Evaluating Robotic-Assisted Therapy Using Gloreha Sinfonia for Upper Limb Recovery After Subacute Stroke

What this Trial Is About

Researchers are evaluating the effectiveness of the Gloreha Sinfonia4 robotic exoskeleton for upper limb rehabilitation in people who have experienced subacute post-stroke paresis. This international multicenter randomized controlled trial aims to compare robotic-assisted therapy combined with conventional rehabilitation against conventional therapy alone. The main goal is to see if robotic therapy improves voluntary motor control and coordination better, measured by the Fugl-Meyer Assessment for the upper limb motor function. Secondary goals include assessing muscle strength, range of motion, coordination, manual skill, independence in daily activities, patient satisfaction, and any adverse events. Participants are randomly assigned to one of two groups the Experimental Group EG receives robotic-assisted upper limb rehabilitation along with conventional physical and occupational therapy, while the Control Group CG receives only conventional therapy. Both groups undergo 18 sessions, 3 to 5 times per week, with each daily session lasting 90 minutes. The robotic therapy in the EG progresses through passive, assisted, and active mobilization modes over five weeks, with personalized adjustments based on motor ability. Conventional therapy includes tailored motor exercises for shoulder, elbow, wrist, and hand. The study includes a recruitment and treatment phase followed by a 3-month follow-up period. Participants will have clinical assessments at baseline, after treatment around 35 days, and at 3 months follow-up around 125 days. Evaluations include motor function scales, muscle strength, spasticity, pain, dexterity tests, independence measures, and patient satisfaction questionnaires. Follow-up assessments may be conducted in person or by phone using remote scales. Data collection is anonymized and securely stored. Researchers will analyze the clinical and demographic data to understand treatment effects, patient response factors, and rehabilitation outcomes over the 36-month study duration.

Robotic Rehabilitation of the Upper Limb in Subacute Stroke