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

December 1, 2025 updated by: University School of Physical Education, Krakow, Poland

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Limanowa, Poland
        • Non-Public Health Care Center "Rehstab" (NZOZ "RehStab")

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group (Luna EMG)
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.
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.
Active Comparator: Control Group (Standard Therapy)
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Static and Dynamic Balance (Berg Balance Scale - BBS)
Time Frame: Baseline and at 4 weeks (post-intervention)
The BBS is a 14-item objective measure that assesses static balance and fall risk in adult populations. Tasks include sitting to standing, standing unsupported, reaching, turning, etc. The score ranges from 0 to 56, where higher scores indicate better balance.
Baseline and at 4 weeks (post-intervention)
Change in Functional Mobility and Balance (Timed Up and Go Test - TUG)
Time Frame: Baseline and at 4 weeks (post-intervention)
The TUG test assesses mobility, balance, walking ability, and fall risk. The patient stands up from a chair, walks 3 meters, turns around, walks back, and sits down. The time taken to complete the task is measured in seconds. Lower time indicates better functional mobility.
Baseline and at 4 weeks (post-intervention)
Change in Trunk Control (Trunk Impairment Scale - TIS)
Time Frame: Baseline and at 4 weeks (post-intervention)
The TIS evaluates motor impairment of the trunk after stroke. It assesses static sitting balance, dynamic sitting balance, and coordination. Higher scores indicate better trunk control and stability.
Baseline and at 4 weeks (post-intervention)
Change in Postural Control (Postural Assessment Scale for Stroke Patients - PASS)
Time Frame: Baseline and at 4 weeks (post-intervention)
The PASS assesses postural control in patients after stroke. It measures the ability to maintain and change lying, sitting, and standing postures. Higher scores indicate better postural performance.
Baseline and at 4 weeks (post-intervention)
Change in Gait Speed (10-Meter Walk Test - 10MWT)
Time Frame: Baseline and at 4 weeks (post-intervention)
Assesses walking speed over a short distance. The patient walks 10 meters, and the time is measured for the intermediate 6 meters to allow for acceleration and deceleration. The result is calculated in meters per second (m/s). Higher speed indicates better gait performance.
Baseline and at 4 weeks (post-intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Bioelectrical Activity of the Rectus Femoris Muscle
Time Frame: Baseline and at 4 weeks (post-intervention)
Measured using surface electromyography (sEMG) with the Luna EMG system. The mean amplitude of the sEMG signal is recorded during active knee extension of the paretic limb to assess muscle activation. Measured in microvolts (µV).
Baseline and at 4 weeks (post-intervention)
Change in Bioelectrical Activity of the Biceps Femoris Muscle
Time Frame: Baseline and at 4 weeks (post-intervention)
Measured using surface electromyography (sEMG) with the Luna EMG system. The mean amplitude of the sEMG signal is recorded during active knee flexion of the paretic limb to assess muscle activation. Measured in microvolts (µV).
Baseline and at 4 weeks (post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University School of Physical Education, Krakow, Poland

Collaborators

Andrzej Frycz Modrzewski Krakow University

Investigators

  • Principal Investigator: Iwona Sihinkiewicz, PhD, Andrzej Frycz Modrzewski Krakow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 153/MN/IRK/2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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