Effects of Robot-Assisted Therapy for Upper Limb Functional Recovery in Patients with Guillain-Barré Syndrome: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 62
- Locations
- 2
- Primary Endpoint
- Fugl-Meyer Assessment scale for Upper Extremity (FMAUE)
Study Overview
Brief 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.
Detailed Description
Guillain-Barré Syndrome is a leading cause of acute flaccid paralysis, presenting with limb weakness and hyporeflexia or areflexia. Guillain-Barré Syndrome is an immune-mediated polyradiculoneuropathy, with around 100,000 new cases reported worldwide annually. This study aims to assess the effectiveness of a robot-assisted rehabilitation treatment for upper limb motor recovery in patients with Guillain-Barré Syndrome. A double-blind randomized trial will be conducted, where the experimental group will undergo actual robotic rehabilitation sessions, while the control group will perform sessions in which the robot will carry out simple mobilization, comparable to traditional interventions. This approach will help maintain participant blinding. Patients will be evaluated before and after treatment, and with two follow-up assessments 60 and 90 days after therapy initiation. Evaluations will include muscle recruitment and autonomy in daily living activities.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Assessors, Patients and their caregivers will be blinded for the entire duration of the study.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Fugl-Meyer Assessment scale for Upper Extremity (FMAUE)
Time Frame: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
THE FMAUE will be used to assess the change in the motor and sensory functions of the upper limb. The FMAUE included five domains: motor functioning, sensitivity, coordination, range of motion and pain. The score ranging from 0 to 66 points, a higher score corresponds to a better function of the upper limb.
Secondary Outcomes
- The 36-Item Short-Form Health Survey (SF-36)(Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).)
- modified Barthel Index (mBI)(Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).)
- ABILHAND(Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).)
- The Medical Research Council scale (MRC)(Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).)
- The nine hole peg test (NHPG).(Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).)
- Grip strength(Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).)