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

NCT ID: NCT06906588

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-19
• Study Completion Date: 2026-12-31

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.

Conditions

Stroke; Sabacute Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Group (EG)

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.

Group Type: EXPERIMENTAL

Experimental

Intervention Type: 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 Group (CG)

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.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

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.

Interventions

Experimental

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.

Intervention Type: DEVICE

Control

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Italy

OTHER_GOV

Sponsor Role: collaborator

IRCCS San Raffaele Roma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Sanaz Pournajaf, DPT

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Raffaele Roma

Prof. Marco Franceschini, MD

Role: STUDY_CHAIR

IRCCS San Raffaele Roma

Locations

San Raffaele Cassino

Cassino, Italy, Italy

Site Status: NOT_YET_RECRUITING

IRCCS San Raffaele Roma

Rome, Italy, Italy

Site Status: RECRUITING

San Raffaele Sulmona

Sulmona, Italy, Italy

Site Status: NOT_YET_RECRUITING

Countries

Italy

Central Contacts

Dr. Sanaz Pournajaf, DPT

Role: CONTACT

sanaz.pournajaf@sanraffaele.it

+39-06-52252405 ext. 32405

Dr. Elena Sofia Cocco, Bioengineer

Role: CONTACT

elenasofia.cocco@sanraffaele.it

Facility Contacts

Prof. Maria Francesca De Pandis, MD, PhD

Role: primary

maria.depandis@sanraffaele.it

+39 0776 394740

Dr. Sanaz Pournajaf, DPT, PhD (cand.)

Role: primary

sanaz.pournajfa@sanraffaele.it

+39 0652252405 ext. 32405

Dr. Giorgio Felzani, MD

Role: primary

giorgio.felzani@sanraffaele.it

+39 0864 2507400

References

Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke. 2003 Sep;34(9):2181-6. doi: 10.1161/01.STR.0000087172.16305.CD. Epub 2003 Aug 7.

Reference Type: BACKGROUND

PMID: 12907818 (View on PubMed)

Mehrholz J, Pohl M, Platz T, Kugler J, Elsner B. Electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2018 Sep 3;9(9):CD006876. doi: 10.1002/14651858.CD006876.pub5.

Reference Type: BACKGROUND

PMID: 30175845 (View on PubMed)

Morone G, Palomba A, Martino Cinnera A, Agostini M, Aprile I, Arienti C, Paci M, Casanova E, Marino D, LA Rosa G, Bressi F, Sterzi S, Gandolfi M, Giansanti D, Perrero L, Battistini A, Miccinilli S, Filoni S, Sicari M, Petrozzino S, Solaro CM, Gargano S, Benanti P, Boldrini P, Bonaiuti D, Castelli E, Draicchio F, Falabella V, Galeri S, Gimigliano F, Grigioni M, Mazzoleni S, Mazzon S, Molteni F, Petrarca M, Picelli A, Posteraro F, Senatore M, Turchetti G, Straudi S; "CICERONE" Italian Consensus Conference on Robotic in Neurorehabilitation. Systematic review of guidelines to identify recommendations for upper limb robotic rehabilitation after stroke. Eur J Phys Rehabil Med. 2021 Apr;57(2):238-245. doi: 10.23736/S1973-9087.21.06625-9. Epub 2021 Jan 25.

Reference Type: BACKGROUND

PMID: 33491943 (View on PubMed)

Iosa M, Morone G, Ragaglini MR, Fusco A, Paolucci S. Motor strategies and bilateral transfer in sensorimotor learning of patients with subacute stroke and healthy subjects. A randomized controlled trial. Eur J Phys Rehabil Med. 2013 Jun;49(3):291-9. Epub 2012 Nov 20.

Reference Type: BACKGROUND

PMID: 23172404 (View on PubMed)

Frisoli A, Barsotti M, Sotgiu E, Lamola G, Procopio C, Chisari C. A randomized clinical control study on the efficacy of three-dimensional upper limb robotic exoskeleton training in chronic stroke. J Neuroeng Rehabil. 2022 Feb 4;19(1):14. doi: 10.1186/s12984-022-00991-y.

Reference Type: BACKGROUND

PMID: 35120546 (View on PubMed)

Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011;9(8):672-7. doi: 10.1016/j.ijsu.2011.09.004. Epub 2011 Oct 13. No abstract available.

Reference Type: BACKGROUND

PMID: 22019563 (View on PubMed)

Calabro RS, Naro A, Russo M, Milardi D, Leo A, Filoni S, Trinchera A, Bramanti P. Is two better than one? Muscle vibration plus robotic rehabilitation to improve upper limb spasticity and function: A pilot randomized controlled trial. PLoS One. 2017 Oct 3;12(10):e0185936. doi: 10.1371/journal.pone.0185936. eCollection 2017.

Reference Type: BACKGROUND

PMID: 28973024 (View on PubMed)

Demeyere N, Riddoch MJ, Slavkova ED, Bickerton WL, Humphreys GW. The Oxford Cognitive Screen (OCS): validation of a stroke-specific short cognitive screening tool. Psychol Assess. 2015 Sep;27(3):883-94. doi: 10.1037/pas0000082. Epub 2015 Mar 2.

Reference Type: BACKGROUND

PMID: 25730165 (View on PubMed)

Mancuso M, Varalta V, Sardella L, Capitani D, Zoccolotti P, Antonucci G; Italian OCS Group. Italian normative data for a stroke specific cognitive screening tool: the Oxford Cognitive Screen (OCS). Neurol Sci. 2016 Oct;37(10):1713-21. doi: 10.1007/s10072-016-2650-6. Epub 2016 Jul 9.

Reference Type: BACKGROUND

PMID: 27395388 (View on PubMed)

Other Identifiers

93/SR/24

Identifier Type: -

Identifier Source: org_study_id