Subacute StrokeREM_AVCNCT01383512
Rehabilitation Robotics After a Stroke
A study testing ARMEO Spring and Self rehabilitation in people with Subacute Stroke, run by University Hospital, Brest at 23 sites in France.
Trial summary
Upper limb motor control after a stroke may be improved with rehabilitation robotics at a subacute stage. The aim of this multicenter controled randomized single blind study is to define the place of rehabilitation robotics at this phase of the rehabilitation process. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Subacute Stroke
- What is being tested?
- ARMEO Spring and Self rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 23 sitesFrance
- Study dates
- Jun 2011to 5 Dec 2017
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ischemic or hemorrhagic stroke of the middle cerebral arteria territory
- 18 to 80 years old
- stroke onset between 3 weeks to 3 months,with or without aphasia, with or without lateral neglect and homonymous hemianopia, with or without visual neglect
- 10<or= Fugl Meyer upper limb Score <or= 40
- upper limbs pain less or equal than 3/10 (VAS)
- inpatient or outpatient rehabilitation
- signed inform consent
Who cannot join
- ischemic or hemorrhagic stroke of anterior or posterior cerebral artery
- ischemic or hemorrhagic stroke of the brainstem
- major aphasia evaluated by a Boston Diagnostic Aphasia Examination (BDAE) score less or equal to 3
- asthenia not allowing to work 60 minutes with the robot.
- serious visual deficiency not allowing to use the robot
- impossibility to install the arm on the robot because of a serious and uncontrolled spasticity or for any other reason
Show all 16Show fewer
- pronounced and constant muscular contractures, or deformation affecting the use of the extremity
- upper limb's pain superior to 3/10 and/or being worse at the active and passive mobilization
- serious infection and/or instability of vital functions
- perfusion of the affected upper limb not removable
- incapacity to stay on a chair
- contraindicated sitting position
- permanent deviation of the head and\or of the eyes
- perturbed or non-cooperative patient
- patients that must have to be isolated due to an infection process
- bone fracture of the paretic limb with an onset less than 3 months stabilized or not
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
France23 sites
CHU d'Amiens
Amiens, 80000
CRRRF
Angers, 49000
CHU de Bordeaux
Bordeaux, 33073
CHRU de Brest
Brest, 29609
Centre Bouffard Vercelli
Cervera de la Marenda, 66290
CHU de Clermont-Ferrand
Clermont-Ferrand, 63118
CHU de Dijon
Dijon, 21079
CH de Garches
Garches, 92380
EMPR Le Normandy
Granville, 54000
CHU de Nîmes
Le Grau-du-Roi, 30029
CHRU de Lille
Lille, 59037
CHU de Limoges
Limoges, 87042
CHU de Lyon
Lyon, 69000
CRF de Valmante
Marseille, 13275
CHU de Montpellier
Montpellier, 34172
IRR de Nancy
Nancy, 54690
CHU de Nantes
Nantes, 44093
APHP - Hôpital La Salpétriere
Paris, 75000
APHP - Hôpital Lariboisière
Paris, 75000
CMRRF Kerpape
Ploemeur, 56275
CHU de Reims
Reims, 51100
CHU de Rennes
Rennes, 35 033
CHU de Toulouse
Toulouse, 31059
About this study
Official title: Medical and Economical Evaluation of Upper Limb's Rehabilitation Robotics After a Stroke
Upper limb motor control after a stroke may be improved with rehabilitation robotics at a subacute stage. The aim of this multicenter controled randomized single blind study is to define the place of rehabilitation robotics at this phase of the rehabilitation process. Both groups will realize the same time of rehabilitation. The cost benefit ratio will be compared in each group through medical assessment of improvement and definition of the costs due to the rehabilitation process.
- Conditions
- Subacute Stroke
- Being tested
- ARMEO Spring, Self rehabilitation
- Keywords
- stroke, rehabilitation, robotics, motor control, upper limb
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARMEO SpringDevice
Use of the device 1 hour per day, 5 days per week during 4 weeks
Self rehabilitationOther
Subject have to realised alone rehabilitation exercises 1 hour per day, 5 days per week during 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation robotics | Experimental | Subjects will be practicing an Armeo Spring rehabilitation program in addition to their usual care (1.5h/day,5d/week) 1h/day 5d/week 4 weeks. Receives: Device: ARMEO Spring |
| Self-rehabilitation | Active comparator | Subject will associated to there classical care 1 hours, 5 days per week during 4 weeks, of self rehabilitation. Receives: Other: Self rehabilitation |
| Healthy volunteer | Other | 20 healthy volunteer will be recruiting and using ARMEO Spring. All volunteer will repeat 5 times the same program on the medical device. Receives: Device: ARMEO Spring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer upper limb motor score
Increase of the Fugl Meyer score between day 0 and day 30 with a difference between groups by at least 4 points
Measured: Day 30
Secondary outcomes (4)
Costs
The rehabilitation costs will be assessed for each group through medical and physiotherapist consultations, hospitalization costs, day of return to work if concerned.
Measured: One year
Stroke impact scale (SIS)
The quality of life will be assessed through the SIS.
Measured: One year
Visual analog scale (VAS)
The pain of the shoulder and the upper limb will be assessed in different positions
Measured: Day 7,14,21,30, 90,180, 360
Modification of motor control
Parameter and result of rehabilitation program on ARMEO spring are saved. Data of patient in rehabilitation robotics and healthy volunteer arms will be compared in order to evaluate the modification of the motor control at Day 30.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startJun 2011
- Primary completion5 Dec 2017
- Study completion5 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Subacute 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Olivier REMY-NERIS, Professor, Principal investigator, University Hospital, Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383512
- Sponsor's protocol ID
- REM_AVC
- Acronym
- REM_AVC
- Status last verified
- Jan 2025
- First submitted
- 27 Jun 2011
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cornec G, Lempereur M, Mensah-Gourmel J, Robertson J, Miramand L, Medee B, Bellaiche S, Gross R, Gracies JM, Remy-Neris O, Bayle N. Measurement properties of movement smoothness metrics for upper limb reaching movements in people with moderate to severe subacute stroke. J Neuroeng Rehabil. 2024 May 29;21(1):90. doi: 10.1186/s12984-024-01382-1.
PubMed 38812037Remy-Neris O, Le Jeannic A, Dion A, Medee B, Nowak E, Poiroux E, Durand-Zaleski I; REM Investigative Team*. Additional, Mechanized Upper Limb Self-Rehabilitation in Patients With Subacute Stroke: The REM-AVC Randomized Trial. Stroke. 2021 Jun;52(6):1938-1947. doi: 10.1161/STROKEAHA.120.032545. Epub 2021 Apr 29.
PubMed 33910364
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical and Economical Evaluation of Upper Limb's Rehabilitation Robotics After a Stroke
- ClinicalTrials.gov ID
- NCT01383512
- Acronym / sponsor ID
- REM_AVC / REM_AVC
- Conditions
- Subacute Stroke
- Keywords
- stroke, rehabilitation, robotics, motor control, upper limb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jun 2011 (actual)
- Primary completion
- 5 Dec 2017 (actual)
- Study completion
- 5 Dec 2017 (actual)
- First posted
- 28 Jun 2011 (estimated)
- 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.
Upper limb motor control after a stroke may be improved with rehabilitation robotics at a subacute stage. The aim of this multicenter controled randomized single blind study is to define the place of rehabilitation robotics at this phase of the rehabilitation process. Both groups will realize the same time of rehabilitation. The cost benefit ratio will be compared in each group through medical assessment of improvement and definition of the costs due to the rehabilitation process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation robotics | Experimental | Device: ARMEO SpringSubjects will be practicing an Armeo Spring rehabilitation program in addition to their usual care (1.5h/day,5d/week) 1h/day 5d/week 4 weeks. |
| Self-rehabilitation | Active comparator | Other: Self rehabilitationSubject will associated to there classical care 1 hours, 5 days per week during 4 weeks, of self rehabilitation. |
| Healthy volunteer | Other | Device: ARMEO Spring20 healthy volunteer will be recruiting and using ARMEO Spring. All volunteer will repeat 5 times the same program on the medical device. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ischemic or hemorrhagic stroke of the middle cerebral arteria territory
- 18 to 80 years old
- stroke onset between 3 weeks to 3 months,with or without aphasia, with or without lateral neglect and homonymous hemianopia, with or without visual neglect
- 10<or= Fugl Meyer upper limb Score <or= 40
- upper limbs pain less or equal than 3/10 (VAS)
Key exclusion criteria (16 listed)
- ischemic or hemorrhagic stroke of anterior or posterior cerebral artery
- ischemic or hemorrhagic stroke of the brainstem
- major aphasia evaluated by a Boston Diagnostic Aphasia Examination (BDAE) score less or equal to 3
- asthenia not allowing to work 60 minutes with the robot.
- serious visual deficiency not allowing to use the robot
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 |
|---|---|---|
| ARMEO SpringUse of the device 1 hour per day, 5 days per week during 4 weeks | Device | Healthy volunteer, Rehabilitation robotics |
| Self rehabilitationSubject have to realised alone rehabilitation exercises 1 hour per day, 5 days per week during 4 weeks. | Other | Self-rehabilitation |
Primary outcome
Fugl Meyer upper limb motor score
Time frame: Day 30
Increase of the Fugl Meyer score between day 0 and day 30 with a difference between groups by at least 4 points
4 secondary outcomes
Costs
Time frame: One year
Stroke impact scale (SIS)
Time frame: One year
Visual analog scale (VAS)
Time frame: Day 7,14,21,30, 90,180, 360
Modification of motor control
Time frame: Day 30
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 Jan 2025.
- Derived from this study: PubMed 38812037Cornec G, Lempereur M, Mensah-Gourmel J, Robertson J, Miramand L, Medee B, Bellaiche S, Gross R, Gracies JM, Remy-Neris O, Bayle N. Measurement properties of movement smoothness metrics for upper limb reaching movements in people with moderate to severe subacute stroke. J Neuroeng Rehabil. 2024 May 29;21(1):90. doi: 10.1186/s12984-024-01382-1.
- Derived from this study: PubMed 33910364Remy-Neris O, Le Jeannic A, Dion A, Medee B, Nowak E, Poiroux E, Durand-Zaleski I; REM Investigative Team*. Additional, Mechanized Upper Limb Self-Rehabilitation in Patients With Subacute Stroke: The REM-AVC Randomized Trial. Stroke. 2021 Jun;52(6):1938-1947. doi: 10.1161/STROKEAHA.120.032545. Epub 2021 Apr 29.
Related trials for Subacute Stroke
Active, not recruiting
Comparative Effects of Sensorimotor Training and tACS on Upper Limb Function and Cervical Proprioception in Subacute Stroke
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Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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MSC Secretome and rTMS for Motor Recovery After Subacute Ischemic Stroke
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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. This study is not recruiting at the moment.
Olivier REMY-NERIS, Professor principal investigator
University Hospital, Brest
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARMEO Spring and Self rehabilitation in people with Subacute Stroke, run by University Hospital, Brest at 23 sites 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 7 inclusion and 16 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 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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?
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?
Fugl Meyer upper limb motor score (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01383512, which also lists 2 linked publications.
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 Jan 2025.