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NCT Number: NCT07280884

Effect of Luna EMG Robotic Therapy on Physiotherapy Outcomes 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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Gait Disorders Hemiparesis Mobility Limitation Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

65 year–86 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Non-Public Health Care Center "Rehstab" (NZOZ "RehStab")

Limanowa, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Luna EMG Robotic Training

Device

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.

Conventional physiotherapy

Procedure

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

University School of Physical Education, Krakow, Poland

Other

Collaborators

  • Andrzej Frycz Modrzewski Krakow University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 12, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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