Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-03-28 @ 3:25 PM
Study NCT ID:
NCT02860403
Status:
COMPLETED
Last Update Posted:
2019-05-28
First Post:
2016-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motor Imagery for Reach-to-grasp Rehabilitation After Tetraplegia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-23', 'studyFirstSubmitDate': '2016-08-04', 'studyFirstSubmitQcDate': '2016-08-08', 'lastUpdatePostDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor imagery ability', 'timeFrame': '10 weeks', 'description': 'Motor imagery ability assessed by magnetoencephalography measurements'}], 'secondaryOutcomes': [{'measure': 'Movement time (MT)', 'timeFrame': '10 weeks', 'description': 'Kinematic parameters of movement: temporal parameters: movement time (MT)'}, {'measure': 'absolute time to peak velocity', 'timeFrame': '10 weeks', 'description': 'Kinematic parameters of movement: temporal parameters: absolute time to peak velocity'}, {'measure': 'movement amplitude at peak velocity', 'timeFrame': '10 weeks', 'description': 'Kinematic parameters of movement: temporal parameters: movement amplitude at peak velocity'}, {'measure': 'time to opening', 'timeFrame': '10 weeks', 'description': 'Kinematic parameters of movement: temporal parameters: time to opening'}, {'measure': 'time to maximal opening', 'timeFrame': '10 weeks', 'description': 'Kinematic parameters of movement: temporal parameters: time to maximal opening'}, {'measure': 'amplitude of maximal opening', 'timeFrame': '10 weeks', 'description': 'Kinematic parameters of movement: temporal parameters: amplitude of maximal opening'}, {'measure': 'Trajectory of movement measured in the XY plane', 'timeFrame': '10 weeks', 'description': 'Kinematic parameters of movement: spatial parameters: Trajectory of movement measured in the XY plane'}, {'measure': 'height of elbow and wrist at the moment of grasping an object, measured in mm in the YZ plane', 'timeFrame': '10 weeks', 'description': 'Kinematic parameters of movement: spatial parameters: height of elbow and wrist at the moment of grasping an object, measured in mm in the YZ plane'}, {'measure': 'muscular force evaluated by muscle testing performed by a physiotherapist', 'timeFrame': '10 weeks', 'description': 'muscular force evaluated by muscle testing performed by a physiotherapist (score from 0 to 5)'}, {'measure': 'joint amplitude evaluated in degrees (°) by the physiotherapist', 'timeFrame': '10 weeks'}, {'measure': 'Box and Block test', 'timeFrame': '10 weeks', 'description': 'Box and Block test performed by an occupational therapist'}, {'measure': 'Minnesota test.', 'timeFrame': '10 weeks', 'description': 'Minnesota test performed by an occupational therapist'}, {'measure': 'amplitude of electrodermal responses', 'timeFrame': '10 weeks', 'description': 'mental chronometric assessment associated with acquisition of electrodermal responses'}, {'measure': 'duration of electrodermal responses', 'timeFrame': '10 weeks', 'description': 'mental chronometric assessment associated with acquisition of electrodermal responses'}, {'measure': 'Kinesthetic and Visual Imagery Questionnaire', 'timeFrame': '10 weeks', 'description': 'The Kinesthetic and Visual Imagery Questionnaire (KVIQ) will allow a qualitative evaluation of the mental representation capacity of patients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cervical spinal cord injury', 'Motor imagery', 'Magnetoencephalography'], 'conditions': ['Tetraplegia C5-C6', 'Tetraplegia C6-C7']}, 'referencesModule': {'references': [{'pmid': '29944923', 'type': 'RESULT', 'citation': 'Mateo S, Reilly KT, Collet C, Rode G. Descriptive pilot study of vividness and temporal equivalence during motor imagery training after quadriplegia. Ann Phys Rehabil Med. 2018 Sep;61(5):300-308. doi: 10.1016/j.rehab.2018.06.003. Epub 2018 Jun 23.'}]}, 'descriptionModule': {'briefSummary': 'Single center, pilot study, to evaluate the influence of Motor Imagery (MI) on functional rehabilitation and cerebral plasticity through the qualitative and quantitative mental practice approach. For this, the investigators will use magnetoencephalography (MEG) but also physiological and behavioral indicators developed by the Laboratoire de la Performance Motrice, Mentale et du Matériel (P3M) of Université Claude Bernard Lyon 1 and its partners.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-55 years old,\n* quadriplegia elicited by spinal cord injury (SCI) at the C5, C5-C6, C6, or C6-C7 level,\n* complete infra-lesional motor deficit according to the ASIA impairment scale with finger and forearm flexor muscles paralysis,\n* post-traumatic period \\>6 months (since a motor recovery plateau is usually reached at 6-month post-SCI\n\nExclusion Criteria:\n\n* non-stabilized hypertension or pathological autonomic nervous system dysfunction (e.g., orthostatic hypotension),\n* cerebral damage and/or cognitive deficit,\n* elbow or shoulder joint amplitude restriction, upper limb para-osteoarthropathy,\n* participation to another study\n* presence of metallic objects within the body incompatible with MEG or functional magnetic resonance imaging (fMRI) recordings.'}, 'identificationModule': {'nctId': 'NCT02860403', 'briefTitle': 'Motor Imagery for Reach-to-grasp Rehabilitation After Tetraplegia', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Motor Imagery for Reach-to-grasp Rehabilitation After Tetraplegia', 'orgStudyIdInfo': {'id': '2008-541'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C6-C7 patients', 'description': 'C6-C7 patients able to recover tenodesis grasp.', 'interventionNames': ['Procedure: motor imagery']}, {'type': 'EXPERIMENTAL', 'label': 'C5-C6 patients', 'description': 'C5-C6 patients for whom surgery for rehabilitation of an upper limb is indicated with a upper limit of one year after trauma, and after complete clinical and functional evaluation', 'interventionNames': ['Procedure: motor imagery']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'a control group (n=6) matched on age and sex to C6-C7 without medical history or neurological disorder'}], 'interventions': [{'name': 'motor imagery', 'type': 'PROCEDURE', 'description': 'Intervention consisted of supervised MI during which the participants were trained to imagine performing a single-joint wrist extension movement and a multiple-joint reach-to-grasp movement using tenodesis. The two movements were practiced in separate blocks and each 45 minute MI session consisted of six to eight blocks. Within a given block patients; i) performed the movement once, ii) imagined it using visual imagery (between five and ten repetitions), iii) performed the movement again, and iv) imagined it using kinesthetic imagery (between five and ten repetitions). All movements (performed and imagined) were timed by the experimenter to ensure that the durations of both imagined and physically practiced movements were similar. Imagery vividness was controlled with self-rated assessments using a visual analogic scale (from 0, the image or feeling was absent, to 10 when it was as clear or intense as physical practice).', 'armGroupLabels': ['C5-C6 patients', 'C6-C7 patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69230', 'city': 'Saint-Genis-Laval', 'country': 'France', 'facility': 'Hôpital Henry Gabrielle - Médecine physique et Réadaptation, Hospices Civils de Lyon, 20 Route de Vourles,', 'geoPoint': {'lat': 45.69542, 'lon': 4.79316}}], 'overallOfficials': [{'name': 'Gilles RODE, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}