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

NCT04449328 | Terminated

• 2 other identifiers: 19CH1132019-A01673-54
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegia

Keywords

Computerized Mirror Therapy (CMT); Intensive Visual Simulation3 (IVS3); Vibration; Vibrasens; Upper limb rehabilitation; Stroke; Hemiplegic

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• Objective measurement of the perceived movement angle reproduced without motor intention by the hemiplegic subjects with the healthy limb

  Day: 0, 7

• Measurement of motor intention in hemiplegic subjects by experimental conditions

  Day: 0, 7

• To compare the Visual Analogue Scale (VAS) score according to the level of motor impairment

  Day: 0

• To compare the Visual Analogue Scale (VAS) score with the Erasmus modified Nottingham Sensory Assessment (EmNSA) score

  Day: 0

• 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

  Day: 0, 7

Study Arms (2)

Patient with first stroke causing hemiplegic

EXPERIMENTAL

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.

Device: Computerized Mirror Therapy (CMT); Device: Tendon vibration

healthy subjects

SHAM COMPARATOR

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.

Device: Computerized Mirror Therapy (CMT); Device: Tendon vibration

Interventions

Computerized Mirror Therapy (CMT) DEVICE

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.

Also known as: Intensive Visual Simulation3 (IVS3), Dessintey, Saint Etienne, France

Patient with first stroke causing hemiplegic; healthy subjects

Tendon vibration DEVICE

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.

Also known as: Vibrasens, VB115, Techno Concept, France

Patient with first stroke causing hemiplegic; healthy subjects

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, France

Location

Related Publications (1)

• Adham A, Bessaguet H, Struber L, Rimaud D, Ojardias E, Giraux P. Distinct and additive effects of visual and vibratory feedback for motor rehabilitation: an EEG study in healthy subjects. J Neuroeng Rehabil. 2024 Sep 12;21(1):158. doi: 10.1186/s12984-024-01453-3.

  PMID: 39267092 DERIVED

MeSH Terms

Conditions

Hemiplegia; Stroke

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pascal GIRAUX, PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 26, 2020
• Study Start: April 30, 2021
• Primary Completion: April 25, 2023
• Study Completion: April 28, 2023
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)