Effects of Bilateral Upper Limb Robot-assisted Rehabilitation on Motor Recovery in Patients With Subacute Stroke: an Italian Multicenter Randomized Controlled Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to study the clinical effects of a robotic rehabilitation treatment through a bilateral exoskeleton (Bilateral Robot-Assisted Therapy-BRAT) during standard rehabilitation, on motor recovery, compared to conventional arm re-education in people suffering from stroke in the subacute phase. The main question it aims to answer is what the effectiveness of Bilateral Robot-Assisted Therapy (BRAT) is in rehabilitating the upper limb in individuals with subacute stroke compared to conventional rehabilitation treatment in terms of motor function improvement as measured by the Fugl-Meyer Assessment - Upper Limb (FMA-UL), motor domain. Researchers will compare two groups (Experimental Group - EG and Control Group - CG) to see if the BRAT is more effective than conventional rehabilitation treatment in terms of motor recovery. Participants will be randomly assigned to one of the two treatment groups (EG or CG) and will be clinically and instrumentally evaluated at baseline (T0) and at the end of treatment (T1). EG, in addition to the standard rehabilitation treatment, will perform a 45-minute session of BRAT per day through the Arm Light Exoskeleton Hybrid (Alex RS - Wearable Robotics) robotic system. The CG, in addition to the standard routine rehabilitation treatment, will follow a conventional rehabilitation of the upper limbs without the use of technological devices. Finally, a telephone follow-up is scheduled three months after the end of the treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Both sexes;

• Age \>18 years;

• Unilateral hemipyramidal syndrome as demonstrated by a brain CT or MRI;

• Distance from acute event \< 6 months;

• Modified Ashworth Scale (MAS) of shoulder, elbow, and wrist \<3;

• Ability to understand and sign the informed consent for the study;

• Ability to perform the study procedures.

Locations
Other Locations
Italy
San Raffaele Cassino
NOT_YET_RECRUITING
Cassino
IRCCS San Raffaele Roma
RECRUITING
Rome
San Raffaele Sulmona
NOT_YET_RECRUITING
Sulmona
Contact Information
Primary
Dr. Sanaz Pournajaf, DPT
sanaz.pournajaf@sanraffaele.it
+39-06-52252405
Backup
Dr. Elena Sofia Cocco, Bioengineer
elenasofia.cocco@sanraffaele.it
Time Frame
Start Date: 2024-05-19
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 70
Treatments
Experimental: Experimental Group (EG)
The experimental group (EG), in addition to the standard rehabilitation treatment, will perform one Bilateral Robot-Assisted Therapy-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. The device that will be used have the CE (European Conformity) marking.
Active_comparator: Control Group (CG)
The control group (CG), 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. 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.
Related Therapeutic Areas
Sponsors
Leads: IRCCS San Raffaele Roma
Collaborators: Ministry of Health, Italy

This content was sourced from clinicaltrials.gov