StrokeNCT07002463
"Comparison of Therapist-Led and Robot-Assisted Arm Therapy in Subacute Stroke Rehabilitation"
A study testing Luna EMG and Therapist-assisted upper limb training in people with Stroke and Hemiparesis, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Hemiparesis, Muscle Spasticity
- What is being tested?
- Luna EMG and Therapist-assisted upper limb training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePoland
- Study dates
- 3 Apr 2023to 4 Mar 2024
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Lower Silesian Specialist Hospital T. Marciniak - Emergency Medicine Center
Wroclaw, 54-049
About this study
Official 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"
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.
Read the detailed description
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.
- Being tested
- Luna EMG, Therapist-assisted upper limb training
- Medical subject headings
- Stroke, Paresis, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luna EMGDevice
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 trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted training (Luna EMG) | Experimental | A robotic rehabilitation device using EMG-triggered movement assistance for upper limb recovery after stroke. Receives: Device: Luna EMG |
| Therapist-assisted training | Active comparator | A physiotherapist assists the participant in performing 4 specific upper limb movements (50 repetitions each), matching the robotic training protocol. Receives: Behavioral: Therapist-assisted upper limb training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE) motor score (0-66)
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.
Measured: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
Secondary outcomes (10)
Change in total Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score (0-126)
The total score includes motor, sensory, and joint-related components and provides a comprehensive assessment of upper limb impairment. Higher scores indicate better function.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline, Week 3, Week 6, and 3 weeks after therapy completion (Rest and activity)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start3 Apr 2023
- Primary completion12 Feb 2024
- Study completion4 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- Participants are randomly assigned to one of two parallel groups: (1) robot-assisted upper limb rehabilitation using Luna EMG or (2) therapist-assisted upper limb rehabilitation. Both groups also receive the same standard rehabilitation program. Randomization was performed using simple urn-based drawing by an individual independent of the study team. An additional balancing step was applied post-assignment to ensure equal group sizes. Interventions are delivered in parallel over 6 weeks, 5 days per week.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denis Moskiewicz, Wroclaw University of Health and Sport Sciences
- Investigators
- Denis Moskiewicz, M.Sc., Study chair, Department of Physiotherapy, Wroclaw University of Health and Sport Sciences, 51-612 Wrocław, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002463
- Sponsor's protocol ID
- LUNA-AWF-2025-01
- Status last verified
- May 2025
- First submitted
- 22 May 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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"
- ClinicalTrials.gov ID
- NCT07002463
- Acronym / sponsor ID
- LUNA-AWF-2025-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 12 Feb 2024 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 3 Jun 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two parallel groups: (1) robot-assisted upper limb rehabilitation using Luna EMG or (2) therapist-assisted upper limb rehabilitation. Both groups also receive the same standard rehabilitation program. Randomization was performed using simple urn-based drawing by an individual independent of the study team. An additional balancing step was applied post-assignment to ensure equal group sizes. Interventions are delivered in parallel over 6 weeks, 5 days per week.
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted training (Luna EMG) | Experimental | Device: Luna EMGA robotic rehabilitation device using EMG-triggered movement assistance for upper limb recovery after stroke. |
| Therapist-assisted training | Active comparator | Behavioral: Therapist-assisted upper limb trainingA physiotherapist assists the participant in performing 4 specific upper limb movements (50 repetitions each), matching the robotic training protocol. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 EMGParticipants 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. | Device | Robot-assisted training (Luna EMG) |
| Therapist-assisted upper limb trainingParticipants 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. | Behavioural | Therapist-assisted training |
Primary outcome
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.
10 secondary outcomes
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
Box and Blocks Test (B&BT)
Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
EQ-5D-5L
Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
Muscle Tone - Modified Ashworth Scale (MAS)
Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
Muscle Oscillation Frequency Measured by MyotonPRO
Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
Muscle Stiffness Measured by MyotonPRO
Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
Muscle Elasticity Measured by MyotonPRO
Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
Muscle Relaxation Time Measured by MyotonPRO
Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
Muscle Creep Measured by MyotonPRO
Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion
Pain Intensity (NRS 0-10)
Time frame: Baseline, Week 3, Week 6, and 3 weeks after therapy completion (Rest and activity)
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 23 Apr 2026.
- Individual participant dataSharing planned: Yes
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Denis Moskiewicz, M.Sc. study chair
Department of Physiotherapy, Wroclaw University of Health and Sport Sciences, 51-612 Wrocław, Poland
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 and Therapist-assisted upper limb training in people with Stroke and Hemiparesis, run by Wroclaw University of Health and Sport Sciences 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 6 inclusion and 5 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 23 Apr 2026. 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 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). 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 23 Apr 2026.