Robotic upper-limb rehab vs standard therapy for adults with tetraplegia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In adults with tetraplegia from spinal cord injury, the trial compares two 3-week training approaches after an initial standard upper-limb rehab period. One group uses a robotic rehabilitation device (PABLO®) for the upper limb, while the other continues with standard physiotherapy. Assessments include the ASIA Impairment Scale for neurological status and the MRC scale for proximal upper-limb strength, with evaluations at baseline, after the standard rehab period, after the training phase, and at the end of the study. Participants are randomized after a 2–4 week hospitalization and must meet specific motor and stability criteria.

Why it matters

Who can join: the full rules

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).

Where it's running

• IRCCS Sacro Cuore Don Calabria Hospital
  Negrar, Veneto, Italy Recruiting

Study contacts

• Study coordinator: Elvia Malo, Dr.ssa
• Email: ricerca.clinica@sacrocuore.it
• Phone: +39 045.6014877

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.