The Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke.

NCT04697368 | Active Not Recruiting DMC

• 1 other identifier: RP 20/08
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 7

Brief Summary

Loss of arm function is a common and distressing consequence of stroke. Neurotechnology-aided rehabilitation could be a promising approach to accelerate the recovery of upper limb functional impairments. This multicentre randomized controlled trial is aimed at assessing the efficacy of robot-assisted upper limb rehabilitation in subjects with sub-acute stroke following a stroke, compared to the traditional upper limb rehabilitation.

Conditions

Stroke; Upper Extremity Paresis

Keywords

Stroke; Subacute; upper limb; motor function; robot-assisted rehabilitation; Armeo Power; exoskeleton; Fugle-Meyer Assessment

Outcome Measures

Primary Outcomes (1)

• Change in Fugl-Meyer Assessment of Upper Extremities motor recovery after stroke -FMA

  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. In this study, we will consider the motor performance items of Upper extremity (0-66), only.

  Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).

Secondary Outcomes (6)

• Change in Modified Ashworth Scale (shoulder, elbow, and wrist).

  Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).

• Change in Box & Block Test

  Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).

• Change in Nine Hole Peg Test

  Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).

• Change in Frenchy Arm Test

  Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).

• Change in modified Barthel Index

  Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).

Other Outcomes (4)

• Instrumental assessment through the Armeo Power

  Session 1 (Baseline-day1, T0) and session 25 (end of treatment-day 35, T1)

• Changes in muscles activity Surface electromyography (sEMG)

  Session 1 (Baseline-day1, T0) and session 25 (end of treatment-day 35, T1)

• Kinematic changes

  Session 1 (Baseline-day1, T0) and session 25 (end of treatment-day 35, T1)

Study Arms (2)

Experimental Group (EG)

EXPERIMENTAL

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.

Device: Exoskeleton-Assisted Upper Limb Rehabilitation

Control Group (CG)

ACTIVE COMPARATOR

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.

Other: Traditional Upper Limb Rehabilitation

Interventions

Exoskeleton-Assisted Upper Limb Rehabilitation DEVICE

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).

Also known as: Armro Power

Experimental Group (EG)

Traditional Upper Limb Rehabilitation OTHER

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.

Control Group (CG)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 85 years;
• 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.

You may not qualify if:

• unstable general clinical conditions;
• 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).

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead
• Fondazione Gli Angeli di Padre Pio: collaborator
• Azienda Ospedaliero, Universitaria Ospedali Riuniti: collaborator
• IRCCS Centro Neurolesi Bonino Pulejo: collaborator
• I.R.C.C.S. Fondazione Santa Lucia: collaborator
• Presidio Ospedaliero Accreditato Villa Bellombra S.p.A: collaborator
• Ministry of Health, Italy: collaborator
• Università degli Studi di Ferrara: collaborator

Study Sites (7)

Villa Bellombra

Bologna, Italy

Location

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, Italy

Location

Azienda Ospedaliero Universitaria Ospedali Riuniti

Foggia, Italy

Location

IRCCS Centro Neurolesi Bonino Pulejo

Messina, Italy

Location

IRCCS San Raffaele Pisana

Roma, 00163, Italy

Location

IRCCS fondazione Santa Lucia

Rome, Italy

Location

Fondazione "Gli Angeli di Padre Pio"

San Giovanni Rotondo, Italy

Location

Related Publications (18)

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• 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.

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• 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.

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• Morone G, Pournajaf S, Iosa M, Goffredo M, Leo MR, Paolucci S, Gatta MT, Santamato A, Straudi S, Calabro RS, Franceschini M; Italian PowerUPS-Rehab Study Group. Exoskeleton-Assisted Therapy Enhances Upper Limb Motor Recovery in Early Subacute Stroke: A Multicenter, Single-Blind Randomized Controlled Trial. Stroke. 2026 Mar 12. doi: 10.1161/STROKEAHA.125.052605. Online ahead of print.

  PMID: 41815092 DERIVED

• 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.

  PMID: 37190665 DERIVED

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Franceschini, Prof.

  IRCCS San Raffaele Pisana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blind to the study protocol.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a multicentre, single-blind (evaluator) randomized controlled trial (RCT).

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 6, 2021
• Study Start: December 28, 2020
• Primary Completion: March 1, 2025
• Study Completion: December 24, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Actual
• Access Criteria: Open Access

Locations

IT (7)