Bilateral Robot-assisted Upper Extremity Rehabilitation on Motor Recovery in People With Subacute Stroke

NARecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

May 19, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
StrokeSabacute Stroke
Interventions
DEVICE

Experimental

The experimental group (EG), in addition to the standard rehabilitation treatment, will perform one upper limb BRAT session per day through the Arm Light Exoskeleton Hybrid (Alex RS - Wearable Robotics) robotic system.. Each participant will perform a total of 16+/-3 treatment sessions with a frequency of 4 times a week for 4 consecutive weeks. During the first session, the device should be adjusted according to the patient's bilateral size and suspension angle. The selection of personalized exercises will be based on each patient's motor skills and the difficulty can be gradually increased during the treatment period. These modalities are shown to the patient with visual and motor feedback (force feedback). The duration of the single rehabilitation treatment is 45 minutes, of which 5 minutes are used for setting up the device, 10 minutes for assembly/disassembly, 10 minutes for unilateral treatment with the affected upper limb and 20 minutes for bilateral treatment.

OTHER

Control

The control group (GC), in addition to the standard routine rehabilitation treatment, will follow 45 minutes of conventional rehabilitation of the upper limbs without the use of technological devices. Each participant will perform a total of 16+/-3 conventional upper limb treatment sessions with a frequency of 4 times a week for 4 weeks. The motor exercises will concern the rehabilitation of the upper limb and will be performed with a therapist who will personalize the treatment based on the clinical characteristics and needs of the patient. Specifically, the treatment of the upper limb will be characterized by motor exercises (shoulder, elbow, wrist and hand), coordination and manual dexterity. Each session will consist of passive, active-assisted and active exercises.

Trial Locations (3)

67039

NOT_YET_RECRUITING

San Raffaele Sulmona, Sulmona

03043

NOT_YET_RECRUITING

San Raffaele Cassino, Cassino

00166

RECRUITING

IRCCS San Raffaele Roma, Rome

All Listed Sponsors
collaborator

Ministry of Health, Italy

OTHER_GOV

lead

IRCCS San Raffaele Roma

OTHER