/fnhum.2017.00618. eCollection 2017.'}, {'pmid': '31088342', 'type': 'BACKGROUND', 'citation': 'Doost MY, Orban de Xivry JJ, Herman B, Vanthournhout L, Riga A, Bihin B, Jamart J, Laloux P, Raymackers JM, Vandermeeren Y. Learning a Bimanual Cooperative Skill in Chronic Stroke Under Noninvasive Brain Stimulation: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2019 Jun;33(6):486-498. doi: 10.1177/1545968319847963. Epub 2019 May 15.'}, {'pmid': '29420360', 'type': 'BACKGROUND', 'citation': 'Dehem S, Gilliaux M, Lejeune T, Delaunois E, Mbonda P, Vandermeeren Y, Detrembleur C, Stoquart G. Effectiveness of a single session of dual-transcranial direct current stimulation in combination with upper limb robotic-assisted rehabilitation in chronic stroke patients: a randomized, double-blind, cross-over study. Int J Rehabil Res. 2018 Jun;41(2):138-145. doi: 10.1097/MRR.0000000000000274.'}, {'pmid': '35300709', 'type': 'DERIVED', 'citation': 'Gerardin E, Bontemps D, Babuin NT, Herman B, Denis A, Bihin B, Regnier M, Leeuwerck M, Deltombe T, Riga A, Vandermeeren Y. Bimanual motor skill learning with robotics in chronic stroke: comparison between minimally impaired and moderately impaired patients, and healthy individuals. J Neuroeng Rehabil. 2022 Mar 17;19(1):28. doi: 10.1186/s12984-022-01009-3.'}, {'pmid': '33433485', 'type': 'DERIVED', 'citation': 'Yeganeh Doost M, Herman B, Denis A, Sapin J, Galinski D, Riga A, Laloux P, Bihin B, Vandermeeren Y. Bimanual motor skill learning and robotic assistance for chronic hemiparetic stroke: a randomized controlled trial. Neural Regen Res. 2021 Aug;16(8):1566-1573. doi: 10.4103/1673-5374.301030.'}]}, 'descriptionModule': {'briefSummary': 'To test the capacity of healthy and chronic stroke patients to learn and retain a complex bimanual motor skill, trained on the neurorehabilitation robot REAplan (R) (bimanual version).', 'detailedDescription': 'Over 3 consecutive days, healthy individuals and chronic stroke patients (1) will be evaluated and (2) will train on the neurorehabilitation robot REAplan(R).\n\nThey will practice several tasks on the robot REAplan (R) (bimanual version), requiring either movements with the affected arm (unimanual tasks) and complex, coordinated movements with both arms (bimanual tasks).\n\nIn addition, several "classical" clinical scales and tests will be used to evaluate overall motor-sensory-cognitive functions (clinical tests, questionnaires, ...).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'STROKE PATIENTS :\n\nInclusion Criteria:\n\n* having a chronic stroke (\\>6 months)\n* aged 18-90 years\n* with demonstrate a stroke lesion on brain imaging.\n\nExclusion Criteria:\n\n* difficulty in understanding or executing commands\n* drug/alcohol abuse\n* severe aphasia / cognitive deficits interfering with study\n* inability to voluntarily move the affected arm (i.e. complete paralysis of the arm)\n* multiple strokes / dementia / psychiatric condition\n* botulinum toxin injections (to be evaluated)\n\nHEALTHY INDIVIDUALS :\n\nInclusion Criteria:\n\n\\- 18-90 years\n\nExclusion Criteria:\n\n* neurological conditions interfering with the study\n* drug/alcohol abuse\n* pyschiatric condition'}, 'identificationModule': {'nctId': 'NCT03974750', 'acronym': 'bimMsKL', 'briefTitle': 'Bimanual Motor Skill Learning Through Robotics in Stroke Survivors and Healthy Individuals', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Mont-Godinne'}, 'officialTitle': 'Bimanual Motor Skill Learning Through Robotics in Stroke Survivors and Healthy Individuals', 'orgStudyIdInfo': {'id': 'bimMsKL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'Training on the rehabilitation robot REAplan(R) to learn complex, coordinated bimanual movements', 'interventionNames': ['Device: Bimanual motor skill learning with the REAplan(R) rehabilitation robot']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control intervention', 'description': 'Training on the rehabilitation robot REAplan(R) with simple movements', 'interventionNames': ['Device: Bimanual motor skill learning with the REAplan(R) rehabilitation robot']}], 'interventions': [{'name': 'Bimanual motor skill learning with the REAplan(R) rehabilitation robot', 'type': 'DEVICE', 'description': 'REAplan(R) rehabilitation robot : training to perform complex, coordinated, bimanual movements', 'armGroupLabels': ['control intervention', 'intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5530', 'city': 'Yvoir', 'state': 'Namur', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Yves Vandermeeren, MD, PhD', 'role': 'CONTACT', 'email': 'yves.vandermeeren@uclouvain.be', 'phone': '+32 81 42 3321'}, {'name': 'Mie Leeuwerck, PT', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Audrey Riga, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Damien Bontemps, student', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nicolas-Thomas Babuin, student', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU UCL Namur, Mont-Godinne, Neurology Department, Stroke Unit', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'city': 'Yvoir', 'state': 'Namur', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Yves Vandermeeren, MD,PhD', 'role': 'CONTACT', 'email': 'yves.vandermeeren@uclouvain.be', 'phone': '081 42 3321', 'phoneExt': '+32'}], 'facility': 'Department of Neurology, CHU Mont-Godinne', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}], 'centralContacts': [{'name': 'Yves Vandermeeren, MD, PhD', 'role': 'CONTACT', 'email': 'yves.vandermeeren@uclouvain.be', 'phone': '+3281423321'}], 'overallOfficials': [{'name': 'Yves Y Vandermeeren, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université catholique de Louvain, Institute of NeuroScience (IONS) NEUR / CHU'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Up to 2 years after publication of the scientific articles', 'ipdSharing': 'YES', 'description': 'the precise IPD plan has to be worked out in order to find the best public repository', 'accessCriteria': 'none (public)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Mont-Godinne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Université Catholique de Louvain', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Neurologist, Principal Investigator, Clinical Professor', 'investigatorFullName': 'Pr Yves Vandermeeren, MD, PhD', 'investigatorAffiliation': 'University Hospital of Mont-Godinne'}}}}