Study of Cerebral Activation During Different Rehabilitation Tasks of Lower Limb in Virtual Mirror Therapy in Healthy Subjects
NCT ID: NCT05743647
Last Updated: 2023-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
38 participants
OBSERVATIONAL
2023-02-20
2023-04-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
fNIRS Study of Effort-dependent Brain Activations During Pointing Movements of the Upper Limb in Post-stroke Patients and Healthy Subjects
NCT06116006
Mirror Therapy Rehabilitation for Motor Functional Neurological Disorders.
NCT04739176
Functional Neuroimaging of Postural Reconstruction
NCT01013727
Neurorehabilitation Using a Virtual Reality-based Mirror Therapy
NCT03329417
Motor Imagery and Rehabilitation of Orthopaedic Patients
NCT03370146
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The brain mechanisms involved in virtual mirror therapy are not yet fully understood. EEG (Electroencephalography) and fNIRS (functional Near Infra Red Spectroscopy) are two functional method that allows to study the cerebral cortex changes during different tasks (like fMRI).
These techniques therefore makes it possible to study brain activation under more ecological conditions than fMRI and are therefore particularly suitable for exploring rehabilitation techniques.
This research aims to study and compare in healthy subjects, using EEG and fNIRS, the brain regions involved in three tasks using a virtual mirror therapy device (IVS4 apparatus ; Dessintey, France) implying lower limb control.
The protocol has 3 conditions :
observation (OBS), observation and imagination (OBS-IM) and observation and realization (OBS-REAL).
The order of the 3 conditions will then be randomized to avoid potential biases linked to the sequence of conditions.
The EEG recording will used the 32 channels ENOBIO apparatus. The fNIRS will used the Brite MKII apparatus
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Young
40 right handed healthy subject aged between 18 and 40
Observation (OBS)
Subject is seated in a chair facing IVS4. He places his right lower under the screen. The flexion / extension movement of the ankle at a frequency of 0.5 Hz is then recorded. Then for the "mirror" effect the software reverses the recorded movement, the lower right limb becomes the lower left limb on the screen.
The subject only observe the movement on the screen during the recordings. The subject does not produce any movement.
Observation and imagination (OBS-IM)
Subject is seated in a chair facing IVS4. He places his right lower under the screen. The flexion / extension movement of the ankle at a frequency of 0.5 Hz is then recorded. Then for the "mirror" effect the software reverses the recorded movement, the lower right limb becomes the lower left limb on the screen.
The subject observe the movement but also imagine to realized it.
Observation and realization (OBS-REAL)
Subject is seated in a chair facing IVS4. He places his right lower under the screen. The flexion / extension movement of the ankle at a frequency of 0.5 Hz is then recorded. Then for the "mirror" effect the software reverses the recorded movement, the lower right limb becomes the lower left limb on the screen.
The subject observe the movement on the screen and realized it
Old
40 right handed healthy subject aged between 41 and 75
Observation (OBS)
Subject is seated in a chair facing IVS4. He places his right lower under the screen. The flexion / extension movement of the ankle at a frequency of 0.5 Hz is then recorded. Then for the "mirror" effect the software reverses the recorded movement, the lower right limb becomes the lower left limb on the screen.
The subject only observe the movement on the screen during the recordings. The subject does not produce any movement.
Observation and imagination (OBS-IM)
Subject is seated in a chair facing IVS4. He places his right lower under the screen. The flexion / extension movement of the ankle at a frequency of 0.5 Hz is then recorded. Then for the "mirror" effect the software reverses the recorded movement, the lower right limb becomes the lower left limb on the screen.
The subject observe the movement but also imagine to realized it.
Observation and realization (OBS-REAL)
Subject is seated in a chair facing IVS4. He places his right lower under the screen. The flexion / extension movement of the ankle at a frequency of 0.5 Hz is then recorded. Then for the "mirror" effect the software reverses the recorded movement, the lower right limb becomes the lower left limb on the screen.
The subject observe the movement on the screen and realized it
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Observation (OBS)
Subject is seated in a chair facing IVS4. He places his right lower under the screen. The flexion / extension movement of the ankle at a frequency of 0.5 Hz is then recorded. Then for the "mirror" effect the software reverses the recorded movement, the lower right limb becomes the lower left limb on the screen.
The subject only observe the movement on the screen during the recordings. The subject does not produce any movement.
Observation and imagination (OBS-IM)
Subject is seated in a chair facing IVS4. He places his right lower under the screen. The flexion / extension movement of the ankle at a frequency of 0.5 Hz is then recorded. Then for the "mirror" effect the software reverses the recorded movement, the lower right limb becomes the lower left limb on the screen.
The subject observe the movement but also imagine to realized it.
Observation and realization (OBS-REAL)
Subject is seated in a chair facing IVS4. He places his right lower under the screen. The flexion / extension movement of the ankle at a frequency of 0.5 Hz is then recorded. Then for the "mirror" effect the software reverses the recorded movement, the lower right limb becomes the lower left limb on the screen.
The subject observe the movement on the screen and realized it
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Sufficient command of the French language to understand the instructions
* No known neurological medical history
* With social security coverage
* Right-handed subjects with a laterality test of Edinburgh QL\> 40 (Oldfield 1971)
Exclusion Criteria
* Adults under guardianship
* Adults under guardianship
* Pregnant or breastfeeding women
* Subjects who have objected to participating in the study
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Régional d'Orléans
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pascal GIRAUX, Pr
Role: PRINCIPAL_INVESTIGATOR
CHU de Saint Etienne - Hôpital Bellevue
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU de Saint-Etienne
Saint-Etienne, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bartur G, Pratt H, Frenkel-Toledo S, Soroker N. Neurophysiological effects of mirror visual feedback in stroke patients with unilateral hemispheric damage. Brain Res. 2018 Dec 1;1700:170-180. doi: 10.1016/j.brainres.2018.09.003. Epub 2018 Sep 5.
Bonnal J, Monnet F, Le BT, Pila O, Grosmaire AG, Ozsancak C, Duret C, Auzou P. Relation between Cortical Activation and Effort during Robot-Mediated Walking in Healthy People: A Functional Near-Infrared Spectroscopy Neuroimaging Study (fNIRS). Sensors (Basel). 2022 Jul 25;22(15):5542. doi: 10.3390/s22155542.
Borges LR, Fernandes AB, Melo LP, Guerra RO, Campos TF. Action observation for upper limb rehabilitation after stroke. Cochrane Database Syst Rev. 2018 Oct 31;10(10):CD011887. doi: 10.1002/14651858.CD011887.pub2.
Coll MP, Press C, Hobson H, Catmur C, Bird G. Crossmodal Classification of Mu Rhythm Activity during Action Observation and Execution Suggests Specificity to Somatosensory Features of Actions. J Neurosci. 2017 Jun 14;37(24):5936-5947. doi: 10.1523/JNEUROSCI.3393-16.2017. Epub 2017 May 30.
Fox NA, Bakermans-Kranenburg MJ, Yoo KH, Bowman LC, Cannon EN, Vanderwert RE, Ferrari PF, van IJzendoorn MH. Assessing human mirror activity with EEG mu rhythm: A meta-analysis. Psychol Bull. 2016 Mar;142(3):291-313. doi: 10.1037/bul0000031. Epub 2015 Dec 21.
Macuga KL, Frey SH. Neural representations involved in observed, imagined, and imitated actions are dissociable and hierarchically organized. Neuroimage. 2012 Feb 1;59(3):2798-807. doi: 10.1016/j.neuroimage.2011.09.083. Epub 2011 Oct 8.
Adham A, Le BT, Bonnal J, Bessaguet H, Ojardias E, Giraux P, Auzou P. Neural basis of lower-limb visual feedback therapy: an EEG study in healthy subjects. J Neuroeng Rehabil. 2024 Jul 8;21(1):114. doi: 10.1186/s12984-024-01408-8.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHRO-2022-06
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.