Bilateral Robot-assisted Upper Extremity Rehabilitation on Motor Recovery in People With Subacute Stroke (BILAX)

IRCCS San Raffaele Roma

Status: Enrolling

Conditions: Stroke; Sabacute Stroke

Treatments: Device: Experimental; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT06906588

93/SR/24

Details and patient eligibility

About

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.

Full description

Cerebral stroke is one of the major causes of mortality and disability in the world. Upper limb disorders are evident up to 85% of stroke survivors and persist, even 6 months after the acute event, in 55-75% of patients. Recovery of upper limb ability represents a major challenge for neurorehabilitation. Among recent strategies and trends in stroke rehabilitation, robotic technologies are having more space and their application in clinical routine is increasing. The promising effects of robot-assisted therapy for upper limb rehabilitation (Robot-Assisted Therapy-RAT) have been demonstrated in terms of recovery of arm and hand range of motion, muscle strength, thus improving performance of activities of daily living (AVQ). In particular, the latest generation exoskeletal robots have demonstrated their effectiveness, promoting a three-dimensional rehabilitation activity. At the same time, bimanual therapy represents a different training modality which has its solid neuroscientific foundations to improve learning and positively address neuroplasticity phenomena. However, there is no information regarding the effectiveness of these robots on subjects suffering from stroke and in the subacute phase. The primary objective of this RCT is to study the clinical effects of upper limb rehabilitation through a bilateral exoskeleton (Bilateral Robot-Assisted Therapy-BRAT) within standard rehabilitation, on motor recovery, compared to conventional arm re-education in people suffering from stroke in the subacute phase. Secondary objectives of the study include: evaluation of the effectiveness of BRAT on bilateral recovery of arm motor skills and quality of life of study participants; the identification of the characteristics of patients who can benefit most from BRAT in terms of age, distance from the acute event and extent of the motor deficit of the upper limb. The effects of BRAT on motor recovery will also be studied from a neurophysiological (EEG and sEMG) and biomechanical (Inertial Measurement Units-IMU) point of view.The study will develop over 24 months, and includes 3 phases as follows: Phase 1- patient enrollment and screening; Phase 2 Treatment of participants; Phase 3 - Statistical analysis of the data. The study protocol will involve people diagnosed with stroke according to established inclusion and exclusion criteria who will be randomly assigned to one of the following groups: Experimental Group (EG) - robotic treatment for upper limb rehabilitation or Control Group (CG) - conventional treatment for upper limb rehabilitation. The experimental group (EG), in addition to the standard rehabilitation treatment, will perform one 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. All the devices that will be used have the CE (European Conformity) marking. The control group (CG), in addition to the standard routine rehabilitation treatment, will follow a conventional rehabilitation of the upper limbs (16+/-3 treatment sessions) without the use of technological devices. 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. All subjects will be evaluated with a standard clinical objective examination and with clinical rating scales and instrumental assessments. These scales will be administered at baseline (T0), at the end of treatment (T1) and 3 months after the end of treatment (follow-up). The main expected results are: identify a customizable rehabilitation protocol for motor recovery of the upper limb based on the clinical characteristics of each individual patient; achieve better motor recovery both in terms of range of motion and muscle recruitment associated with cognitive stimulation following upper limb rehabilitation through the Alex exoskeleton bilateral robotic assistance system; achieve better muscle activation and therefore better motor performance in the EG; achieve greater autonomy in carrying out daily life activities and consequently greater participation.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Both sexes;
• Age >18 years;
• Unilateral hemipyramidal syndrome as demonstrated by a brain CT or MRI;
• Distance from acute event < 6 months;
• Modified Ashworth Scale (MAS) of shoulder, elbow, and wrist <3;
• Ability to understand and sign the informed consent for the study;
• Ability to perform the study procedures.

Exclusion criteria

• 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;
• Inability to adhere to the exercise program due to poor compliance;
• Presence of neurological pathologies superimposed on the stroke event, psychiatric complications or personality disorders;
• Presence of osteoarticular and neuromuscular pathologies that may compromise the motor skills of the upper limb;
• Participants who have not signed the informed consent to the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Experimental Group (EG)

Experimental group

Description:

The experimental group (EG), in addition to the standard rehabilitation treatment, will perform one Bilateral Robot-Assisted Therapy-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. The device that will be used have the CE (European Conformity) marking.

Treatment:

Device: Experimental

Control Group (CG)

Active Comparator group

Description:

The control group (CG), 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. 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.

Treatment:

Other: Control