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Clinical Trials in Italy / NCT07860827
Recruiting Not applicable

Efficacy of Robotic Upper Limb Rehabilitation Training in Patients With Tetraplegia

NCT07860827 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Sacro Cuore Don Calabria di Negrar
Phase
Not applicable
Started
2024-04-01
Last updated
2026-10-06

Condition(s) studied

Tetraplegia/TetraparesisRehabilitation TreatmentGaining Skeletal Muscle Mass and Strength

Investigational drug(s) / intervention(s)

Robotic Rehabilitation with PABLO®Standard Gym Rehabilitation

Robotic Rehabilitation with PABLO®: 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. Treatments 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.

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Neurological assessment of motor function and sensation — From enrollment (Visit 0) to Visit 3 (7-9 weeks after Visit 0)
    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/adduction, internal and external rotation of the shoulder, and flexion-extension of the elbow), administered both before and after treatment.

Trial sites (1)

FacilityCityRegionStatus
IRCCS Sacro Cuore Don Calabria Hospital Negrar Veneto Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07860827 on ClinicalTrials.gov ↗ ← All trials in Italy