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NCT07860827
Efficacy of Robotic Upper Limb Rehabilitation Training in Patients With Tetraplegia
Conditions: Tetraplegia/Tetraparesis, Rehabilitation Treatment, Gaining Skeletal Muscle Mass and Strength
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 24
Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
Location: IRCCS Sacro Cuore Don Calabria Hospital Negrar Veneto
Summary
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/tetraparesis due to spinal cord injury of various etiologies (traumatic, ischemic, infectious, etc.) in the subacute phase.
Eligibility Criteria
Inclusion Criteria:
1. PRIMARY
* The investigator obtains the patient's informed consent to participate in the clinical trial and to the processing of personal data.
* Tetraplegic/tetraparetic 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 ≥2/5)-in the muscles of the scapulohumeral region and the elbow on at least one side of the body.
* Age ≥ 18 years and ≤ 80 years.
* Time interval between the acute event and study enrollment not exceeding 120 days.
2. SECONDARY
* Ability to maintain a seated position in a non-reclined wheelchair (trunk-pelvis angle of 90°) for one hour.
* 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.
Exclusion Criteria:
* ASIA with a neurological level of C2 or higher.
* Previous cerebrovascular events, neurodegenerative disorders, or spinal cord injuries that have resulted in motor and/or cognitive impairment.
* History of major psychiatric disorders.
* Concurrent traumatic brain injury during the acute phase.
* Previous orthopedic conditions of the shoulder resulting in severe functional impairment.
* Active rheumatological conditions.
* Severe uncorrected visual impairment (such that it prevents the patient from viewing the computer-based exercises proposed by the robot).
Source: ClinicalTrials.gov (NCT07860827). StuddyBuddy aggregates publicly available trial information.