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Robotic Rehabilitation of the Upper Limb in Subacute Stroke

Study acronym: GLORIA
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Study sites: 20 to 21v4
  2. Notable Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 20 of 20 sites
    v3
  3. Notable Primary endpoint revised
    • Interventions: Control Group (CG) (Other), Experimental Group (EG) (Device) to Control Group (CG) (Other), Robotic Assisted Upper Limb Rehabilitation (Device)
    • Secondary endpoints revised (11)
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06839482
Lead Sponsor IRCCS San Raffaele Roma
Conditions
(from sponsor)
Stroke
Related terms Stroke
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov