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

NCT06906588 | Recruiting DMC

• 1 other identifier: 93/SR/24
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

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.

Conditions

Stroke; Sabacute Stroke

Keywords

Upper limb rehabilitation; Bilateral Robot-Assisted Therapy-BRAT; stroke; subacute; Robotic rehabilitation

Outcome Measures

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.

  Day 0 (T0- basline) and day 28 (T1 - After treatment)

Secondary Outcomes (9)

• Oxford Cognitive Scale (OCS)

  Day 0 (T0- basline) and day 28 (T1 - After treatment)

• Modified Ashworth Scale (MAS) 0-4

  Day 0 (T0- basline) and day 28 (T1 - After treatment)

• Box and Block test (BBT)

  Day 0 (T0- basline) and day 28 (T1 - After treatment)

• Nine Hole Peg Test (NHPT)

  Day 0 (T0- basline) and day 28 (T1 - After treatment)

• ABILHAND

  Day 0 (T0- basline) and day 28 (T1 - After treatment)

Other Outcomes (3)

• Instrumental robotic assessment

  Day 0 (T0- basline) and day 28 (T1 - After treatment)

• Instrumental neurophysiological assessments

  Day 0 (T0- basline) and day 28 (T1 - After treatment)

• IMU-based targeted Box and Block Test (t-BBT)

  Day 0 (T0- basline) and day 28 (T1 - After treatment)

Study Arms (2)

Experimental Group (EG)

EXPERIMENTAL

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.

Device: Experimental

Control Group (CG)

ACTIVE COMPARATOR

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.

Other: Control

Interventions

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.

Experimental Group (EG)

Control 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.

Control Group (CG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead
• Ministry of Health, Italy: collaborator

Study Sites (3)

San Raffaele Cassino

Cassino, Italy, 03043, Italy

NOT YET RECRUITING

IRCCS San Raffaele Roma

Rome, Italy, 00166, Italy

RECRUITING

San Raffaele Sulmona

Sulmona, Italy, 67039, Italy

NOT YET RECRUITING

Related Publications (9)

• 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.

  PMID: 12907818 BACKGROUND

• 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.

  PMID: 30175845 BACKGROUND

• 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.

  PMID: 33491943 BACKGROUND

• 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.

  PMID: 23172404 BACKGROUND

• 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.

  PMID: 35120546 BACKGROUND

• 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.

  PMID: 22019563 BACKGROUND

• 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.

  PMID: 28973024 BACKGROUND

• 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.

  PMID: 25730165 BACKGROUND

• 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.

  PMID: 27395388 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dr. Sanaz Pournajaf, DPT

  IRCCS San Raffaele Roma

  PRINCIPAL INVESTIGATOR

• Prof. Marco Franceschini, MD

  IRCCS San Raffaele Roma

  STUDY CHAIR

Central Study Contacts

Dr. Sanaz Pournajaf, DPT

CONTACT

+39-06-52252405; sanaz.pournajaf@sanraffaele.it

Dr. Elena Sofia Cocco, Bioengineer

CONTACT

elenasofia.cocco@sanraffaele.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: May 19, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Individual participant data (IPD) will be available upon publication of the main results and will remain accessible for at least five years.
• Access Criteria: Qualified researchers may request access to the data by submitting a proposal outlining their research objectives. Access will be granted upon ethical and regulatory approval and under a data-sharing agreement.

Locations

IT (3)