StrokeLUNANCT04716829
LUNA-EMG to Enhance Motor Functions in Neurological Disorders
A study testing LUNA-EMG in people with Stroke, run by University of Liege at 1 site in Belgium.
Trial summary
The aim of the present study is to evaluate the effects of training performed with the LUNA-EMG system to enhance motor functions of the upper limb in stroke This is a randomized open-label trial. Patients will be randomized into the intervention group (LUNA-EMG) or in the control group (standard care). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- LUNA-EMG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2021to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult
- Having signed the informed consent
Who cannot join
- Acute pain syndrome
- Severe cognitive deficits
- Risk of fracture or unconsolidated fracture
- Rigid joints (spasticity, severe osteoarthritis and arthritis) or unstable joints
- Severe ataxia and apraxia
- Epilepsy
- Pacemakers and similar implants
- Insufficient skin conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Efficacy of the LUNA-EMG System on Motor Function in the Management of Neurological Disorders.
The aim of the present study is to evaluate the effects of training performed with the LUNA-EMG system to enhance motor functions of the upper limb in stroke This is a randomized open-label trial. Patients will be randomized into the intervention group (LUNA-EMG) or in the control group (standard care).
The effect of the training will be measured with the EMG, the upper limb motor function and the quality of life.
- Conditions
- Stroke
- Being tested
- LUNA-EMG
- Keywords
- stroke, EMG, rehabilitation, physiotherapy, occupational therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUNA-EMGDevice
The LUNA-EMG (Samcom) system is a robot that allows the evaluation of muscular strength through the recording of muscle activity (electromyography - EMG) in order to provide precise objective data on the patient's muscle function. In addition to the diagnostic aspect (evaluation of muscle strength, range of motion and proprioception), the LUNA-EMG robot allows the adaptation of movements during rehabilitation sessions according to the individually generated strength.
| Study group | Role | What they receive |
|---|---|---|
| LUNA-EMG | Experimental | The experimental group will receive 30 minutes of training with the LUNA-EMG for 12 weeks. Receives: Device: LUNA-EMG |
| Control | No intervention | The control group will receive its rehabilitation care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscular strength in mV
muscular strength will be measured with the EMG
Measured: 12 weeks
Secondary outcomes (3)
Fugl-Meyer
The scale evaluates motor capacities of the upper limb following a stroke. Scores range from 0 to 66 (the higher the better).
Measured: 12 weeks
Modified Ashworth Scale
This scale measures spasticity. The results are scored from 0 to 4 (the higher the more spastic).
Measured: 12 weeks
Lovett
This scale measures muscular strength. The scale ranges from 0 to 5 (the higher the better).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start1 Mar 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 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
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Liege
- Responsible party
- Principal investigator, Aurore Thibaut, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716829
- Sponsor's protocol ID
- 2020-372
- Acronym
- LUNA
- Status last verified
- Jul 2025
- First submitted
- 19 Jan 2021
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy of the LUNA-EMG System on Motor Function in the Management of Neurological Disorders.
- ClinicalTrials.gov ID
- NCT04716829
- Acronym / sponsor ID
- LUNA / 2020-372
- Conditions
- Stroke
- Keywords
- stroke, EMG, rehabilitation, physiotherapy, occupational therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Liege
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 20 Jan 2021 (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 aim of the present study is to evaluate the effects of training performed with the LUNA-EMG system to enhance motor functions of the upper limb in stroke This is a randomized open-label trial. Patients will be randomized into the intervention group (LUNA-EMG) or in the control group (standard care).
The effect of the training will be measured with the EMG, the upper limb motor function and the quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LUNA-EMG | Experimental | Device: LUNA-EMGThe experimental group will receive 30 minutes of training with the LUNA-EMG for 12 weeks. |
| Control | No intervention | –The control group will receive its rehabilitation care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult
- Having signed the informed consent
Key exclusion criteria (8 listed)
- Acute pain syndrome
- Severe cognitive deficits
- Risk of fracture or unconsolidated fracture
- Rigid joints (spasticity, severe osteoarthritis and arthritis) or unstable joints
- Severe ataxia and apraxia
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-EMGThe LUNA-EMG (Samcom) system is a robot that allows the evaluation of muscular strength through the recording of muscle activity (electromyography - EMG) in order to provide precise objective data on the patient's muscle function. In addition to the diagnostic aspect (evaluation of muscle strength, range of motion and proprioception), the LUNA-EMG robot allows the adaptation of movements during rehabilitation sessions according to the individually generated strength. | Device | LUNA-EMG |
Primary outcome
muscular strength in mV
Time frame: 12 weeks
muscular strength will be measured with the EMG
3 secondary outcomes
Fugl-Meyer
Time frame: 12 weeks
Modified Ashworth Scale
Time frame: 12 weeks
Lovett
Time frame: 12 weeks
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 5 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Stroke, run by University of Liege at 1 site in Belgium.
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 2 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 5 Aug 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 Belgium. 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?
muscular strength in mV (time frame: 12 weeks). 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 5 Aug 2025.