Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-02 @ 3:20 PM
Study NCT ID:
NCT04171856
Status:
RECRUITING
Last Update Posted:
2025-04-03
First Post:
2019-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring Motor Learning in Acute Stroke Through Robotics
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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 245}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2040-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2019-11-12', 'studyFirstSubmitQcDate': '2019-11-18', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in SAT (CIRCUIT)', 'timeFrame': 'change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)', 'description': 'Speed/ Accuracy Trade-off'}, {'measure': 'total distance travelled (EASY)', 'timeFrame': 'change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)', 'description': 'total distance travelled between the walls of the brick busters (in cm)'}], 'secondaryOutcomes': [{'measure': 'Fugl Meyer Upper Extremity Test', 'timeFrame': 'change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)', 'description': 'Tests impairments of the upper limb after stroke'}, {'measure': 'Arm Motor Ability (AMA) test', 'timeFrame': 'change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)', 'description': 'Measure disabilities of the upper limb after stroke'}, {'measure': 'Fatigue Visual Analog Scale (VAS)', 'timeFrame': 'change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)', 'description': 'Visual Analog Scale to evaluate fatigue between 0 and 10. The maximum value (10) indicate a high level of fatiguability.'}, {'measure': 'Voxel-based Lesion Symptom Mapping (VLSM)', 'timeFrame': 'Baseline', 'description': 'High-resolution 3D-MRI, diffusion MRI (DWI) \\& perfusion MRI (PWI with Arterial SPin Labelling technique) will be acquired. The stroke areas will be drawn with MRIcron as volumes of interest (VOI) in native space and compared.'}, {'measure': 'Dextrain®', 'timeFrame': 'change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)', 'description': 'Quantitative assessment of the manual dexterity : fingers strength and selectivity, coactivation.'}, {'measure': 'Grober and Buschke test (16 items) (for patients with trasient global amnesia)', 'timeFrame': 'Baseline', 'description': 'Assessement of episodic verbal memory'}, {'measure': 'Brief Visuospatial Memory Test-Revised', 'timeFrame': 'Baseline', 'description': 'Measure of visuospatial memory (for patients with trasient global amnesia)'}, {'measure': 'Forces of the upper limb on the REAplan robot (CIRCUIT, EASY, REACHING)', 'timeFrame': 'change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)', 'description': 'To evaluate the Force of the upper limb after stroke (Newton)'}, {'measure': 'Spectral Arc Lenght on the REAplan robot (CIRCUIT, EASY, REACHING)', 'timeFrame': 'change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)', 'description': 'Movement smoothness quantification'}, {'measure': 'Total distance of the upper limb on the REAplan robot (CIRCUIT, EASY, REACHING)', 'timeFrame': 'change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)', 'description': 'Measure of total distance traveled during the training (cm)'}, {'measure': 'transcranial magnetic stimulation (TMS)', 'timeFrame': 'correlation with the measure realized Day 1 with progression of the motor skill learning (change between Baseline Day1 and Day 3)', 'description': 'Measure of the prediction recovery after stroke'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute stroke', 'Motor skill learning', 'Upper limb', 'Rehabilitation', 'Subacute stroke'], 'conditions': ['Stroke, Acute']}, 'descriptionModule': {'briefSummary': 'The acute phase of stroke is characterized by an enhancement of neural plasticity which supports rapid motor recovery. It is unclear whether acute stroke patients can acquire new motor skills with their affected upper limb. The aims of this research program are:\n\n1. To test the capacity of acute stroke patients (\\< 21 days) to learn and retain a complex unimanual motor skill.\n2. To explore whether acute stroke to different brain regions (quantified with brain MRI) induces specific deficits in motor skill learning.\n3. To compare acute stroke patients with healthy individuals and with chronic stroke patients.', 'detailedDescription': 'Over 3 consecutive days, the subjects will be evaluated and will train on the rehabilitation robot REAplan® (http://www.axinesis.com/). They will practice 2 serious games on the robot.\n\nIn order to differentiate the effect of motor control recovery from that of MskL, the acute stroke patients will be randomised 4/1 to "MskL" (n=120) ,to "motor control recovery" (n=30) or to "conventional" group (n=15) with a minimisation software. The experimental design will be similar except that the "motor control recovery" group will practice the serious game EASY instead of CIRCUIT (see below) and the "conventional" group will practice conventional therapy instead of CIRCUIT. The performances on both EASY \\& CIRCUIT will be compared between groups (subjects in both groups will perform the EASY \\& CIRCUIT tasks).The total time of rehabilitation will be the same.\n\nThe motor skill learning setup (CIRCUIT + EASY) that we developed and successfully used in healthy individuals and stroke patients has already been implemented in the REAplan environment and will be used as innovative serious games based on a speed/accuracy trade-off (SAT), allowing a detailed analysis of motor skill learning components (speed, accuracy, SAT, movement smoothness, dynamics...). For the serious game CIRCUIT, who based on motor skill learning, the subjects will have to practice a complex circuit and move as a cursor quickly and accurately as possible by controlling the handle of the robot with their affected hand/arm. For the other task EASY (a brick busters serious game), the aim will be to go back and forth between walls presented in different locations. The CONVENTIONAL therapy will consist in classical exercices focused in the upper limb administered by occupational therapist.\n\nThe subacute stroke phase is a unique opportunity to investigate the role of brain structures in motor learning/control. Compared to chronic impairments (\\> 6 months post-stroke), the subacute phase provides a window into how a lesion perturbs sensorimotor functions prior to reorganisation driven by plasticity and neurorehabilitation. To clarify the role of different brain structures in MskL, Voxel-based Lesion Symptom Mapping (VLSM) based on high-resolution brain magnetic resonance imaging (MRI) scans, will be used to analyse the relationship between tissue damage and MskL scores on a voxel-by-voxel basis.\n\nIn addition, several "classical" clinical scales and tests will be used to evaluate overall motor-sensory-cognitive functions. The subjects will practice serious games on the robot REAplan (R), requiring movements with the affected arm (unimanual tasks).\n\nAnd, we used a Dextrain® tool which allows quantification of key components of manual dexterity : forces, selectivity (independance of fingers movement) and coactivation of the fingers.Moreover, we added a Transcranial magnetic stimulation (TMS), as a tool for predicting recovery of motor function after stroke.\n\nIn addition to the (sub)acute stroke patients, 4 others groups will be recruited for this study : a group of acute stroke patients who will receive "conventional rehabilitation" and be shortly tested on the robot (N=15), a group of chronic stroke patients (stroke \\> 6 months) who will not be hospitalized and will not undergo MRI (N=30), a group of healthy individuals who will not undergo MRI (N=50) and a group of patients with a transient global amnesia which is a sudden, temporary episode (\\<24hours) of memory loss (N=15).\n\nSubjects in these 4 groups will be randomized 1/1 in the two arms ("MSkL" versus "motor control recovery" arms), except the patients with a TGA who will be included in the "MSkL" arm only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'ACUTE STROKE PATIENTS:\n\nInclusion Criteria:\n\n* acute stroke (\\> 21 days)\n* aged 18-90 years\n* with a stroke lesion on brain imaging\n\nExclusion Criteria:\n\n* " classical " contre-indication to MRI (non-MR-compatible pacemaker, pregnancy, non-MR-compatible implanted devices, claustrophoby, etc ...)\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\nPATIENTS WITH TRANSIENT GLOBAL AMNESIA:\n\nClinical diagnosis, criteria of Hodge \\& Warlow (1990):\n\n* Anterograde amnesia observed by a witness\n* No alteration of consciousness or loss of identity\n* Cognitive dysfunction limited to amnesia\n* Lack of focused neurological deficit or argument for a comitiality\n* Absence of head trauma\n* Symptom resolution within 24 hours\n* Possible existence of vegetative symptoms\n\nInclusion criteria:\n\n* Transient global amnesia\n* 8-90 years old\n* Be able to perform 3 consecutive sessions on a rehabilitation robot\n\nExclusion criteria:\n\n* Severe aphasia / cognitive deficits interfering with study\n* Psychiatric disorders\n* Alcohol / drug addiction\n* Exclusion criteria related to MRI\n\nHEALTHY INDIVIDUALS:\n\nInclusion Criteria:\n\n• 18-90 years\n\nExclusion Criteria:\n\n* medical history with a previous stroke/neurological deficit\n* drug/alcohol abuse\n* psychiatric condition/ dementia\n\nCHRONIC STROKE PATIENTS:\n\nInclusion Criteria:\n\n* chronic stroke (\\>6 months)\n* aged 18-90 years\n* with 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'}, 'identificationModule': {'nctId': 'NCT04171856', 'briefTitle': 'Exploring Motor Learning in Acute Stroke Through Robotics', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Mont-Godinne'}, 'officialTitle': 'Exploring Motor Learning in Acute Stroke Through Robotics', 'orgStudyIdInfo': {'id': 'B039201938990'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motor Skill Learning (CIRCUIT)', 'description': 'Intervention: training on the REAplan robot with a serious game based on motor skill learning (MSkL) serious game, the CIRCUIT.', 'interventionNames': ['Device: REAplan(R)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Motor control recovery (EASY)', 'description': 'Training on the REAplan robot with a serious game that requires similar type and amount of movements but does not rely on motor skill learning (EASY), a brick buster game.', 'interventionNames': ['Device: REAplan(R)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional', 'description': 'Training sessions with classical exercices focused on the upper limb administered by occupation therapist.', 'interventionNames': ['Device: REAplan(R)']}], 'interventions': [{'name': 'REAplan(R)', 'type': 'DEVICE', 'description': 'motor skill learning with the REAplan(R) rehabilitation robot, to be perfomed with the affected arm', 'armGroupLabels': ['Conventional', 'Motor Skill Learning (CIRCUIT)', 'Motor control recovery (EASY)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5530', 'city': 'Yvoir', 'state': 'Namur', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Eloïse Gerardin', 'role': 'CONTACT', 'email': 'eloise.gerardin@uclouvain.be', 'phone': '+3281423348'}], 'facility': 'CHU UCL Namur', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'zip': '5530', 'city': 'Yvoir', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Yves Vandermeeren, MD, PhD', 'role': 'CONTACT', 'email': 'yves.vandermeeren@uclouvain.be'}], 'facility': 'University Hospital CHU Dinant Godinne UCL', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}], 'centralContacts': [{'name': 'Yves Vandermeeren, MD, PhD', 'role': 'CONTACT', 'email': 'yves.vandermeeren@uclouvain.be', 'phone': '+32 81 42 33 21'}, {'name': 'Eloïse Gerardin, MSc', 'role': 'CONTACT', 'email': 'eloise.gerardin@uclouvain.be', 'phone': '+32 81 42 33 48'}], 'overallOfficials': [{'name': 'Yves Vandermeeren, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCLouvain IONS'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'The data will become available during thebeggining of the study and for 20 years.', 'ipdSharing': 'YES', 'description': 'the precise IPD plan has to be worked out if an easy and user-friendly solution is available, we intend to make the data available (after anonymisation of personal data).', 'accessCriteria': 'Login user of the Hospital of CHU UCL Namur -Site Godinne'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Mont-Godinne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pr Yves Vandermeeren, MD, PhD', 'investigatorAffiliation': 'University Hospital of Mont-Godinne'}}}}