Active — Not RecruitingPhase 4

Upper Limb Robot-Assisted Therapy in Patients with Guillain-Barré Syndrome

Italy62 participantsStarted 2024-10-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Diagnosis of Guillan-Barré Syndrome;
✓. UL motor impairment (0-4 in the Medical Research Council scale);
✓. sub-acute phase (until 180 days);
✓. Patients able to maintain the sitting position.

Exclusion criteria

✕. Concomitant neurological, orthopedic, metabolic, and oncological diseases;
✕. Cognitive impairment assessed with the Mini Mental State Examination (score under 24 points);
✕. Visual deficit;
✕. Hearing disorders.

What they're measuring

Fugl-Meyer Assessment scale for Upper Extremity (FMAUE)

Timeframe: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).

Trial details

NCT IDNCT06620198

SponsorI.R.C.C.S. Fondazione Santa Lucia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-01

View on ClinicalTrials.gov More Guillain Barré Syndrome trials