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

NCT ID: NCT07280884

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2022-12-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Luna EMG Robotic Training

Intervention Type: 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

Intervention Type: 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)

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)

Group Type: ACTIVE_COMPARATOR

Conventional Physiotherapy

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 86 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Andrzej Frycz Modrzewski Krakow University

OTHER

Sponsor Role: collaborator

University School of Physical Education, Krakow, Poland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Iwona Sihinkiewicz, PhD

Role: PRINCIPAL_INVESTIGATOR

Andrzej Frycz Modrzewski Krakow University

Locations

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

Limanowa, , Poland

Countries

Poland

Other Identifiers

153/MN/IRK/2022

Identifier Type: -

Identifier Source: org_study_id