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

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

Interventions

DEVICE

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).

OTHER

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.

Sponsors & Collaborators

• Università degli Studi di Ferrara

  collaborator OTHER

• Fondazione Gli Angeli di Padre Pio

  collaborator UNKNOWN

• Azienda Ospedaliero, Universitaria Ospedali Riuniti

  collaborator OTHER

• IRCCS Centro Neurolesi Bonino Pulejo

  collaborator OTHER

• I.R.C.C.S. Fondazione Santa Lucia

  collaborator OTHER

• Presidio Ospedaliero Accreditato Villa Bellombra S.p.A

  collaborator UNKNOWN

• Ministry of Health, Italy

  collaborator OTHER_GOV

• IRCCS San Raffaele Roma

  lead OTHER

Principal Investigators

• Marco Franceschini, Prof. · IRCCS San Raffaele Pisana

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-28

Primary Completion

2025-03-01

Completion

2025-12-24

Countries

• Italy

Study Locations