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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-20

Study Completion Date

2023-04-14

Brief Summary

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The purpose of this study is to investigate the cerebral activation during visual motor simulation in healthy subjects in 3 conditions: observation (OBS), observation and imagination (OBS-IM) and observation and realization (OBS-REAL). The investigators goal is to compare cerebral activation during the three different tasks using EEG and fNIRS.

Detailed Description

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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.

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

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Young

40 right handed healthy subject aged between 18 and 40

Observation (OBS)

Intervention Type DEVICE

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)

Intervention Type DEVICE

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)

Intervention Type DEVICE

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)

Intervention Type DEVICE

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)

Intervention Type DEVICE

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)

Intervention Type DEVICE

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

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects aged 18 to 75 years
* 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

* Minor subjects
* Adults under guardianship
* Adults under guardianship
* Pregnant or breastfeeding women
* Subjects who have objected to participating in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascal GIRAUX, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint Etienne - Hôpital Bellevue

Locations

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CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 30194016 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35898041 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30380586 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28559380 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26689088 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22005592 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38978051 (View on PubMed)

Other Identifiers

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CHRO-2022-06

Identifier Type: -

Identifier Source: org_study_id

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