Clinical trial NCT06620198: Upper Limb Robot-Assisted Therapy in Patients with Guillain-Barré Syndrome
Official title: Effects of Robot-Assisted Therapy for Upper Limb Functional Recovery in Patients with Guillain-Barré Syndrome: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Guillain Barré Syndrome
Keywords: Polyradiculopathy
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Polyradiculoneuropathy
Exoskeleton device
Robotic Rehabilitation
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Fugl-Meyer Assessment scale for Upper Extremity (FMAUE)
timeFrame: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
Secondary outcomes:
measure: The 36-Item Short-Form Health Survey (SF-36)
timeFrame: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
measure: modified Barthel Index (mBI)
timeFrame: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
measure: ABILHAND
timeFrame: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
measure: The Medical Research Council scale (MRC)
timeFrame: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
measure: The nine hole peg test (NHPG).
timeFrame: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
measure: Grip strength
timeFrame: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
Other outcomes:
measure: Mini-Mental State Examination (MMSE)
timeFrame: T0 (Baseline)
Locations:
city: Rome
country: Italy
facility: IRCCS Santa Lucia Foundation
state: Lazio
Study officials:
affiliation: IRCCS Santa Lucia Foundation
name: Alex Martino Cinnera, PhD
role: STUDY_CHAIR
affiliation: IRCCS Santa Lucia Foundation
name: Diego Piatti, BSc
role: STUDY_CHAIR
affiliation: IRCCS Santa Lucia Foundation
name: Laura Casagrande Conti, MSc
role: STUDY_DIRECTOR
affiliation: IRCCS Santa Lucia Foundation
name: Martina D Arienzo, BSc
role: STUDY_DIRECTOR
References: