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

NCT07280884 | Completed

• 1 other identifier: 153/MN/IRK/2022
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke; Hemiparesis; Gait Disorders

Keywords

Physiotherapy; Robotic rehabilitation; Luna EMG

Outcome Measures

Primary Outcomes (5)

• Change in Static and Dynamic Balance (Berg Balance Scale - BBS)

  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)

  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)

  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)

  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)

  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 Outcomes (2)

• Change in Bioelectrical Activity of the Rectus Femoris Muscle

  Baseline and at 4 weeks (post-intervention)

• Change in Bioelectrical Activity of the Biceps Femoris Muscle

  Baseline and at 4 weeks (post-intervention)

Study Arms (2)

Experimental Group (Luna EMG)

EXPERIMENTAL

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; Procedure: Conventional Physiotherapy

Control Group (Standard Therapy)

ACTIVE COMPARATOR

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

Interventions

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.

Experimental Group (Luna EMG)

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.

Control Group (Standard Therapy); Experimental Group (Luna EMG)

Eligibility Criteria

• Age: 65 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University School of Physical Education, Krakow, Poland: lead
• Andrzej Frycz Modrzewski Krakow University: collaborator

Study Sites (1)

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

Limanowa, Poland

Location

MeSH Terms

Conditions

Ischemic Stroke; Paresis; Mobility Limitation

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Iwona Sihinkiewicz, PhD

  Andrzej Frycz Modrzewski Krakow University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: May 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 12, 2025

Record last verified: 2025-11

Locations

PL (1)