Effect of Luna EMG Robotic Therapy on Physiotherapy Outcomes in Post-Ischemic Stroke Patients

Effect of Hemiparesis Side on Physiotherapy Outcomes Using the Luna EMG in Post-Ischemic Stroke Patients

The study evaluates the effectiveness of the Luna EMG robotic system in the rehabilitation of patients after ischemic stroke. The main objective is to assess the impact of robotic-assisted training on gait speed, balance, and bioelectrical activity of the thigh muscles (rectus femoris and biceps femoris). The study also analyzes whether the side of hemiparesis (left vs. right) influences the outcomes of physiotherapy. Participants are randomly assigned to either an experimental group receiving robotic therapy combined with standard rehabilitation or a control group receiving standard rehabilitation alone.

This prospective, randomized clinical trial aims to determine the efficacy of Luna EMG-assisted training in post-stroke motor recovery. The study involves 62 patients aged 65-86 years recovering from ischemic stroke (4-15 weeks post-stroke).

Participants are randomized into two groups:

Experimental Group: Patients undergo a 4-week rehabilitation program consisting of standard physiotherapy (2 hours/day, 6 days/week) combined with robotic training using the Luna EMG device (20 minutes, 3 days/week). The robotic protocol includes reactive EMG-triggered exercises, continuous passive motion (CPM), and EMG biofeedback isometric exercises.

Control Group: Patients undergo the same standard physiotherapy program (2 hours/day, 6 days/week) but perform active resistance exercises instead of robotic training during the equivalent time slots.

The primary outcome measures include balance assessment (Timed Up and Go, Berg Balance Scale, Trunk Impairment Scale, Postural Assessment Scale for Stroke Patients) and gait speed (10-Meter Walk Test). Secondary outcomes involve the analysis of surface electromyography (sEMG) signals from the paretic lower limb muscles to evaluate changes in bioelectrical activity. The study specifically investigates comparative outcomes between patients with left-sided versus right-sided hemiparesis.

Inclusion Criteria:

• Diagnosis of primary ischemic stroke
• Time from stroke: 4 to 15 weeks
• Age between 65 and 86 years
• Limited or impaired lower limb function
• Ability to walk 10 meters independently or with orthopedic assistance
• Muscle strength of at least -3 on the modified Medical Research Council (MRC) scale
• Cognitive function sufficient to understand instructions and participate in the study
• Stable clinical status
• Provided written informed consent

Exclusion Criteria:

• Hemorrhagic stroke or stroke in the posterior cerebral circulation
• Lower limb spasticity greater than 1+ on the modified Ashworth Scale (MAS)
• Functional limitations preventing the completion of selected tests
• Recent orthopedic injuries affecting balance
• Prior lower limb surgery
• Sensory aphasia
• Coexisting neurological disorders (e.g., Parkinson's disease, Huntington's disease)
• Lack of patient cooperation or refusal to consent