[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659113":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":43,"studyPopulation":34,"armGroups":44,"interventions":55,"overallOfficials":34,"centralContacts":65,"locations":71,"responsibleParty":91,"collaborators":34,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":95,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":34,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":115,"overallStatus":74,"whyStopped":34,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"IRCCS Sacro Cuore Don Calabria di Negrar","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Neurological assessment of motor function and sensation","Neurological assessment of motor function and sensation using the American Spinal Injury Association (ASIA) Impairment Scale. Assessment of muscle strength using the Medical Research Council (MRC) scale for the proximal muscles of the upper limb and the scapulohumeral region (flexion-extension, abduction\u002Fadduction, internal and external rotation of the shoulder, and flexion-extension of the elbow), administered both before and after treatment.","From enrollment (Visit 0) to Visit 3 (7-9 weeks after Visit 0)",[14,17,21,24,27,30],{"measure":15,"description":16,"timeFrame":12},"Passive Range of Motion (pROM)","Passive Range of Motion (pROM) at the scapulohumeral joint across various planes of motion (flexion-extension, abduction\u002Fadduction, internal and external rotation of the shoulder, and flexion-extension of the elbow), measured both pre- and post-treatment",{"measure":18,"description":19,"timeFrame":20},"Numerical Rating Scale (NRS)","Numerical Rating Scale (NRS) for assessing shoulder pain, recorded at all visits, both pre- and post-treatment;","From Visit 1 (2-4 weeks after Visit 0) to Visit 3 (7-9 weeks after Visit 0)",{"measure":22,"description":23,"timeFrame":12},"Spinal Cord Independence Measure (SCIM-III) scale","Spinal Cord Independence Measure (SCIM-III) scale, measured both pre- and post-treatment",{"measure":25,"description":25,"timeFrame":26},"number of sessions required before beginning 2D exercises","At Visit 2 (4-6 weeks after Visit 0) and Visit 3 (7-9 after Visit 0)",{"measure":28,"description":29,"timeFrame":26},"Wheelchair Skills Test Italian Version 4.3 Powered Mobility Devices (WST-I 4.3 PMD)","Wheelchair Skills Test Italian Version 4.3 Powered Mobility Devices (WST-I 4.3 PMD), measured pre- and post-treatment",{"measure":31,"description":32,"timeFrame":33},"Modified Physical Therapy Patient Satisfaction Questionnaire (PTPSQ-1 mod)","Modified Physical Therapy Patient Satisfaction Questionnaire (PTPSQ-1 mod), completed during the final visit","At Visit 3 (7-9 weeks after Visit 0)",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":38,"observationalModel":34,"timePerspective":34,"maskingInfo":39},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":40,"maskingDescription":34,"whoMasked":41},"SINGLE",[42],"OUTCOMES_ASSESSOR","The rehabilitation protocol includes:\n\n\\- 2 weeks of standard upper limb gym rehabilitation treatment;\n\nRandomization of patients into two treatment groups (lasting 3 weeks):\n\n* Arm A, undergoing upper-limb treatment solely with a robotic device;\n* Arm B, undergoing only standard physiotherapy treatment\n\nFor the evaluation of neurological assessment of motor and sensory functions will be used the American Spinal Injury Association (ASIA) Impairment Scale.\n\nSpecifically, the assessment of muscle strength of proximal muscles of the upper limb and the scapulohumeral region will be used the Medical Research Council (MRC) scale.\n\nThe enrollment evaluation (V0) consists of a physiatric examination, including an assessment of motor function and muscle strength in the scapulohumeral region and the proximal portions of the upper limbs, as well as any sensory deficits in the upper limbs, followed by determination of the neurological level of injury and classification according to the ASIA Impairment Scale. After two to four weeks of hospitalization, during which the patient undergoes standard rehabilitation, the examiner reevaluates the patient (V1).\n\nAfter two weeks of standard upper-limb rehabilitation, the patient undergoes a further clinical reevaluation (V2) and is subsequently randomized into two treatment groups: Arm A (experimental arm) or Arm B (standard control arm). At the end of this training period, the patient will be re-evaluated (V3) by the same examiner who conducted the V1 visit and who will be blinded to the rehabilitation treatment received by the patient (the patient will be asked not to disclose the type of rehabilitation performed).",[45,50],{"label":46,"type":47,"description":34,"interventionNames":48},"Robotic Rehabilitation with PABLO®","EXPERIMENTAL",[49],"Device: Robotic Rehabilitation with PABLO®",{"label":51,"type":52,"description":34,"interventionNames":53},"Standard Rehabilitation","ACTIVE_COMPARATOR",[54],"Procedure: Standard Gym Rehabilitation",[56,60],{"type":57,"name":46,"description":58,"armGroupLabels":59,"otherNames":34},"DEVICE","3 weeks of robotic rehabilitation treatment with PABLO®, consisting of 15 rehabilitation sessions, each lasting 1 hour, for the upper limbs, focused on restoring strength and motor function.\n\nTreatments involve one-dimensional (lateral-lateral or anteroposterior) and two-dimensional active mobilization of the upper extremities using the PABLO® Multiboard, a device that secures the hand and wrist with a handle and allows for flexion and extension movements of the elbow and shoulder.",[46],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":34},"PROCEDURE","Standard Gym Rehabilitation","3 weeks of standard rehabilitation treatment, consisting of 15 rehabilitation sessions in the gym (5 per week for 3 consecutive weeks), each lasting 1 hour. Treatments are designed to maintain or restore range of motion in the shoulder joint through passive, active-assisted, and active mobilization exercises guided by the physical therapist, strength training of the proximal muscles of the upper limb, electrostimulation of the proximal muscles of the upper limb and use of physical therapies for analgesic and anti-inflammatory purposes.",[51],[66],{"name":67,"role":68,"phone":69,"phoneExt":34,"email":70},"Elvia Malo, Dr.ssa","CONTACT","+39 045.6014877","ricerca.clinica@sacrocuore.it",[72],{"facility":73,"status":74,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"IRCCS Sacro Cuore Don Calabria Hospital","RECRUITING","Negrar","Veneto","37024","Italy","IT",{"type":81,"coordinates":82},"Point",[83,84],10.93899,45.52918,{"lat":84,"lon":83},[87],{"name":88,"role":68,"phone":89,"phoneExt":34,"email":90},"Elena Rossato, Dr.ssa","+39 045.6014597","elena.rossato@sacrocuore.it",{"type":92,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100659113","efficacy-of-robotic-upper-limb-rehabilitation-training-in-patients-with-tetraplegia-100659113",false,"NCT07860827","Efficacy of Robotic Upper Limb Rehabilitation Training in Patients With Tetraplegia","Efficacy of Robotic Upper Limb Rehabilitation Training in Patients With Tetraplegia (TRRAT): A Pilot, Multicenter, Randomized Controlled Trial","TRRAT","Inclusion Criteria:\n\n1. PRIMARY\n\n   * The investigator obtains the patient's informed consent to participate in the clinical trial and to the processing of personal data.\n   * Tetraplegic\u002Ftetraparetic patients with spinal cord injury of various etiologies (traumatic, ischemic, infectious, etc.) as defined by the ASIA Impairment Scale, who are capable of movements at least against gravity-even with a partial range of motion (MRC ≥2\u002F5)-in the muscles of the scapulohumeral region and the elbow on at least one side of the body.\n   * Age ≥ 18 years and ≤ 80 years.\n   * Time interval between the acute event and study enrollment not exceeding 120 days.\n2. SECONDARY\n\n   * Ability to maintain a seated position in a non-reclined wheelchair (trunk-pelvis angle of 90°) for one hour.\n   * Improvement in strength of ≥ 1 point (out of 5) on the MRC scale in less than half of the upper limb regions assessed at Visit V1.\n\nExclusion Criteria:\n\n* ASIA with a neurological level of C2 or higher.\n* Previous cerebrovascular events, neurodegenerative disorders, or spinal cord injuries that have resulted in motor and\u002For cognitive impairment.\n* History of major psychiatric disorders.\n* Concurrent traumatic brain injury during the acute phase.\n* Previous orthopedic conditions of the shoulder resulting in severe functional impairment.\n* Active rheumatological conditions.\n* Severe uncorrected visual impairment (such that it prevents the patient from viewing the computer-based exercises proposed by the robot).","ALL","18 Years","80 Years",{"count":105,"type":106},24,"ESTIMATED","INTERVENTIONAL",[109],"NA","The goal of this clinical trial is to evaluate the efficacy of upper-limb robotic rehabilitation training (PABLO®) for recovering muscle strength in the scapulohumeral region and the proximal upper limb-compared to standard rehabilitation treatment alone-in male and female patients aged 18 to 80 years with tetraplegia\u002Ftetraparesis due to spinal cord injury of various etiologies (traumatic, ischemic, infectious, etc.) in the subacute phase.",[112,113,114],"Tetraplegia\u002FTetraparesis","Rehabilitation Treatment","Gaining Skeletal Muscle Mass and Strength",[116,117,118],"tetraplegia\u002Ftetraparesis","rehabilitation training","PABLO®","2026-09-30",{"date":121,"type":122},"2026-10-06","ACTUAL",{"date":124,"type":122},"2024-04-01",{"date":126,"type":106},"2027-10-31",{"name":5,"class":6},1]