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NCT Number: NCT07002463

"Comparison of Therapist-Led and Robot-Assisted Arm Therapy in Subacute Stroke Rehabilitation"

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiparesis Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Subacute Stroke Upper Extremity Dysfunction Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lower Silesian Specialist Hospital T. Marciniak - Emergency Medicine Center

Wroclaw, 54-049, Poland

About this study

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 58 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-90
  • First-ever ischemic or hemorrhagic stroke within 6 weeks prior to enrollment
  • Stable medical condition
  • Fugl-Meyer Assessment for Upper Extremity (FMA-UE) ≤ 94
  • Mini-Mental State Examination (MMSE) ≥ 23
  • Signed informed consent

Exclusion criteria

  • Fixed contractures in upper limb
  • MAS ≥ 3 in any upper limb muscle
  • Severe vision/hearing problems
  • Severe dysphagia or respiratory issues
  • Myasthenia or myasthenic syndrome

Treatment and study plan

Luna EMG

Device

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.

Therapist-assisted upper limb training

Behavioral

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.

Primary outcomes

  1. Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE) motor score (0-66)

    Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion

    The motor subscale of the FMA-UE was used to assess upper limb motor function. Higher scores indicate better motor performance. The motor score was predefined as the primary outcome prior to data analysis.

Secondary outcomes

  1. Change in total Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score (0-126)

    Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion

    The total score includes motor, sensory, and joint-related components and provides a comprehensive assessment of upper limb impairment. Higher scores indicate better function.

  2. Box and Blocks Test (B&BT)

    Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion

    Measures gross manual dexterity by counting the number of blocks transferred in 60 seconds.

    Higher scores indicate better manual dexterity.

  3. EQ-5D-5L

    Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion

    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.

  4. Muscle Tone - Modified Ashworth Scale (MAS)

    Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion

    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).

  5. Muscle Oscillation Frequency Measured by MyotonPRO

    Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion

    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.

  6. Muscle Stiffness Measured by MyotonPRO

    Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion

    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.

  7. Muscle Elasticity Measured by MyotonPRO

    Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion

    Measurement of muscle elasticity (logarithmic decrement) in selected upper limb muscles using the MyotonPRO device. Lower values indicate more elastic (less stiff) muscle tissue.

  8. Muscle Relaxation Time Measured by MyotonPRO

    Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion

    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.

  9. Muscle Creep Measured by MyotonPRO

    Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion

    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.

  10. Pain Intensity (NRS 0-10)

    Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion (Rest and activity)

    Numeric pain rating scale (0 = no pain, 10 = worst imaginable pain).

Sponsors and collaborators

Lead sponsor

Wroclaw University of Health and Sport Sciences

Other

Registry information

Official study title

"Comparison of Outcomes of Physiotherapist- and Robot-Assisted Upper Limb Therapy and Their Association With Muscle Tone and Motor Function in Subacute Stroke Patients"

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 3, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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