Clinical trial NCT04697368: The Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke.
Official title: A Randomized Controlled Multicenter Study on the Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Upper Extremity Paresis
Keywords: Stroke
Subacute
upper limb
motor function
robot-assisted rehabilitation
Armeo Power
exoskeleton
Fugle-Meyer Assessment
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
Collaborators: name: Università degli Studi di Ferrara
name: Fondazione Gli Angeli di Padre Pio
name: Azienda Ospedaliero, Universitaria Ospedali Riuniti
name: IRCCS Centro Neurolesi Bonino Pulejo
name: I.R.C.C.S. Fondazione Santa Lucia
name: Presidio Ospedaliero Accreditato Villa Bellombra S.p.A
name: Ministry of Health, Italy
First posted: 2021-01-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a multicentre, single-blind (evaluator) randomized controlled trial (RCT).
Primary purpose: TREATMENT

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.

Detailed description: Stroke is the most common cause of complex adult disability in high-income countries \[1\]. Loss of arm function affects 69% of people who have a stroke \[2\]. Only 12% of people with arm weakness at the onset of stroke make a full recovery \[3\]. Improving arm function has been identified as a research priority by stroke survivors, carers, and health professionals who report that current rehabilitation pays insufficient attention to arm recovery \[4\].

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Change in Fugl-Meyer Assessment of Upper Extremities motor recovery after stroke -FMA
timeFrame: 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:
measure: Change in Modified Ashworth Scale (shoulder, elbow, and wrist).
timeFrame: Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).
measure: Change in Box & Block Test
timeFrame: Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).
measure: Change in Nine Hole Peg Test
timeFrame: Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).
measure: Change in Frenchy Arm Test
timeFrame: Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).
measure: Change in modified Barthel Index
timeFrame: Session 1 (Baseline-day1, T0), Session 25 (end of treatment-day 35, T1) and a follow-up (6 months since the acute event T2).
measure: Change in Modified Rankin scale
timeFrame: 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:
measure: Instrumental assessment through the Armeo Power
timeFrame: Session 1 (Baseline-day1, T0) and session 25 (end of treatment-day 35, T1)
measure: Changes in muscles activity Surface electromyography (sEMG)
timeFrame: Session 1 (Baseline-day1, T0) and session 25 (end of treatment-day 35, T1)
measure: Kinematic changes
timeFrame: Session 1 (Baseline-day1, T0) and session 25 (end of treatment-day 35, T1)
measure: Neurophysiological changes through EEG
timeFrame: Session 1 (Baseline-day1, T0) and session 25 (end of treatment-day 35, T1)
Locations:
city: Bergamo
country: Italy
facility: HABILITA S.p.A
state: BG
city: Bologna
country: Italy
facility: Villa Bellombra
city: Ferrara
country: Italy
facility: Azienda Ospedaliero-Universitaria di Ferrara
city: Foggia
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti
city: Messina
country: Italy
facility: IRCCS Centro Neurolesi Bonino Pulejo
city: Roma
country: Italy
facility: IRCCS San Raffaele Pisana
city: Rome
country: Italy
facility: IRCCS fondazione Santa Lucia
city: San Giovanni Rotondo
country: Italy
facility: Fondazione "Gli Angeli di Padre Pio"
Study officials:
affiliation: IRCCS San Raffaele Pisana
name: Marco Franceschini, Prof.
role: PRINCIPAL_INVESTIGATOR
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