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The Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke.
Sponsor: IRCCS San Raffaele Roma
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
Conditions
Interventions
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).
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