The Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke.
NCT ID: NCT04697368
Last Updated: 2025-12-18
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
70 participants
INTERVENTIONAL
2020-12-28
2025-12-24
Brief Summary
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Detailed Description
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Robot-assisted training enables a greater number of repetitive tasks to be practiced in a consistent and controllable manner. Repetitive task training is known to drive Hebbian plasticity, where the wiring of pathways that are coincidently active is strengthened \[5, 6\]. A dose of greater than 20 h of repetitive task training improves upper limb motor recovery following a stroke \[7\] and, therefore, robot-assisted training has the potential to improve arm motor recovery after stroke. We anticipate that Hebbian neuroplasticity, which is learning dependent, will operate regardless of the post-stroke phase. We, hereby, describe the protocol for a multicentre randomized controlled trial to determine whether robot-assisted training improves upper limb function following a stroke in the sub-acute stage.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental Group (EG)
The experimental group (EG), in addition to the standard treatment, will perform one session per day, each lasting 40 minutes, with the Armeo Power robotic system for upper limb rehabilitation. Each subject will perform a total of 25 ± 3 treatment sessions with a frequency of 5 times a week for 5 weeks.
Exoskeleton-Assisted Upper Limb Rehabilitation
The patients will be undergone 25+/-3 Armeo-P training sessions, each lasting 40 minutes (i.e. five times a week for five consecutive weeks). During the first session, the device should be adjusted to the patient's arm size and the angle of suspension. The working space and the exercises will be selected once the UL has been fitted with the system. The selection of personalized exercises will be based on the motor skills of each patient and the difficulty can be gradually increased during training. In particular, a course of exercises has been defined in which the difficulty (suspension rate; the level of assistance; the complexity of movement (1D, 2D, 3D)).
The physiotherapist will choose the modality based on the patient's motor skills (standardized personalized training).
Control Group (CG)
The control group (CG), in addition to the standard routine rehabilitation treatment, will follow 40 minutes of conventional upper limb rehabilitation. Each subject will perform a total of 25 ± 3 conventional upper limb treatment sessions with a frequency of 5 times a week for 5 weeks.
Traditional Upper Limb Rehabilitation
The control group (CG), in addition to the conventional treatment based on the routine rehabilitation program, will follow 25+/-3 sessions of traditional upper limb rehabilitation (i.e. five times a week for five consecutive weeks). Each session will consist of passive, active-assisted, and active exercises addressed for shoulder, arm and hand motor rehabilitation.
Interventions
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Exoskeleton-Assisted Upper Limb Rehabilitation
The patients will be undergone 25+/-3 Armeo-P training sessions, each lasting 40 minutes (i.e. five times a week for five consecutive weeks). During the first session, the device should be adjusted to the patient's arm size and the angle of suspension. The working space and the exercises will be selected once the UL has been fitted with the system. The selection of personalized exercises will be based on the motor skills of each patient and the difficulty can be gradually increased during training. In particular, a course of exercises has been defined in which the difficulty (suspension rate; the level of assistance; the complexity of movement (1D, 2D, 3D)).
The physiotherapist will choose the modality based on the patient's motor skills (standardized personalized training).
Traditional Upper Limb Rehabilitation
The control group (CG), in addition to the conventional treatment based on the routine rehabilitation program, will follow 25+/-3 sessions of traditional upper limb rehabilitation (i.e. five times a week for five consecutive weeks). Each session will consist of passive, active-assisted, and active exercises addressed for shoulder, arm and hand motor rehabilitation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* first stroke with neurological outcomes affecting the upper limb;
* patients with severe or moderate hemiparesis (FM-UL≤44), stratified according to severe (FM-UL ≤ 22) or moderate (22 \<FM-UL ≤ 44) motor deficit;
* patients in the sub-acute phase within 90 days of the acute event, stratified by the distance from the acute event (OAI≤30; OAI\> 30);
* Modified Ashworth Scale (MAS) of the main components (shoulder, elbow, and wrist) of the upper limb \<3;
* sufficient cognitive and linguistic level to understand the instructions and provide consent;
* signed informed consent.
Exclusion Criteria
* severe visual impairment;
* inability to maintain the sitting position;
* mild motor deficit of the arm (FM-UL\> 44) at baseline;
* recent botox injection in the upper limb or planned botox injection during the study period, including the follow-up;
* inability to don the orthosis on the impaired upper limb;
* bone instability in relevant areas of the upper extremity (unconsolidated fractures, fractures due to osteoporosis);
* fixed contractures involving the impaired upper limb (e.g. frozen shoulder);
* shoulder instability;
* severe pain syndromes caused or intensified by rehabilitation with Armeo Power;
* patients who need isolation for infectious diseases ;
* epileptic disorder with frequent attacks that carry the risk of having a seizure during rehabilitation with Armeo Power;
* history of physical or neurological conditions that interfere with study procedures or assessment of motor function;
* interruption of treatment for 1 week, or 5 consecutive sessions;
* participation in other innovative treatment protocols for the upper limb rehabilitation (e.g. robotics, virtual reality, AOT ... etc).
18 Years
85 Years
ALL
No
Sponsors
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Università degli Studi di Ferrara
OTHER
Fondazione Gli Angeli di Padre Pio
UNKNOWN
Azienda Ospedaliero, Universitaria Ospedali Riuniti
OTHER
IRCCS Centro Neurolesi Bonino Pulejo
OTHER
I.R.C.C.S. Fondazione Santa Lucia
OTHER
Presidio Ospedaliero Accreditato Villa Bellombra S.p.A
UNKNOWN
Ministry of Health, Italy
OTHER_GOV
IRCCS San Raffaele Roma
OTHER
Responsible Party
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Principal Investigators
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Marco Franceschini, Prof.
Role: PRINCIPAL_INVESTIGATOR
IRCCS San Raffaele Pisana
Locations
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Villa Bellombra
Bologna, , Italy
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara, , Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti
Foggia, , Italy
IRCCS Centro Neurolesi Bonino Pulejo
Messina, , Italy
IRCCS San Raffaele Pisana
Roma, , Italy
IRCCS fondazione Santa Lucia
Rome, , Italy
Fondazione "Gli Angeli di Padre Pio"
San Giovanni Rotondo, , Italy
Countries
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References
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Tibaek M, Dehlendorff C, Jorgensen HS, Forchhammer HB, Johnsen SP, Kammersgaard LP. Increasing Incidence of Hospitalization for Stroke and Transient Ischemic Attack in Young Adults: A Registry-Based Study. J Am Heart Assoc. 2016 May 11;5(5):e003158. doi: 10.1161/JAHA.115.003158.
Fang MC, Coca Perraillon M, Ghosh K, Cutler DM, Rosen AB. Trends in stroke rates, risk, and outcomes in the United States, 1988 to 2008. Am J Med. 2014 Jul;127(7):608-15. doi: 10.1016/j.amjmed.2014.03.017. Epub 2014 Mar 25.
Khellaf M, Quantin C, d'Athis P, Fassa M, Jooste V, Hervieu M, Giroud M, Bejot Y. Age-period-cohort analysis of stroke incidence in Dijon from 1985 to 2005. Stroke. 2010 Dec;41(12):2762-7. doi: 10.1161/STROKEAHA.110.592147. Epub 2010 Nov 11.
Bejot Y, Delpont B, Giroud M. Rising Stroke Incidence in Young Adults: More Epidemiological Evidence, More Questions to Be Answered. J Am Heart Assoc. 2016 May 11;5(5):e003661. doi: 10.1161/JAHA.116.003661. No abstract available.
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.
Nichols-Larsen DS, Clark PC, Zeringue A, Greenspan A, Blanton S. Factors influencing stroke survivors' quality of life during subacute recovery. Stroke. 2005 Jul;36(7):1480-4. doi: 10.1161/01.STR.0000170706.13595.4f. Epub 2005 Jun 9.
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.
Sergi F, Krebs HI, Groissier B, Rykman A, Guglielmelli E, Volpe BT, Schaechter JD. Predicting efficacy of robot-aided rehabilitation in chronic stroke patients using an MRI-compatible robotic device. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:7470-3. doi: 10.1109/IEMBS.2011.6091843.
Dodakian L, Sharp KG, See J, Abidi NS, Mai K, Fling BW, Le VH, Cramer SC. Targeted engagement of a dorsal premotor circuit in the treatment of post-stroke paresis. NeuroRehabilitation. 2013;33(1):13-24. doi: 10.3233/NRE-130923.
Ang KK, Chua KS, Phua KS, Wang C, Chin ZY, Kuah CW, Low W, Guan C. A Randomized Controlled Trial of EEG-Based Motor Imagery Brain-Computer Interface Robotic Rehabilitation for Stroke. Clin EEG Neurosci. 2015 Oct;46(4):310-20. doi: 10.1177/1550059414522229. Epub 2014 Apr 21.
Ang KK, Guan C, Phua KS, Wang C, Zhao L, Teo WP, Chen C, Ng YS, Chew E. Facilitating effects of transcranial direct current stimulation on motor imagery brain-computer interface with robotic feedback for stroke rehabilitation. Arch Phys Med Rehabil. 2015 Mar;96(3 Suppl):S79-87. doi: 10.1016/j.apmr.2014.08.008.
Calabro RS, Russo M, Naro A, Milardi D, Balletta T, Leo A, Filoni S, Bramanti P. Who May Benefit From Armeo Power Treatment? A Neurophysiological Approach to Predict Neurorehabilitation Outcomes. PM R. 2016 Oct;8(10):971-978. doi: 10.1016/j.pmrj.2016.02.004. Epub 2016 Feb 20.
Scano A, Chiavenna A, Malosio M, Molinari Tosatti L, Molteni F. Robotic Assistance for Upper Limbs May Induce Slight Changes in Motor Modules Compared With Free Movements in Stroke Survivors: A Cluster-Based Muscle Synergy Analysis. Front Hum Neurosci. 2018 Aug 15;12:290. doi: 10.3389/fnhum.2018.00290. eCollection 2018.
Gandolfi M, Vale N, Dimitrova EK, Mazzoleni S, Battini E, Filippetti M, Picelli A, Santamato A, Gravina M, Saltuari L, Smania N. Effectiveness of Robot-Assisted Upper Limb Training on Spasticity, Function and Muscle Activity in Chronic Stroke Patients Treated With Botulinum Toxin: A Randomized Single-Blinded Controlled Trial. Front Neurol. 2019 Jan 31;10:41. doi: 10.3389/fneur.2019.00041. eCollection 2019.
Corona F, Gervasoni E, Coghe G, Cocco E, Ferrarin M, Pau M, Cattaneo D. Validation of the Arm Profile Score in assessing upper limb functional impairments in people with multiple sclerosis. Clin Biomech (Bristol). 2018 Jan;51:45-50. doi: 10.1016/j.clinbiomech.2017.11.010. Epub 2017 Nov 22.
Liu L, Miguel Cruz A, Rios Rincon A, Buttar V, Ranson Q, Goertzen D. What factors determine therapists' acceptance of new technologies for rehabilitation - a study using the Unified Theory of Acceptance and Use of Technology (UTAUT). Disabil Rehabil. 2015;37(5):447-55. doi: 10.3109/09638288.2014.923529. Epub 2014 Jun 5.
Pournajaf S, Morone G, Straudi S, Goffredo M, Leo MR, Calabro RS, Felzani G, Paolucci S, Filoni S, Santamato A, Franceschini M, The Italian PowerUPS-Rehab Study Group. Neurophysiological and Clinical Effects of Upper Limb Robot-Assisted Rehabilitation on Motor Recovery in Patients with Subacute Stroke: A Multicenter Randomized Controlled Trial Study Protocol. Brain Sci. 2023 Apr 21;13(4):700. doi: 10.3390/brainsci13040700.
Other Identifiers
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RP 20/08
Identifier Type: -
Identifier Source: org_study_id