HealthyARTHEMIRSNCT04738851
Study of Cerebral Activation During Different Rehabilitation Tasks in Mirror Therapy in Healthy Subjects
A study testing Therapy Mirror task in people with Healthy, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
The purpose of this study is to investigate the cerebral activation during Classic Mirror Therapy (TMC) and especially during Virtual Mirror Therapy (TMV) in healthy subjects. It seems that the precuneus is involved in the effectiveness of mirror therapy. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Therapy Mirror task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2021to 4 Mar 2021
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age:18 to 40
- Right handed
- No neurological disease
Who cannot join
- Known allergy to components of the fNIRS device: neoprene
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ARTHEMIRS: Assessment of Brain Activation During Different Mirror Therapy Tasks Using fNIRS Technology
The purpose of this study is to investigate the cerebral activation during Classic Mirror Therapy (TMC) and especially during Virtual Mirror Therapy (TMV) in healthy subjects. It seems that the precuneus is involved in the effectiveness of mirror therapy. One goal of this study is to determine if there is a better activation of the precuneus during TMV than during TMC. Others goals are to compare cerebral activation during three different tasks (TMV, TMC and a simple motor task), to study the intra-subjects reproducibility of the measurement and the correlation between cerebral activation and feelings of the participants about the efficacity of the tasks.
Read the detailed description
Mirror therapy is a rehabilitation technique that has been shown to be effective in restoring upper limb motor skills in patients with stroke. However, it comes up against certain constraints of clinical use such as installation difficulties or the obligation of symmetrical bilateral work. These constraints can be limited by the use of so-called 2nd generation virtual mirror therapy technologies. It is therefore likely that these new technologies will improve the feasibility and effectiveness of mirror therapy in rehabilitation. While the brain mechanisms involved in mirror therapy are not yet fully understood, the involvement of the precuneus has been demonstrated by a booming imaging method: fNIRS (functional Near Infra Red Spectroscopy). This method allows (like fMRI) to study cerebral neurovascular coupling. It is based on the fact that an activated region of the brain increases its local blood flow. Oxygenated hemoglobin (HbO) and deoxygenated (HbR) absorb infrared light and it is then possible to identify the cortical regions of the brain involved in a given task. This technique therefore makes it possible to study brain activation under more ecological conditions than fMRI and is therefore particularly suitable for exploring rehabilitation techniques.
This research aims to study and compare in healthy subjects, using a fNIRS apparatus, the brain regions involved in the performance of a classic mirror therapy task and a virtual mirror therapy task with the IVS3 (Intensive Visual Simulation) apparatus (Dessintey Technology).
The investigations will be carried out by the principal investigator or by specialized technicians from the neurology functional exploration department.
Each acquisition has a duration of 620 seconds, it begins with a rest period of 120 seconds, which corresponds to the baseline.
For each condition the movements are performed at a frequency of 0.5 Hz which seems to be the optimal frequency for observing cortical activation using a metronome. Each movement is therefore performed 10 times per block.
The order of placing the various conditions will be balanced. Between periods of movement, the subject is in a resting position for 30 seconds.
The "movement" and "rest" instructions are given at the start of each phase. The entire test will be repeated one week apart to assess the reproducibility of the measurements in healthy subjects.
The protocol has 3 conditions:
- A virtual TM task (TMV)
- A classic TM task (TMC)
- A control task (TC) Healthy subjects participating in the study will have two different acquisition times, each comprising 3 conditions.
After recruiting the subjects, the study investigator will check the inclusion and non-inclusion criteria.
If the subject can integrate the protocol, the two acquisition stages will then be scheduled one week apart.
On the day of the first acquisition, the subject will present to the neurology department at the time of his appointment.
The order of the 3 conditions will then be randomized to avoid potential biases linked to the sequence of conditions.
Then the fNIRS acquisition headset (Brite 24) will be installed by a specialized technician and the procurement instructions will be given.
The acquisition under the 3 conditions is then carried out: TC1, TMC1, TMV1 with a rest time of 10 minutes between each condition.
The subject's feelings after the TMC and TMV conditions will be evaluated using the visual analogue scale (VAS). 0 corresponding to a zero feeling and 10 to a very important feeling. The subject will be explained that the feeling could correspond to tingling sensations, a desire to mobilize the hand which is behind the mirror, a "disturbing", "bizarre" sensation.
The helmet is only removed at the end of the 3 spots The subject returns a week later for the 2nd acquisition phase during which the same acquisitions as during the 1st meeting are carried out and then participation in the study is terminated.
There will therefore be 6 tests for each healthy subject.
- Conditions
- Healthy
- Being tested
- Therapy Mirror task
- Keywords
- mirror therapy, near infrared spectroscopy, cerebral activation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapy Mirror taskOther
The protocol has 3 conditions:
- A virtual TM task (TMV
- A classic TM task (TMC)
- A control task (TC)
The order of the 3 conditions will then be randomized to avoid potential biases linked to the sequence of conditions.
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Experimental | Virtual mirror therapy task : TMV Classic mirror therapy task : TMC Control task :TC Receives: Other: Therapy Mirror task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the level of precuneus activation during conventional mirror therapy (TMC) and virtual mirror therapy (TMV)
Changes in the concentration of oxyhemoglobin and deoxyhemoglobin measured with fnirs device
Measured: Day 0
Secondary outcomes (8)
Compare the level of activation of the precuneus during TMC and TC.
Changes in the concentration of oxyhemoglobin and deoxyhemoglobin measured with fnirs device
Measured: Day 0
Compare the level of precuneus activation during TMV and TC.
Changes in the concentration of oxyhemoglobin and deoxyhemoglobin measured with fnirs (functional Near Infra Red Spectroscopy) device
Measured: Day 0
Compare the level of activation of contralateral motor regions to visual feedback during TMC and TMV.
Changes in the concentration of oxyhemoglobin and deoxyhemoglobin measured with fnirs (functional Near Infra Red Spectroscopy) device
Measured: Day 0
Compare the level of activation of the contralateral motor regions to visual feedback during TMV and TC.
Changes in the concentration of oxyhemoglobin and deoxyhemoglobin measured with fnirs (functional Near Infra Red Spectroscopy) device
Measured: Day 0
Compare the level of activation of the contralateral motor regions to visual feedback during TMC and TC.
Changes in the concentration of oxyhemoglobin and deoxyhemoglobin measured with fnirs (functional Near Infra Red Spectroscopy) device
Measured: Day 0
Evaluate the reproducibility of measurements
Changes in the concentration of oxyhemoglobin and deoxyhemoglobin measured with fnirs (functional Near Infra Red Spectroscopy) device
Measured: Day 0
Evaluate the reproducibility of measurements
Changes in the concentration of oxyhemoglobin and deoxyhemoglobin measured with fnirs (functional Near Infra Red Spectroscopy) device
Measured: Day 7
Compare the cortical regions involved during the different mirror therapy tasks and the feelings of the subjects.
Visual Analog Scale (VAS), minimal score is 0 (worst score) maximal score is 10 (better score)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start8 Feb 2021
- Primary completion4 Mar 2021
- Study completion4 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien BONNAL, Principal investigator, CHR d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738851
- Sponsor's protocol ID
- CHRO 2020-14
- Acronym
- ARTHEMIRS
- Status last verified
- May 2021
- First submitted
- 1 Feb 2021
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Altschuler EL, Wisdom SB, Stone L, Foster C, Galasko D, Llewellyn DM, Ramachandran VS. Rehabilitation of hemiparesis after stroke with a mirror. Lancet. 1999 Jun 12;353(9169):2035-6. doi: 10.1016/s0140-6736(99)00920-4. No abstract available.
PubMed 10376620Bae SJ, Jang SH, Seo JP, Chang PH. The Optimal Speed for Cortical Activation of Passive Wrist Movements Performed by a Rehabilitation Robot: A Functional NIRS Study. Front Hum Neurosci. 2017 Apr 20;11:194. doi: 10.3389/fnhum.2017.00194. eCollection 2017.
PubMed 28473763Bai Z, Fong KNK, Zhang J, Hu Z. Cortical mapping of mirror visual feedback training for unilateral upper extremity: A functional near-infrared spectroscopy study. Brain Behav. 2020 Jan;10(1):e01489. doi: 10.1002/brb3.1489. Epub 2019 Dec 5.
PubMed 31805613Brunetti M, Morkisch N, Fritzsch C, Mehnert J, Steinbrink J, Niedeggen M, Dohle C. Potential determinants of efficacy of mirror therapy in stroke patients--A pilot study. Restor Neurol Neurosci. 2015;33(4):421-34. doi: 10.3233/RNN-140421.
PubMed 26409402Calautti C, Jones PS, Naccarato M, Sharma N, Day DJ, Bullmore ET, Warburton EA, Baron JC. The relationship between motor deficit and primary motor cortex hemispheric activation balance after stroke: longitudinal fMRI study. J Neurol Neurosurg Psychiatry. 2010 Jul;81(7):788-92. doi: 10.1136/jnnp.2009.190512. Epub 2010 Apr 14.
PubMed 20392975Chang CS, Lo YY, Chen CL, Lee HM, Chiang WC, Li PC. Alternative Motor Task-Based Pattern Training With a Digital Mirror Therapy System Enhances Sensorimotor Signal Rhythms Post-stroke. Front Neurol. 2019 Nov 22;10:1227. doi: 10.3389/fneur.2019.01227. eCollection 2019.
PubMed 31824406Darbois N, Guillaud A, Pinsault N. Do Robotics and Virtual Reality Add Real Progress to Mirror Therapy Rehabilitation? A Scoping Review. Rehabil Res Pract. 2018 Aug 19;2018:6412318. doi: 10.1155/2018/6412318. eCollection 2018.
PubMed 30210873Ferrari M, Quaresima V. A brief review on the history of human functional near-infrared spectroscopy (fNIRS) development and fields of application. Neuroimage. 2012 Nov 1;63(2):921-35. doi: 10.1016/j.neuroimage.2012.03.049. Epub 2012 Mar 28.
PubMed 22510258Giraux P, Sirigu A. Illusory movements of the paralyzed limb restore motor cortex activity. Neuroimage. 2003 Nov;20 Suppl 1:S107-11. doi: 10.1016/j.neuroimage.2003.09.024.
PubMed 14597303Harmsen WJ, Bussmann JB, Selles RW, Hurkmans HL, Ribbers GM. A Mirror Therapy-Based Action Observation Protocol to Improve Motor Learning After Stroke. Neurorehabil Neural Repair. 2015 Jul;29(6):509-16. doi: 10.1177/1545968314558598. Epub 2014 Nov 21.
PubMed 25416737Inagaki Y, Seki K, Makino H, Matsuo Y, Miyamoto T, Ikoma K. Exploring Hemodynamic Responses Using Mirror Visual Feedback With Electromyogram-Triggered Stimulation and Functional Near-Infrared Spectroscopy. Front Hum Neurosci. 2019 Feb 26;13:60. doi: 10.3389/fnhum.2019.00060. eCollection 2019.
PubMed 30863295Jihun Kim, Jaehyo Kim. Robot-assisted mirroring exercise as a physical therapy for hemiparesis rehabilitation. Annu Int Conf IEEE Eng Med Biol Soc. 2017 Jul;2017:4243-4246. doi: 10.1109/EMBC.2017.8037793.
PubMed 29060834Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke. 2003 Sep;34(9):2181-6. doi: 10.1161/01.STR.0000087172.16305.CD. Epub 2003 Aug 7.
PubMed 12907818Lee HM, Li PC, Fan SC. Delayed mirror visual feedback presented using a novel mirror therapy system enhances cortical activation in healthy adults. J Neuroeng Rehabil. 2015 Jul 11;12:56. doi: 10.1186/s12984-015-0053-1.
PubMed 26160599Li YC, Wu CY, Hsieh YW, Lin KC, Yao G, Chen CL, Lee YY. The Priming Effects of Mirror Visual Feedback on Bilateral Task Practice: A Randomized Controlled Study. Occup Ther Int. 2019 Nov 26;2019:3180306. doi: 10.1155/2019/3180306. eCollection 2019.
PubMed 31824233
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARTHEMIRS: Assessment of Brain Activation During Different Mirror Therapy Tasks Using fNIRS Technology
- ClinicalTrials.gov ID
- NCT04738851
- Acronym / sponsor ID
- ARTHEMIRS / CHRO 2020-14
- Conditions
- Healthy
- Keywords
- mirror therapy, near infrared spectroscopy, cerebral activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 4 Mar 2021 (actual)
- Study completion
- 4 Mar 2021 (actual)
- First posted
- 4 Feb 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 purpose of this study is to investigate the cerebral activation during Classic Mirror Therapy (TMC) and especially during Virtual Mirror Therapy (TMV) in healthy subjects. It seems that the precuneus is involved in the effectiveness of mirror therapy. One goal of this study is to determine if there is a better activation of the precuneus during TMV than during TMC. Others goals are to compare cerebral activation during three different tasks (TMV, TMC and a simple motor task), to study the intra-subjects reproducibility of the measurement and the correlation between cerebral activation and feelings of the participants about the efficacity of the tasks.
Detailed description
Mirror therapy is a rehabilitation technique that has been shown to be effective in restoring upper limb motor skills in patients with stroke. However, it comes up against certain constraints of clinical use such as installation difficulties or the obligation of symmetrical bilateral work. These constraints can be limited by the use of so-called 2nd generation virtual mirror therapy technologies. It is therefore likely that these new technologies will improve the feasibility and effectiveness of mirror therapy in rehabilitation. While the brain mechanisms involved in mirror therapy are not yet fully understood, the involvement of the precuneus has been demonstrated by a booming imaging method: fNIRS (functional Near Infra Red Spectroscopy). This method allows (like fMRI) to study cerebral neurovascular coupling. It is based on the fact that an activated region of the brain increases its local blood flow. Oxygenated hemoglobin (HbO) and deoxygenated (HbR) absorb infrared light and it is then possible to identify the cortical regions of the brain involved in a given task. This technique therefore makes it possible to study brain activation under more ecological conditions than fMRI and is therefore particularly suitable for exploring rehabilitation techniques.
This research aims to study and compare in healthy subjects, using a fNIRS apparatus, the brain regions involved in the performance of a classic mirror therapy task and a virtual mirror therapy task with the IVS3 (Intensive Visual Simulation) apparatus (Dessintey Technology).
The investigations will be carried out by the principal investigator or by specialized technicians from the neurology functional exploration department.
Each acquisition has a duration of 620 seconds, it begins with a rest period of 120 seconds, which corresponds to the baseline.
For each condition the movements are performed at a frequency of 0.5 Hz which seems to be the optimal frequency for observing cortical activation using a metronome. Each movement is therefore performed 10 times per block.
The order of placing the various conditions will be balanced. Between periods of movement, the subject is in a resting position for 30 seconds.
The "movement" and "rest" instructions are given at the start of each phase. The entire test will be repeated one week apart to assess the reproducibility of the measurements in healthy subjects.
The protocol has 3 conditions:
- A virtual TM task (TMV)
- A classic TM task (TMC)
- A control task (TC) Healthy subjects participating in the study will have two different acquisition times, each comprising 3 conditions.
After recruiting the subjects, the study investigator will check the inclusion and non-inclusion criteria.
If the subject can integrate the protocol, the two acquisition stages will then be scheduled one week apart.
On the day of the first acquisition, the subject will present to the neurology department at the time of his appointment.
The order of the 3 conditions will then be randomized to avoid potential biases linked to the sequence of conditions.
Then the fNIRS acquisition headset (Brite 24) will be installed by a specialized technician and the procurement instructions will be given.
The acquisition under the 3 conditions is then carried out: TC1, TMC1, TMV1 with a rest time of 10 minutes between each condition.
The subject's feelings after the TMC and TMV conditions will be evaluated using the visual analogue scale (VAS). 0 corresponding to a zero feeling and 10 to a very important feeling. The subject will be explained that the feeling could correspond to tingling sensations, a desire to mobilize the hand which is behind the mirror, a "disturbing", "bizarre" sensation.
The helmet is only removed at the end of the 3 spots The subject returns a week later for the 2nd acquisition phase during which the same acquisitions as during the 1st meeting are carried out and then participation in the study is terminated.
There will therefore be 6 tests for each healthy subject.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | Experimental | Other: Therapy Mirror taskVirtual mirror therapy task : TMV Classic mirror therapy task : TMC Control task :TC |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age:18 to 40
- Right handed
- No neurological disease
Key exclusion criteria (1 listed)
- Known allergy to components of the fNIRS device: neoprene
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 |
|---|---|---|
| Therapy Mirror taskThe protocol has 3 conditions: * A virtual TM task (TMV * A classic TM task (TMC) * A control task (TC) The order of the 3 conditions will then be randomized to avoid potential biases linked to the sequence of conditions. | Other | healthy volunteers |
Primary outcome
Compare the level of precuneus activation during conventional mirror therapy (TMC) and virtual mirror therapy (TMV)
Time frame: Day 0
Changes in the concentration of oxyhemoglobin and deoxyhemoglobin measured with fnirs device
8 secondary outcomes
Compare the level of activation of the precuneus during TMC and TC.
Time frame: Day 0
Compare the level of precuneus activation during TMV and TC.
Time frame: Day 0
Compare the level of activation of contralateral motor regions to visual feedback during TMC and TMV.
Time frame: Day 0
Compare the level of activation of the contralateral motor regions to visual feedback during TMV and TC.
Time frame: Day 0
Compare the level of activation of the contralateral motor regions to visual feedback during TMC and TC.
Time frame: Day 0
Evaluate the reproducibility of measurements
Time frame: Day 0
Evaluate the reproducibility of measurements
Time frame: Day 7
Compare the cortical regions involved during the different mirror therapy tasks and the feelings of the subjects.
Time frame: Day 0
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 12 May 2021.
- Background: PubMed 10376620Altschuler EL, Wisdom SB, Stone L, Foster C, Galasko D, Llewellyn DM, Ramachandran VS. Rehabilitation of hemiparesis after stroke with a mirror. Lancet. 1999 Jun 12;353(9169):2035-6. doi: 10.1016/s0140-6736(99)00920-4. No abstract available.
- Background: PubMed 28473763Bae SJ, Jang SH, Seo JP, Chang PH. The Optimal Speed for Cortical Activation of Passive Wrist Movements Performed by a Rehabilitation Robot: A Functional NIRS Study. Front Hum Neurosci. 2017 Apr 20;11:194. doi: 10.3389/fnhum.2017.00194. eCollection 2017.
- Background: PubMed 31805613Bai Z, Fong KNK, Zhang J, Hu Z. Cortical mapping of mirror visual feedback training for unilateral upper extremity: A functional near-infrared spectroscopy study. Brain Behav. 2020 Jan;10(1):e01489. doi: 10.1002/brb3.1489. Epub 2019 Dec 5.
- Background: PubMed 26409402Brunetti M, Morkisch N, Fritzsch C, Mehnert J, Steinbrink J, Niedeggen M, Dohle C. Potential determinants of efficacy of mirror therapy in stroke patients--A pilot study. Restor Neurol Neurosci. 2015;33(4):421-34. doi: 10.3233/RNN-140421.
- Background: PubMed 20392975Calautti C, Jones PS, Naccarato M, Sharma N, Day DJ, Bullmore ET, Warburton EA, Baron JC. The relationship between motor deficit and primary motor cortex hemispheric activation balance after stroke: longitudinal fMRI study. J Neurol Neurosurg Psychiatry. 2010 Jul;81(7):788-92. doi: 10.1136/jnnp.2009.190512. Epub 2010 Apr 14.
- Background: PubMed 31824406Chang CS, Lo YY, Chen CL, Lee HM, Chiang WC, Li PC. Alternative Motor Task-Based Pattern Training With a Digital Mirror Therapy System Enhances Sensorimotor Signal Rhythms Post-stroke. Front Neurol. 2019 Nov 22;10:1227. doi: 10.3389/fneur.2019.01227. eCollection 2019.
- Background: PubMed 30210873Darbois N, Guillaud A, Pinsault N. Do Robotics and Virtual Reality Add Real Progress to Mirror Therapy Rehabilitation? A Scoping Review. Rehabil Res Pract. 2018 Aug 19;2018:6412318. doi: 10.1155/2018/6412318. eCollection 2018.
- Background: PubMed 22510258Ferrari M, Quaresima V. A brief review on the history of human functional near-infrared spectroscopy (fNIRS) development and fields of application. Neuroimage. 2012 Nov 1;63(2):921-35. doi: 10.1016/j.neuroimage.2012.03.049. Epub 2012 Mar 28.
- Background: PubMed 14597303Giraux P, Sirigu A. Illusory movements of the paralyzed limb restore motor cortex activity. Neuroimage. 2003 Nov;20 Suppl 1:S107-11. doi: 10.1016/j.neuroimage.2003.09.024.
- Background: PubMed 25416737Harmsen WJ, Bussmann JB, Selles RW, Hurkmans HL, Ribbers GM. A Mirror Therapy-Based Action Observation Protocol to Improve Motor Learning After Stroke. Neurorehabil Neural Repair. 2015 Jul;29(6):509-16. doi: 10.1177/1545968314558598. Epub 2014 Nov 21.
- Background: PubMed 30863295Inagaki Y, Seki K, Makino H, Matsuo Y, Miyamoto T, Ikoma K. Exploring Hemodynamic Responses Using Mirror Visual Feedback With Electromyogram-Triggered Stimulation and Functional Near-Infrared Spectroscopy. Front Hum Neurosci. 2019 Feb 26;13:60. doi: 10.3389/fnhum.2019.00060. eCollection 2019.
- Background: PubMed 29060834Jihun Kim, Jaehyo Kim. Robot-assisted mirroring exercise as a physical therapy for hemiparesis rehabilitation. Annu Int Conf IEEE Eng Med Biol Soc. 2017 Jul;2017:4243-4246. doi: 10.1109/EMBC.2017.8037793.
- Individual participant dataSharing planned: No
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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.
Julien BONNAL principal investigator
CHR d'Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapy Mirror task in people with Healthy, run by Centre Hospitalier Régional d'Orléans 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 3 inclusion and 1 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 12 May 2021. 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?
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?
Compare the level of precuneus activation during conventional mirror therapy (TMC) and virtual mirror therapy (TMV) (time frame: Day 0). 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 NCT04738851, which also lists 16 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 12 May 2021.