Induced Motion Illusions Through Vision and Tendon Vibrations: Study of Interactions in Hemiplegic Subjects

Hemiplegia Clinical Trial

— OPTIVIBE  

Official title:

Induced Motion Illusions Through Vision and Tendon Vibrations: Study of Interactions in Hemiplegic Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04449328
• Other study ID #: 19CH113
• Secondary ID: 2019-A01673-54
• Status: Terminated
• Phase: N/A
• Start date: April 30, 2021
• Est. completion date: April 28, 2023

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: April 28, 2023
• Est. primary completion date: April 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia

Intervention

Device:
• Computerized Mirror Therapy (CMT)
Computerized Mirror Therapy (CMT) will be realizing by the device Intensive Visual Simulation 3 (IVS3). The patient looks on a screen in front of him, mirroring the movements made by his hand, while attempting to perform the same movement with his other hand.
• Tendon vibration
Transcutaneous vibrations are used. This device allows vibrations from 50 to 120 Hz with amplitude of 1 mm. This study the frequency used is 70 and 80 Hz.

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	subjective measure of the intensity of the perception of movements: change from baseline impression of movement at day 7	Measured impression of movement on conditions (visual and/or proprioceptive; yes/no/don't know)	Day: 0, 7
Primary	subjective measure of the intensity of the perception of movements: change from baseline nature of this impression at day 7	Measured nature of this impression of movement (flexion/extension)	Day: 0, 7
Primary	subjective measure of the intensity of the perception of movements: change from baseline intensity of the movement felt at day 7	Measured intensity of the movement felt by Visual Analogue Scale (VAS) results (0 = no sense of movement and 10 = like real movement.)	Day: 0, 7
Secondary	Objective measurement of the perceived movement angle reproduced without motor intention by the hemiplegic subjects with the healthy limb	Measured by Kinovea software.	Day: 0, 7
Secondary	Measurement of motor intention in hemiplegic subjects by experimental conditions	Measured by Visual Analogue Scale (VAS) results (0 = no sense of movement and 10 = like real movement).	Day: 0, 7
Secondary	To compare the Visual Analogue Scale (VAS) score according to the level of motor impairment	Level of motor impairment is measured by Medical Research Council (MRC) score. Medical Research Council (MRC) score evaluate motricity (0= paralyzed).	Day: 0
Secondary	To compare the Visual Analogue Scale (VAS) score with the Erasmus modified Nottingham Sensory Assessment (EmNSA) score	Erasmus modified Nottingham Sensory Assessment (EmNSA) score evaluated the level of sensory impairment.; The Erasmus modified Nottingham Sensory Assessment (EmNSA) includes 2 subscales: somatosensory score (min 0 and max 44) and stereognosis (min 0 and max 20) for left and right members.	Day: 0
Secondary	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	Measured by Kinovea software.	Day: 0, 7
Secondary	Brain activity according to different experimental conditions (with and without vibration or with and without visual illusion) in hemiplegic subjects.	Multi Channel EEG Acquisition System	Day: 0, 7