This study aims to compare the outcomes of upper limb motor therapy conducted by a physiotherapist with robot-assisted therapy using the Luna EMG device in patients in the subacute phase after stroke. Additionally, the study will examine the correlation between changes in muscle tone and motor function improvement. The randomized controlled trial will be conducted at the Rehabilitation Department of the T. Marciniak Lower Silesian Specialist Hospital in Wrocław, Poland. Two groups (robot-assisted vs. conventional therapy) will perform identical sets of movements with matched repetition counts over a 6-week therapy period. Functional improvement will be assessed using Fugl-Meyer Upper Extremity Assessment (FMA-UE), Box and Block Test (B\&BT), EQ-5D-5L, and MyotonPro measurements.
Stroke often leads to upper limb motor impairment, spasticity, and reduced independence. Robot-assisted rehabilitation, including devices like Luna EMG, may increase therapy intensity and patient motivation through feedback and movement intention detection via EMG signals. This interventional study includes 50 participants post-stroke, randomly assigned to either robot-assisted therapy (Luna EMG) or conventional physiotherapist-led therapy. Both groups receive standard rehabilitation (75 minutes/day), with an additional 45-minute targeted upper limb training session. Sessions are conducted 5 days a week for 6 weeks. Muscle tone will be assessed using the Modified Ashworth Scale and biomechanical parameters (stiffness, oscillation) with MyotonPro. Motor performance will be evaluated using the Fugl-Meyer Assessment (FMA-UE) and the Box and Block Test (B\&BT). Quality of life and pain perception will also be measured using the EQ-5D-5L and a numeric rating scale (NRS). Outcome measures will be collected at baseline, after 3 weeks, after 6 weeks of therapy, and 3 weeks post-intervention to evaluate both immediate and short-term effects of the intervention. This study seeks to identify whether robotic rehabilitation offers measurable advantages over traditional methods in early post-stroke recovery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
58
Participants receive additional upper limb rehabilitation using the Luna EMG robotic system. Each session includes 4 EMG-triggered exercises (shoulder flexion, external rotation, elbow extension, and forearm supination), with 50 repetitions per movement. The intervention is delivered 5 days per week for 6 weeks alongside a standard rehabilitation program.
Participants receive additional upper limb rehabilitation with a physiotherapist performing assisted movements equivalent to the robotic training protocol. Each session includes 4 assisted exercises (shoulder flexion, external rotation, elbow extension, and forearm supination), with 50 repetitions per movement. The intervention is delivered 5 days per week for 6 weeks alongside a standard rehabilitation program.
Lower Silesian Specialist Hospital T. Marciniak - Emergency Medicine Center
Wroclaw, Poland
Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Functional motor recovery of the affected upper limb, scored 0-66 (or 94, depending on version used). Higher scores indicate better function.
Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
Box and Blocks Test (B&BT)
Measures gross manual dexterity by counting the number of blocks transferred in 60 seconds. Higher scores indicate better manual dexterity.
Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
EQ-5D-5L
Quality of life across 5 domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Scores are reported on a scale from 0 to 1, where 0 represents the worst possible health state and 1 represents the best possible health state. Higher scores indicate better quality of life.
Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
Muscle Tone - Modified Ashworth Scale (MAS)
Spasticity of upper limb muscles scored 0-4. It scores resistance during passive soft-tissue stretching on a scale from 0 to 4. The scale is as follows: 0 = No increase in muscle tone 1 = Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion 1+ = Slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout the remainder (less than half) of the range of motion 2 = More marked increase in muscle tone through most of the range of motion, but affected part(s) easily moved 3 = Considerable increase in muscle tone, passive movement difficult 4 = Affected part(s) rigid in flexion or extension Higher scores indicate greater spasticity (worse outcome).
Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
Muscle Oscillation Frequency Measured by MyotonPRO
Objective measurement of natural oscillation frequency (Hz) of selected upper limb muscles using the MyotonPRO device. This parameter reflects muscle tone and viscoelastic properties. Higher values indicate increased muscle tone.
Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
Muscle Stiffness Measured by MyotonPRO
Objective measurement of muscle stiffness (N/m) in selected upper limb muscles using the MyotonPRO device. Stiffness represents resistance to deformation. Higher values indicate greater muscle rigidity.
Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
Muscle Elasticity Measured by MyotonPRO
Measurement of muscle elasticity (logarithmic decrement) in selected upper limb muscles using the MyotonPRO device. Lower values indicate more elastic (less stiff) muscle tissue.
Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
Muscle Relaxation Time Measured by MyotonPRO
Measurement of muscle relaxation time (milliseconds) in selected upper limb muscles using the MyotonPRO device. This is the time taken for the muscle to return to its initial state after deformation. Shorter relaxation time suggests better muscle function.
Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
Muscle Creep Measured by MyotonPRO
Assessment of muscle creep (deformation over time under constant load) in selected upper limb muscles using the MyotonPRO device. Higher creep values indicate greater viscoelastic deformation.
Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
Pain Intensity (NRS 0-10)
Numeric pain rating scale (0 = no pain, 10 = worst imaginable pain).
Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion (Rest and activity)
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