StrokeLUNASTROKENCT05902910
Efficacy and Acceptability of the Luna EMG Rehabilitation Robot on Motor Recovery of the Upper Limb in the Chronic Phase of Stroke
A study testing LUNA-EMG Robot in people with Stroke, run by University Hospital, Brest at 1 site in France.
Trial summary
Recent work on large cohorts of chronic stroke (>6 months post-stroke) have shown that intensive training of the upper limb in the chronic stroke patients can lead to substantial motor and functional gains that are maintained at 6 months post intervention. 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 Robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2023to 12 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age >= 18 years
- Hemiparesis after a first stroke with more than 1 year time interval
- Functional upper limb: ability to do a pointing task at 90% of the hand-acromion distance (free trunk).
- Spastic hypertonia of the elbow flexors 0-2/4 on the Modified Ashworth scale
- Patient affiliated with social security
- Patient having signed a consent to participate in the research
Who cannot join
- Inability to sign written consent
- Flexed elbow > 30° during passive mobilization of the upper limb
- EVA>3 in the upper limb at rest or during mobilization
- Complete loss of upper limb proprioception
- Neuro-orthopedic surgery of the upper limb for spasticity: neurotomy, tenotomy, transfer
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gwenaël Cornec, MD contact
France1 site, 1 recruiting
- Recruiting
CHU Brest
Brest, 29200
Olivier Remy-Neris, PU-PH, +332 98 22 31 52, olivier.remyneris@chu-brest.fr
Olivier Remy-Neris, PU-PH
About this study
Official title: Efficacy and Acceptability of the Luna EMG Rehabilitation Robot on Motor Recovery of the Upper Limb in the Chronic Phase of Stroke, Experimental Study in Single Cases.
Recent work on large cohorts of chronic stroke (>6 months post-stroke) have shown that intensive training of the upper limb in the chronic stroke patients can lead to substantial motor and functional gains that are maintained at 6 months post intervention.
A very prolonged (12 weeks) and very intensive (5 hours daily) training applied to chronic patients after stroke brings a substantial gain both motor and functional which is maintained at 3 months post intervention.
Read more
Robotic rehabilitation have been shown to be as effective as any other treatment used in rehabilitation. But the methods of implementation remain widely debated. At that time, most robotic therapies have tried to reproduce functional movement mainly pointing objects.
We want to demonstrate that analytic movements of the elbow and the shoulder performed with the Luna-EMG robot can replace part of usual physiotherapy treatment with at least the same effectiveness on the recovery of fluid movements of the upper limb after a stroke.
Read the detailed description
This is a pilot study following a single case experimental design with multiple baselines across subjects (MBD).
People included in the protocol will benefit from 2 hours of daily treatment during 6 to 7.5 weeks. The first 2 weeks will be dedicated to baseline measurement of their upper limb (UL) status with daily treatment for balance and gait control without any treatment of the upper limb. The rest of the time will be dedicated to upper limb treatment exclusively. It will be divided into 2 UL training periods, one of them including a 30mn treatment with the luna EMG robot. The duration of second period will be randomly defined between 2 to 3.5 weeks and the last period will last 2 weeks. The treatment during the first UL treatment period will be randomly allocated to Luna EMG treatment or not. The next period will thus follow the inverse scheme (without if the first contains Luna EMG treatment). The fluidity will be assessed through pointing movements assessed every two days. Evaluation of motor deficiency (Fugl Meyer) and functional status (ARAT score) of the UL will be weekly assessed after the inclusion visit. 3D motion analysis of the UL will also be weekly performed.
All patients will benefit from a regular follow-up and from an organized care protocol. The sessions will be intensive, all subjects will be able to benefit from the new treatment (LUNA EMG). We can expect a direct individual benefit from the proposed intensive treatment, at least for precision of UL movements.
- Conditions
- Stroke
- Being tested
- LUNA-EMG Robot
- Keywords
- Robot, Joint
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUNA-EMG RobotDevice
During phase B, patients will benefit from functional rehabilitation of their upper limbs and from 30mn of training assisted by the LUMA-EMG robot.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Scheme : A,B,C | Active comparator | The phase B treatment (1.5 hours a day, 5/7 days of conventional rehabilitation and 30mn a day, 5/7 days of treatment with the robot) is scheduled before phase C (2 hours a day, 5/7 days of conventional rehabilitation). The duration of phase B is randomized between 6 and 11 evaluations (2 to 3.5 weeks). Receives: Device: LUNA-EMG Robot |
| Experimental Scheme : A,C,B | Active comparator | The phase C treatment (2 hours a day, 5/7 days of conventional rehabilitation) is scheduled before phase B (1.5 hours a day, 5/7 days of conventional rehabilitation and 30mn a day, 5/7 days of treatment with the robot). The duration of phase C is randomized between 6 and 11 evaluations (2 to 3.5 weeks). Receives: Device: LUNA-EMG Robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluidity of the upper limb
Repeated evaluation of hand movement by the SPARC index during five pointing tasks at 90% of the length of the upper limb at clavicle height, at comfortable speed.
Measured: up to 7.5weeks
Secondary outcomes (9)
Pain assessment
Use of Visual Analog Scale (VAS) to evaluate the painful (between 0: no pain to 10: intolerable pain)
Measured: up to 7.5weeks
Motricity assessment
Use of the Fugl-Meyer index (between 0: no motricity to 66: total member motricity)
Measured: up to 7.5weeks
Function assessment
ARAT (Action Research Arm Test) measurement to assess specific changes in limb function (from 0 to 57, a low score indicating that the movements cannot be performed, and a high score indicating normal performance)
Measured: up to 7.5weeks
Duration of movement
Kinematic parameter measured 3 times per week
Measured: up to 7.5weeks
Straightness of movement
Kinematic parameter measured 3 times per week : the trajectory of the hand during pointing movement at a distance normalised by the length of the upper limb will be assessed in motion capture (12 VICONR cameras). The smoothness of the trajectory will be measured by the SPARC (spectral arc length measure) during forward and backward movement.
Measured: up to 7.5weeks
Average speed of movement
Kinematic parameter measured 3 times per week : the trajectory of the hand during pointing movement at a distance normalised by the length of the upper limb will be assessed in motion capture (12 VICONR cameras). The spatiotemporal parameters (time, distance, average speed) will be measured between the starting position (in front of the trunc) and the final pointed object during forward and backward movement.
Measured: up to 7.5weeks
Acceptability of the use of the robot
Score between 0 to 100 (a low score indicate that the robot is not well accepted, and a high score indicate a well acceptability)
Measured: up to 7.5weeks
Satisfaction of the use of the robot
Score between 0 to 100 (0: not satisfied, 100: very satisfied)
Measured: up to 7.5weeks
Spasticity
Ashworth scale measured 3 times a week and Nottingham scale measured 1 time at inclusion)
Measured: up to 7.5weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start12 Jun 2023
- Primary completion12 Jun 2026 (estimated)
- Study completion12 Jun 2026 (estimated)
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.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The multiple-baseline SCED design is a prospective design that allows the intensive study of a few individuals to measure their baseline and condition related to a therapeutic intervention. Each subject is his own control with repeated measurements of the primary endpoint. Randomization in the MBD formats of SCED studies relates to the duration of the phases. The experimental plan includes 3 rehabilitation phases: A (Baseline), B (1.5hours a day 5/7 of conventional rehabilitation and 30mn of training with the Luna robot 5/7) and C (2 hours a day 5/7 of conventional rehabilitation). The duration of phase A is fixed (2 weeks). As the effect of the treatment on the upper limb is unknown in its latency, the duration of the second phase of the study will be randomized (2 to 3.5 weeks). Finally, the duration of the third phase is fixed (2 weeks)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- EGZOTech
- Responsible party
- Sponsor
- Investigators
- Olivier Remy-Neris, PU-PH, Principal investigator, CHRU BREST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902910
- Sponsor's protocol ID
- 29BRC21.0393
- Other IDs
- 2022-A00096-37
- Acronym
- LUNASTROKE
- Status last verified
- Jun 2026
- First submitted
- 9 Mar 2022
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Acceptability of the Luna EMG Rehabilitation Robot on Motor Recovery of the Upper Limb in the Chronic Phase of Stroke, Experimental Study in Single Cases.
- ClinicalTrials.gov ID
- NCT05902910
- Acronym / sponsor ID
- LUNASTROKE / 29BRC21.0393
- Conditions
- Stroke
- Keywords
- Robot, Joint
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- EGZOTech
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 12 Jun 2026 (estimated)
- Study completion
- 12 Jun 2026 (estimated)
- First posted
- 15 Jun 2023 (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.
Recent work on large cohorts of chronic stroke (>6 months post-stroke) have shown that intensive training of the upper limb in the chronic stroke patients can lead to substantial motor and functional gains that are maintained at 6 months post intervention.
A very prolonged (12 weeks) and very intensive (5 hours daily) training applied to chronic patients after stroke brings a substantial gain both motor and functional which is maintained at 3 months post intervention.
Robotic rehabilitation have been shown to be as effective as any other treatment used in rehabilitation. But the methods of implementation remain widely debated. At that time, most robotic therapies have tried to reproduce functional movement mainly pointing objects.
We want to demonstrate that analytic movements of the elbow and the shoulder performed with the Luna-EMG robot can replace part of usual physiotherapy treatment with at least the same effectiveness on the recovery of fluid movements of the upper limb after a stroke.
Detailed description
This is a pilot study following a single case experimental design with multiple baselines across subjects (MBD).
People included in the protocol will benefit from 2 hours of daily treatment during 6 to 7.5 weeks. The first 2 weeks will be dedicated to baseline measurement of their upper limb (UL) status with daily treatment for balance and gait control without any treatment of the upper limb. The rest of the time will be dedicated to upper limb treatment exclusively. It will be divided into 2 UL training periods, one of them including a 30mn treatment with the luna EMG robot. The duration of second period will be randomly defined between 2 to 3.5 weeks and the last period will last 2 weeks. The treatment during the first UL treatment period will be randomly allocated to Luna EMG treatment or not. The next period will thus follow the inverse scheme (without if the first contains Luna EMG treatment). The fluidity will be assessed through pointing movements assessed every two days. Evaluation of motor deficiency (Fugl Meyer) and functional status (ARAT score) of the UL will be weekly assessed after the inclusion visit. 3D motion analysis of the UL will also be weekly performed.
All patients will benefit from a regular follow-up and from an organized care protocol. The sessions will be intensive, all subjects will be able to benefit from the new treatment (LUNA EMG). We can expect a direct individual benefit from the proposed intensive treatment, at least for precision of UL movements.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The multiple-baseline SCED design is a prospective design that allows the intensive study of a few individuals to measure their baseline and condition related to a therapeutic intervention. Each subject is his own control with repeated measurements of the primary endpoint. Randomization in the MBD formats of SCED studies relates to the duration of the phases. The experimental plan includes 3 rehabilitation phases: A (Baseline), B (1.5hours a day 5/7 of conventional rehabilitation and 30mn of training with the Luna robot 5/7) and C (2 hours a day 5/7 of conventional rehabilitation). The duration of phase A is fixed (2 weeks). As the effect of the treatment on the upper limb is unknown in its latency, the duration of the second phase of the study will be randomized (2 to 3.5 weeks). Finally, the duration of the third phase is fixed (2 weeks)
| Arm | Type | Receives |
|---|---|---|
| Experimental Scheme : A,B,C | Active comparator | Device: LUNA-EMG RobotThe phase B treatment (1.5 hours a day, 5/7 days of conventional rehabilitation and 30mn a day, 5/7 days of treatment with the robot) is scheduled before phase C (2 hours a day, 5/7 days of conventional rehabilitation). The duration of phase B is randomized between 6 and 11 evaluations (2 to 3.5 weeks). |
| Experimental Scheme : A,C,B | Active comparator | Device: LUNA-EMG RobotThe phase C treatment (2 hours a day, 5/7 days of conventional rehabilitation) is scheduled before phase B (1.5 hours a day, 5/7 days of conventional rehabilitation and 30mn a day, 5/7 days of treatment with the robot). The duration of phase C is randomized between 6 and 11 evaluations (2 to 3.5 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >= 18 years
- Hemiparesis after a first stroke with more than 1 year time interval
- Functional upper limb: ability to do a pointing task at 90% of the hand-acromion distance (free trunk).
- Spastic hypertonia of the elbow flexors 0-2/4 on the Modified Ashworth scale
- Patient affiliated with social security
Key exclusion criteria (6 listed)
- Inability to sign written consent
- Flexed elbow > 30° during passive mobilization of the upper limb
- EVA>3 in the upper limb at rest or during mobilization
- Complete loss of upper limb proprioception
- Neuro-orthopedic surgery of the upper limb for spasticity: neurotomy, tenotomy, transfer
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-EMG RobotDuring phase B, patients will benefit from functional rehabilitation of their upper limbs and from 30mn of training assisted by the LUMA-EMG robot. | Device | Experimental Scheme : A,B,C, Experimental Scheme : A,C,B |
Primary outcome
Fluidity of the upper limb
Time frame: up to 7.5weeks
Repeated evaluation of hand movement by the SPARC index during five pointing tasks at 90% of the length of the upper limb at clavicle height, at comfortable speed.
9 secondary outcomes
Pain assessment
Time frame: up to 7.5weeks
Motricity assessment
Time frame: up to 7.5weeks
Function assessment
Time frame: up to 7.5weeks
Duration of movement
Time frame: up to 7.5weeks
Straightness of movement
Time frame: up to 7.5weeks
Average speed of movement
Time frame: up to 7.5weeks
Acceptability of the use of the robot
Time frame: up to 7.5weeks
Satisfaction of the use of the robot
Time frame: up to 7.5weeks
Spasticity
Time frame: up to 7.5weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for 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
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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.
Gwenaël Cornec, MD contact
Olivier Remy-Neris, PU-PH principal investigator
CHRU BREST
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 Robot in people with Stroke, run by University Hospital, Brest at 1 site in France.
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 6 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: looking for participants now, as of the sponsor's last update on 10 Jun 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier Remy-Neris, PU-PH (+33 2 98 22 31 52, olivier.remyneris@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluidity of the upper limb (time frame: up to 7.5weeks). 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 10 Jun 2026.