Clinical trial NCT04449328: Induced Motion Illusions Through Vision and Tendon Vibrations: Study of Interactions in Hemiplegic Subjects
Official title: Induced Motion Illusions Through Vision and Tendon Vibrations: Study of Interactions in Hemiplegic Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hemiplegia
Keywords: Computerized Mirror Therapy (CMT)
Intensive Visual Simulation3 (IVS3)
Vibration
Vibrasens
Upper limb rehabilitation
Stroke
Hemiplegic
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2020-06-26
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Two movement illusion techniques can currently be used in clinical practice for motor rehabilitation after stroke hemiplegia: visual illusion (mirror therapy) and proprioceptive illusion (tendon vibration). Mirror therapy, in its computerized version (IVS3, Dessintey, Saint-Etienne, France), is based on the substitution of the deficient visual feedback by a visual feedback of a correctly realized movement. The proprioceptive illusion is based on the external application of a vibrator on muscle tendons at a frequency between 50 and 120 Hz. These two techniques are currently used independently. They are, in theory, complementary and additive. No study has described the combinatorial properties of the illusions generated by these 2 techniques in hemiplegic subjects and healthy subjects.

Detailed description: The study hypothesis is that the administration of mirror therapy together with vibration will increase the perception of movement in a subjective scale.

Eligibility criteria: Inclusion Criteria:

Hemiplegic subjects :

* Male or female
* Aged 18 to 70 years,
* First ischemic or hemorrhagic stroke causing hemiplegic
* Having signed the written consent
* Affiliated or entitled to a social security scheme

Healthy subjects :

* Male or female, aged 18 to 70 years,
* Matched in sex, age and laterally with hemiplegic subjects
* Having signed the written consent
* Affiliated or entitled to a social security scheme

Exclusion Criteria:

Hemiplegic subjects :

* With complete lesion of the primary motor cortex
* With an addiction to alcohol or drugs
* With psychiatric illness, cognitive impairment, uncontrolled disease/epilepsy, malignant illness severe kidney or lung disease
* With history of associated general disabling disease
* With cerebellar syndrome
* With clinical brain stem involvement
* Under legal protection
* Pregnant or breastfeeding women

Healthy subjects :

* Neurological, cardiovascular, musculoskeletal diseases
* Taking medication that can affect attention
* Unable to understand instructions of the study
* Under legal protection
* Pregnant or breastfeeding women

Primary outcomes:
measure: subjective measure of the intensity of the perception of movements: change from baseline impression of movement at day 7
timeFrame: Day: 0, 7
measure: subjective measure of the intensity of the perception of movements: change from baseline nature of this impression at day 7
timeFrame: Day: 0, 7
measure: subjective measure of the intensity of the perception of movements: change from baseline intensity of the movement felt at day 7
timeFrame: Day: 0, 7
Secondary outcomes:
measure: Objective measurement of the perceived movement angle reproduced without motor intention by the hemiplegic subjects with the healthy limb
timeFrame: Day: 0, 7
measure: Measurement of motor intention in hemiplegic subjects by experimental conditions
timeFrame: Day: 0, 7
measure: To compare the Visual Analogue Scale (VAS) score according to the level of motor impairment
timeFrame: Day: 0
measure: To compare the Visual Analogue Scale (VAS) score with the Erasmus modified Nottingham Sensory Assessment (EmNSA) score
timeFrame: Day: 0
measure: Intensity of the perception of movements using a visual analogue scale and the objective measurement of perceived movement angle reproduced by the healthy subjects with the vibrated arm
timeFrame: Day: 0, 7
measure: Brain activity according to different experimental conditions (with and without vibration or with and without visual illusion) in hemiplegic subjects.
timeFrame: Day: 0, 7
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Pascal GIRAUX, PhD
role: PRINCIPAL_INVESTIGATOR
References: