Robotic Rehabilitation for Stroke
(GLORIA Trial)
Trial Summary
What is the purpose of this trial?
This multicenter international randomized controlled trial (RCT) evaluates the effectiveness of the Gloreha Sinfonia® robotic exoskeleton for upper limb rehabilitation in individuals with subacute post-stroke paresis. The study aims to determine whether robotic-assisted therapy improves voluntary motor control and coordination more effectively than conventional rehabilitation, as measured by the Fugl-Meyer Assessment (FMA) for the upper limb (motor component). Participants will be randomly assigned to one of two groups: * Experimental Group (EG): Robotic-assisted upper limb rehabilitation combined with conventional therapy. * Control Group (CG): Conventional therapy alone including upper limb rehabilitation. Clinical assessments will be conducted at baseline (T1), post-treatment (T2), and at a 3-month follow-up (T3) using remotely administered scales. Secondary objectives include evaluating improvements in muscle strength, range of motion, eye-hand coordination, manual dexterity, and functional independence. The study will also assess prognostic factors influencing response to robotic therapy, patient satisfaction, and potential adverse events.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you have received a botulinum toxin injection in the affected upper limb within the last 60 days or plan to during the study, you would not be eligible to participate.
What data supports the effectiveness of the treatment Gloreha Sinfonia® for stroke rehabilitation?
Research shows that robotic therapy can improve motor function in stroke patients, with benefits lasting beyond the typical recovery period. Studies on similar robotic devices have demonstrated that patients receiving robot-assisted training alongside traditional therapy achieve better motor function than those without robotic assistance.12345
How does the Gloreha Sinfonia® treatment differ from other stroke rehabilitation treatments?
The Gloreha Sinfonia® treatment is unique because it uses a robotic glove to assist with hand rehabilitation, focusing on improving motor function and reducing spasticity (muscle stiffness) in stroke patients. This approach is different from traditional therapies as it provides both active-assisted and passive robotic treatments, enhancing muscle blood flow and oxygen supply, which are not typically addressed by standard rehabilitation methods.678910
Research Team
Sanaz Pournajaf, DPT, PhD
Principal Investigator
IRCCS San Raffaele Roma
Eligibility Criteria
This trial is for individuals who have had a stroke recently and are experiencing weakness or paralysis in their arms. They should be stable enough to participate in rehabilitation therapy but haven't fully recovered their arm functions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either robotic-assisted upper limb rehabilitation combined with conventional therapy or conventional therapy alone for 18±3 sessions over approximately 5 weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment through clinical assessments conducted at a 3-month follow-up.
Treatment Details
Interventions
- Gloreha Sinfonia®
Find a Clinic Near You
Who Is Running the Clinical Trial?
IRCCS San Raffaele Roma
Lead Sponsor