Guillain Barré Syndrome
Conditions
Keywords
Polyradiculopathy, Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Polyradiculoneuropathy, Exoskeleton device, Robotic Rehabilitation
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.
Interventions
DEVICEArmeo® Power 2 Exoskeleton - Active Rehabilitation with Feedback and Exercise Gaming
Patients will undergo 20 session of 45 minutes each with an exoskeleton for upper limb rehabilitation. The assistance provided by the device is adjusted based on the maximum force (as a percentage of the upper limb's weight) the robot needs to exert to assist the patient's movements. Each session will include exercises designed to improve the range of motion (ROM) of the shoulder, elbow, wrist, and enhance hand coordination. The training parameters, such as difficulty level, duration, and visual stimuli, will be adjusted based on the patient's residual abilities. The selected exercises may involve movements of a single joint along one axis, combined movements of a single joint around 2 or 3 axes, selective exercises for the opening and closing hand, or multi-joint exercises. All exercises will be realized with audiovisual feedback.
DEVICEArmeo® Power 2 Exoskeleton - Passive Mobilization without Feedback
Patients will undergo 20 session of 45 minute of a neurorehabilitation intervention with a SHAM treatment under the guidance of the experimental therapist. This will involve passive mobilization using the exoskeleton for the upper limb, without any audiovisual feedback. They will not realize any active movement during the training.
Sponsors
I.R.C.C.S. Fondazione Santa Lucia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Assessors, Patients and their caregivers will be blinded for the entire duration of the study.
Intervention model description
Randomized Clinical Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment scale for Upper Extremity (FMAUE) | 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
| Measure | Time frame | Description |
|---|---|---|
| The 36-Item Short-Form Health Survey (SF-36) | Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3). | The SF-36 will be used to assess the change in health-related quality of life. The SF-36 is organized into 8 different domains that are divided into physical components (Physical functioning, limitations due to physical problems, bodily pain and general perceptions of health status) and mental components (Social functioning, general mental health, limitations due to emotional problems and vitality). Each of the 8 domain scores, added together, is linearly transformed on a scale from 0 to 100, where 0 equals negative health and 100 equals positive health. |
| modified Barthel Index (mBI) | Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3). | The mBI will be used to assess the change in the autonomy of patients during their activities of daily living. This scale has a score ranging from 0 to 100 points, a higher score corresponds to a better performance in the activities of daily living. |
| ABILHAND | Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3). | The ABILHAND will be used to assess manual dexterity. The ABILHAND is a questionnaire-based assessment tool that measures the difficulty a patient perceives in using their hands to perform manual operations and activities in daily living. It assesses upper limb functionality. It has nonlinear logit values ranging from 1.72 to -2.18. |
| The nine hole peg test (NHPG). | Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3). | The NHPG will be used to assess fine manual dexterity. The NHPT consists of a square board with 9 pegs. At one end of the board are holes to insert the pegs, and at the other end is a shallow round plate to store the extracted pegs. The NHPT is administered by asking the patient to take the pegs from a container, one by one, and insert them into the holes on the board, as quickly as possible. |
| Grip strength | Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3). | Grip strength will be assessed using a manual digital dynamometer. The maximum strength of the whole hand will be recorded for three times without feedback (with the patient sitting with his back to the monitor). |
| The Medical Research Council scale (MRC) | Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3). | The MRC will be used to assess muscle strength. The score ranges from 0 to 5 where 0 equals no muscle recruitment and 5 normal muscle force. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mini-Mental State Examination (MMSE) | T0 (Baseline) | MMSE is a widely used psychometric tool in clinical settings to assess cognitive function. It is employed to detect cognitive impairments, monitor the progression of neurodegenerative diseases such as Alzheimer disease, and evaluate the severity of cognitive decline. The test consists of a series of questions and tasks that assess various cognitive domains, including orientation in time and space, memory, attention, language, and the ability to follow simple commands. |
Countries
Italy
Outcome results
None listed