About this trial

The goal of this clinical trial is to study the clinical effects of a robotic rehabilitation treatment through a bilateral exoskeleton (Bilateral Robot-Assisted Therapy-BRAT) during standard rehabilitation, on motor recovery, compared to conventional arm re-education in people suffering from stroke in the subacute phase. The main question it aims to answer is what the effectiveness of Bilateral Robot-Assisted Therapy (BRAT) is in rehabilitating the upper limb in individuals with subacute stroke compared to conventional rehabilitation treatment in terms of motor function improvement as measured by the Fugl-Meyer Assessment - Upper Limb (FMA-UL), motor domain. Researchers will compare two groups (Experimental Group - EG and Control Group - CG) to see if the BRAT is more effective than conventional rehabilitation treatment in terms of motor recovery. Participants will be randomly assigned to one of the two treatment groups (EG or CG) and will be clinically and instrumentally evaluated at baseline (T0) and at the end of treatment (T1). EG, in addition to the standard rehabilitation treatment, will perform a 45-minute session of BRAT per day through the Arm Light Exoskeleton Hybrid (Alex RS - Wearable Robotics) robotic system. The CG, in addition to the standard routine rehabilitation treatment, will follow a conventional rehabilitation of the upper limbs without the use of technological devices. Finally, a telephone follow-up is scheduled three months after the end of the treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Both sexes;

Age >18 years;

Unilateral hemipyramidal syndrome as demonstrated by a brain CT or MRI;

Distance from acute event < 6 months;

Disqualifiers

Unstable general clinical conditions;

Bilateral pyramidal hemisyndrome severe visual impairment;

Recent injection of Botulinum Toxin to the affected upper limb or planned for the duration of the study;

Interruption of treatment for 1 week or 5 consecutive sessions;

Trial design

Design model

Parallel

Treatments tested in this trial

Experimental
Device
The experimental group (EG), in addition to the standard rehabilitation treatment, will perform one upper limb BRAT session per day through the Arm Light Exoskeleton Hybrid (Alex RS - Wearable Robotics) robotic system.. Each participant will perform a total of 16+/-3 treatment sessions with a frequency of 4 times a week for 4 consecutive weeks. During the first session, the device should be adjusted according to the patient's bilateral size and suspension angle. The selection of personalized exercises will be based on each patient's motor skills and the difficulty can be gradually increased during the treatment period. These modalities are shown to the patient with visual and motor feedback (force feedback). The duration of the single rehabilitation treatment is 45 minutes, of which 5 minutes are used for setting up the device, 10 minutes for assembly/disassembly, 10 minutes for unilateral treatment with the affected upper limb and 20 minutes for bilateral treatment.
Control
Other intervention
The control group (GC), in addition to the standard routine rehabilitation treatment, will follow 45 minutes of conventional rehabilitation of the upper limbs without the use of technological devices. Each participant will perform a total of 16+/-3 conventional upper limb treatment sessions with a frequency of 4 times a week for 4 weeks. The motor exercises will concern the rehabilitation of the upper limb and will be performed with a therapist who will personalize the treatment based on the clinical characteristics and needs of the patient. Specifically, the treatment of the upper limb will be characterized by motor exercises (shoulder, elbow, wrist and hand), coordination and manual dexterity. Each session will consist of passive, active-assisted and active exercises.

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: Experimental Group (EG)Experimental treatment 1 intervention

Group B: Control Group (CG)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Upper Limb Fugle Meyer Assessment - Motor Part (score range: 0-66)

The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The Fugl-Meyer Assessment (FMA) is a widely used clinical tool to assess motor recovery in individuals who have experienced a stroke. It is designed to measure motor function, sensory function, balance, and joint range of motionin individuals with hemiplegia (one-sided paralysis or weakness), which is common following a stroke.

Time frame