NCT07280884

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: University School of Physical Education, Krakow, Poland · Academic / Other
• Sex: All
• Age: 65 Years – 86 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ischemic Stroke
• Hemiparesis
• Gait Disorders

Interventions

Type	Name	Description
DEVICE	Luna EMG Robotic Training	Therapy utilizing the Luna EMG robot (EgzoTech, Gliwice, Poland) performed 3 times a week for 20 minutes over 4 weeks. The training utilizes reactive electromyography to capture muscle signals and facilitate movement. The session protocol includes: Reactive EMG Trigger \& Hold (Knee Extension) - 5 mins. Continuous Passive Motion (CPM) - 1 min. Reactive EMG Trigger \& Hold (Knee Flexion) - 5 mins. Continuous Passive Motion (CPM) - 1 min. EMG Biofeedback (Isometric exercises for knee extensors and flexors) - 8 mins.
PROCEDURE	Conventional Physiotherapy	Standard neurological rehabilitation program conducted 2 hours daily, 6 times a week for 4 weeks. The program includes trunk stabilization, gait re-education (PNF method), manual dexterity exercises, and balance/coordination training. For the Control Group: During the time corresponding to robotic training, patients performed active resistance exercises for the lower limb for 20 minutes.

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2025-12-12
• Last updated: 2025-12-12

Locations

1 site across 1 country: Poland