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ACTIVE NOT RECRUITING
NCT04697368
NA

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

Sponsor: IRCCS San Raffaele Roma

View on ClinicalTrials.gov

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.

Official title: A Randomized Controlled Multicenter Study on the Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke.

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2020-12-28

Completion Date

2025-12-24

Last Updated

2025-12-18

Healthy Volunteers

No

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.

Locations (7)

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