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Active Not Recruiting
NCT06620198
Upper Limb Robot-Assisted Therapy in Patients With Guillain-Barré Syndrome
Conditions: Guillain Barré Syndrome
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 62
Sponsor: I.R.C.C.S. Fondazione Santa Lucia
Location: IRCCS Santa Lucia Foundation Rome Lazio
Summary
Guillain-Barré Syndrome is an immune-mediated polyradiculoneuropathy, with around 100,000 new cases reported worldwide annually.
The aim of this double-blind randomized controlled trial with a SHAM control group is to evaluate the effects of robot-assisted therapy, integrated with conventional therapy, on upper limb motor recovery in patients with GBS.
Eligibility Criteria
Inclusion Criteria:
1. Diagnosis of Guillan-Barré Syndrome;
2. UL motor impairment (0-4 in the Medical Research Council scale);
3. sub-acute phase (until 180 days);
4. Patients able to maintain the sitting position.
Exclusion Criteria:
1. Concomitant neurological, orthopedic, metabolic, and oncological diseases;
2. Cognitive impairment assessed with the Mini Mental State Examination (score under 24 points);
3. Visual deficit;
4. Hearing disorders.
Source: ClinicalTrials.gov (NCT06620198). StuddyBuddy aggregates publicly available trial information.