The Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke. (PowerUPS-REHAB)

IRCCS San Raffaele Roma

Status: Active, not recruiting

Conditions: Upper Extremity Paresis; Stroke

Treatments: Device: Exoskeleton-Assisted Upper Limb Rehabilitation; Other: Traditional Upper Limb Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04697368

RP 20/08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Experimental Group (EG)

Experimental group

Description:

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.

Treatment:

Device: Exoskeleton-Assisted Upper Limb Rehabilitation

Control Group (CG)

Active Comparator group

Description:

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.

Treatment:

Other: Traditional Upper Limb Rehabilitation