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| Name | Class |
|---|---|
| Andrzej Frycz Modrzewski Krakow University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and at 4 weeks (post-intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iwona Sihinkiewicz, PhD | Andrzej Frycz Modrzewski Krakow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Non-Public Health Care Center "Rehstab" (NZOZ "RehStab") | Limanowa | Poland |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D010291 | Paresis |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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. |
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| 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). |
| Baseline and at 4 weeks (post-intervention) |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |