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

University School of Physical Education, Krakow, Poland

Status: Completed

Conditions: Ischemic Stroke; Gait Disorders; Hemiparesis

Treatments: Device: Luna EMG Robotic Training; Procedure: Conventional Physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07280884

153/MN/IRK/2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 65 to 86 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Experimental Group (Luna EMG)

Experimental group

Description:

20 minutes of training using Luna EMG (reactive EMG-controlled knee extensions/flexions, CPM exercises, EMG biofeedback isometric exercises), 3 times a week for 4 weeks. PLUS Standard Rehabilitation.

Treatment:

Procedure: Conventional Physiotherapy

Device: Luna EMG Robotic Training

Control Group (Standard Therapy)

Active Comparator group

Description:

Active resistance exercises for 20 minutes (mirroring the time of the experimental group), 3 times a week, alongside the standard rehabilitation program (2 hours/day total)

Treatment:

Procedure: Conventional Physiotherapy