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

Primary Purpose

Hemiplegia

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Computerized Mirror Therapy (CMT)
Tendon vibration
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hemiplegia focused on measuring Computerized Mirror Therapy (CMT), Intensive Visual Simulation3 (IVS3), Vibration, Vibrasens, Upper limb rehabilitation, Stroke, Hemiplegic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Patient with first stroke causing hemiplegic

healthy subjects

Arm Description

Patient with first stroke causing hemiplegic will be included. They will have Computerized Mirror Therapy (CMT) associated at tendon vibration: Visit 1: wrist flexion (right and left arms) with 5 randomized experimental conditions (vision+vibration, vision alone, vibration alone, static image+vibration, vision of extension+vibration(incongruence)) Visit 2 (1 week later): wrist extension (right and left arms) with 5 randomized experimental conditions (vision+vibration, vision alone, vibration alone, static image+vibration, vision of flexion+vibration (incongruence)) These conditions will be recording by the Kinovea software, which allows the measurement of angles and amplitudes.

Healthy subjects will be included. They will have Computerized Mirror Therapy (CMT) associated at tendon vibration: Visit 1: wrist flexion (right and left arms) with 5 randomized experimental conditions (vision+vibration, vision alone, vibration alone, static image+vibration, vision of extension+vibration(incongruence)) Visit 2 (1 week later): wrist extension (right and left arms) with 5 randomized experimental conditions (vision+vibration, vision alone, vibration alone, static image+vibration, vision of flexion+vibration (incongruence)) These conditions will be recording by the Kinovea software, which allows the measurement of angles and amplitudes.

Outcomes

Primary Outcome Measures

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)
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)
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.)

Secondary Outcome Measures

Objective measurement of the perceived movement angle reproduced without motor intention by the hemiplegic subjects with the healthy limb
Measured by Kinovea software.
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).
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).
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.
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.
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

Full Information

First Posted
June 22, 2020
Last Updated
May 26, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT04449328
Brief Title
Induced Motion Illusions Through Vision and Tendon Vibrations: Study of Interactions in Hemiplegic Subjects
Acronym
OPTIVIBE
Official Title
Induced Motion Illusions Through Vision and Tendon Vibrations: Study of Interactions in Hemiplegic Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
lack of inclusion
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
April 25, 2023 (Actual)
Study Completion Date
April 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia
Keywords
Computerized Mirror Therapy (CMT), Intensive Visual Simulation3 (IVS3), Vibration, Vibrasens, Upper limb rehabilitation, Stroke, Hemiplegic

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient with first stroke causing hemiplegic
Arm Type
Experimental
Arm Description
Patient with first stroke causing hemiplegic will be included. They will have Computerized Mirror Therapy (CMT) associated at tendon vibration: Visit 1: wrist flexion (right and left arms) with 5 randomized experimental conditions (vision+vibration, vision alone, vibration alone, static image+vibration, vision of extension+vibration(incongruence)) Visit 2 (1 week later): wrist extension (right and left arms) with 5 randomized experimental conditions (vision+vibration, vision alone, vibration alone, static image+vibration, vision of flexion+vibration (incongruence)) These conditions will be recording by the Kinovea software, which allows the measurement of angles and amplitudes.
Arm Title
healthy subjects
Arm Type
Sham Comparator
Arm Description
Healthy subjects will be included. They will have Computerized Mirror Therapy (CMT) associated at tendon vibration: Visit 1: wrist flexion (right and left arms) with 5 randomized experimental conditions (vision+vibration, vision alone, vibration alone, static image+vibration, vision of extension+vibration(incongruence)) Visit 2 (1 week later): wrist extension (right and left arms) with 5 randomized experimental conditions (vision+vibration, vision alone, vibration alone, static image+vibration, vision of flexion+vibration (incongruence)) These conditions will be recording by the Kinovea software, which allows the measurement of angles and amplitudes.
Intervention Type
Device
Intervention Name(s)
Computerized Mirror Therapy (CMT)
Other Intervention Name(s)
Intensive Visual Simulation3 (IVS3), Dessintey, Saint Etienne, France
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Tendon vibration
Other Intervention Name(s)
Vibrasens, VB115, Techno Concept, France
Intervention Description
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.
Primary Outcome Measure Information:
Title
subjective measure of the intensity of the perception of movements: change from baseline impression of movement at day 7
Description
Measured impression of movement on conditions (visual and/or proprioceptive; yes/no/don't know)
Time Frame
Day: 0, 7
Title
subjective measure of the intensity of the perception of movements: change from baseline nature of this impression at day 7
Description
Measured nature of this impression of movement (flexion/extension)
Time Frame
Day: 0, 7
Title
subjective measure of the intensity of the perception of movements: change from baseline intensity of the movement felt at day 7
Description
Measured intensity of the movement felt by Visual Analogue Scale (VAS) results (0 = no sense of movement and 10 = like real movement.)
Time Frame
Day: 0, 7
Secondary Outcome Measure Information:
Title
Objective measurement of the perceived movement angle reproduced without motor intention by the hemiplegic subjects with the healthy limb
Description
Measured by Kinovea software.
Time Frame
Day: 0, 7
Title
Measurement of motor intention in hemiplegic subjects by experimental conditions
Description
Measured by Visual Analogue Scale (VAS) results (0 = no sense of movement and 10 = like real movement).
Time Frame
Day: 0, 7
Title
To compare the Visual Analogue Scale (VAS) score according to the level of motor impairment
Description
Level of motor impairment is measured by Medical Research Council (MRC) score. Medical Research Council (MRC) score evaluate motricity (0= paralyzed).
Time Frame
Day: 0
Title
To compare the Visual Analogue Scale (VAS) score with the Erasmus modified Nottingham Sensory Assessment (EmNSA) score
Description
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.
Time Frame
Day: 0
Title
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
Description
Measured by Kinovea software.
Time Frame
Day: 0, 7
Title
Brain activity according to different experimental conditions (with and without vibration or with and without visual illusion) in hemiplegic subjects.
Description
Multi Channel EEG Acquisition System
Time Frame
Day: 0, 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal GIRAUX, PhD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Saint-Etienne
City
Saint-Étienne
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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