Efficacy of Robotic Upper Limb Rehabilitation Training in Patients With Tetraplegia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorIRCCS Sacro Cuore Don Calabria di Negrar
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Robotic Rehabilitation with PABLO®
Device3 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
Procedure/Surgery3 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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Robotic Rehabilitation with PABLO®Experimental treatment 1 intervention
Group B: Standard RehabilitationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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/adduction, internal and external rotation of the shoulder, and flexion-extension of the elbow), administered both before and after treatment.
Time frame
From enrollment (Visit 0) to Visit 3 (7-9 weeks after Visit 0)Secondary outcomes
1
Passive Range of Motion (pROM)
Passive Range of Motion (pROM) at the scapulohumeral joint across various planes of motion (flexion-extension, abduction/adduction, internal and external rotation of the shoulder, and flexion-extension of the elbow), measured both pre- and post-treatment
Time frame
From enrollment (Visit 0) to Visit 3 (7-9 weeks after Visit 0)2
Numerical Rating Scale (NRS)
Numerical Rating Scale (NRS) for assessing shoulder pain, recorded at all visits, both pre- and post-treatment;
Time frame
From Visit 1 (2-4 weeks after Visit 0) to Visit 3 (7-9 weeks after Visit 0)3
Spinal Cord Independence Measure (SCIM-III) scale
Spinal Cord Independence Measure (SCIM-III) scale, measured both pre- and post-treatment
Time frame
From enrollment (Visit 0) to Visit 3 (7-9 weeks after Visit 0)4
number of sessions required before beginning 2D exercises
number of sessions required before beginning 2D exercises
Time frame
At Visit 2 (4-6 weeks after Visit 0) and Visit 3 (7-9 after Visit 0)Sponsors and contacts
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Source ClinicalTrials.gov