Clinical trial NCT06906588: Bilateral Robot-assisted Upper Extremity Rehabilitation on Motor Recovery in People With Subacute Stroke
Official title: Effects of Bilateral Upper Limb Robot-assisted Rehabilitation on Motor Recovery in Patients With Subacute Stroke: an Italian Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Sabacute Stroke
Keywords: Upper limb rehabilitation
Bilateral Robot-Assisted Therapy-BRAT
stroke
subacute
Robotic rehabilitation
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Italy
First posted: 2025-04-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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. Control group (CG) - conventional treatment for upper limb rehabilitation. The randomization will be carried out in a stratified way to have an even more homogeneous distribution in the two groups of subjects for the prognostic factors that play an important role in the treatment of people with stroke.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Upper Limb Fugle Meyer Assessment - Motor Part (score range: 0-66)
timeFrame: Day 0 (T0- basline) and day 28 (T1 - After treatment)
Secondary outcomes:
measure: Oxford Cognitive Scale (OCS)
timeFrame: Day 0 (T0- basline) and day 28 (T1 - After treatment)
measure: Modified Ashworth Scale (MAS) 0-4
timeFrame: Day 0 (T0- basline) and day 28 (T1 - After treatment)
measure: Box and Block test (BBT)
timeFrame: Day 0 (T0- basline) and day 28 (T1 - After treatment)
measure: Nine Hole Peg Test (NHPT)
timeFrame: Day 0 (T0- basline) and day 28 (T1 - After treatment)
measure: ABILHAND
timeFrame: Day 0 (T0- basline) and day 28 (T1 - After treatment)
measure: Modified Barthel Index (mBI)
timeFrame: Day 0 (T0- basline) and day 28 (T1 - After treatment)
measure: Client Satisfaction Questionnaire (0-24)
timeFrame: Day 28 (T1 - After treatment)
measure: Frenchay Activities Index (FAI)
timeFrame: Day 120 (T2 - 3 months after treatment Follow-Up)
measure: Disability of the Arm, Shoulder, and Hand (DASH) Questionnarie
timeFrame: Day 120 (T2 - 3 months after treatment Follow-Up)
Other outcomes:
measure: Instrumental robotic assessment
timeFrame: Day 0 (T0- basline) and day 28 (T1 - After treatment)
measure: Instrumental neurophysiological assessments
timeFrame: Day 0 (T0- basline) and day 28 (T1 - After treatment)
measure: IMU-based targeted Box and Block Test (t-BBT)
timeFrame: Day 0 (T0- basline) and day 28 (T1 - After treatment)
Locations:
city: Cassino
country: Italy
facility: San Raffaele Cassino
city: Rome
country: Italy
facility: IRCCS San Raffaele Roma
city: Sulmona
country: Italy
facility: San Raffaele Sulmona
Study officials:
affiliation: IRCCS San Raffaele Roma
name: Dr. Sanaz Pournajaf, DPT
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS San Raffaele Roma
name: Prof. Marco Franceschini, MD
role: STUDY_CHAIR
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