Ischemic StrokeNCT07280884
Effect of Luna EMG Robotic Therapy on Physiotherapy Outcomes in Post-Ischemic Stroke Patients
A study testing Luna EMG Robotic Training and Conventional Physiotherapy in people with Ischemic Stroke and Hemiparesis, run by University School of Physical Education, Krakow, Poland at 1 site in Poland.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 to 86 years
- Conditions the study is for
- Ischemic Stroke, Hemiparesis, Gait Disorders
- What is being tested?
- Luna EMG Robotic Training and Conventional Physiotherapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePoland
- Study dates
- 1 May 2022to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 86 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Cognitive function sufficient to understand instructions and participate in the study
- Stable clinical status
- Provided written informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Luna EMG Robotic Training, Conventional Physiotherapy
- Keywords
- Physiotherapy, Robotic rehabilitation, Luna EMG
- Medical subject headings
- Ischemic Stroke, Paresis, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luna EMG Robotic TrainingDevice
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 PhysiotherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: Procedure: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and at 4 weeks (post-intervention)
Secondary outcomes (2)
Change in Bioelectrical Activity of the Rectus Femoris Muscle
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).
Measured: Baseline and at 4 weeks (post-intervention)
Change in Bioelectrical Activity of the Biceps Femoris Muscle
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).
Measured: Baseline and at 4 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start1 May 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University School of Physical Education, Krakow, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Andrzej Frycz Modrzewski Krakow University
- Responsible party
- Sponsor
- Investigators
- Iwona Sihinkiewicz, PhD, Principal investigator, Andrzej Frycz Modrzewski Krakow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280884
- Sponsor's protocol ID
- 153/MN/IRK/2022
- Status last verified
- Nov 2025
- First submitted
- 1 Dec 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hemiparesis Side on Physiotherapy Outcomes Using the Luna EMG in Post-Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT07280884
- Acronym / sponsor ID
- 153/MN/IRK/2022
- Conditions
- Ischemic Stroke, Hemiparesis, Gait Disorders
- Keywords
- Physiotherapy, Robotic rehabilitation, Luna EMG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University School of Physical Education, Krakow, PolandUniversity, hospital or other
- Collaborators
- Andrzej Frycz Modrzewski Krakow University
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (Luna EMG) | Experimental | Device: Luna EMG Robotic Training, Procedure: Conventional Physiotherapy20 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. |
| Control Group (Standard Therapy) | Active comparator | Procedure: Conventional PhysiotherapyActive 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) |
Who may qualify
- Ages
- 65 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Luna EMG Robotic TrainingTherapy 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. | Device | Experimental Group (Luna EMG) |
| Conventional PhysiotherapyStandard 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. | Procedure or surgery | Control Group (Standard Therapy), Experimental Group (Luna EMG) |
Primary outcome
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.
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.
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.
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.
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.
2 secondary outcomes
Change in Bioelectrical Activity of the Rectus Femoris Muscle
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iwona Sihinkiewicz, PhD principal investigator
Andrzej Frycz Modrzewski Krakow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Luna EMG Robotic Training and Conventional Physiotherapy in people with Ischemic Stroke and Hemiparesis, run by University School of Physical Education, Krakow, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Static and Dynamic Balance (Berg Balance Scale - BBS) (time frame: Baseline and at 4 weeks (post-intervention)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.