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

NCT ID: NCT04449328

Last Updated: 2023-05-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2023-04-28

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.

Conditions

Hemiplegia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patient with first stroke causing hemiplegic

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.

Group Type: EXPERIMENTAL

Computerized Mirror Therapy (CMT)

Intervention Type: 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.

Tendon vibration

Intervention Type: 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.

healthy subjects

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.

Group Type: SHAM_COMPARATOR

Computerized Mirror Therapy (CMT)

Intervention Type: 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.

Tendon vibration

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

Intensive Visual Simulation3 (IVS3), Dessintey, Saint Etienne, France; Vibrasens, VB115, Techno Concept, France

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascal GIRAUX, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

CHU de Saint-Etienne

Saint-Etienne, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 39267092 (View on PubMed)

Other Identifiers

2019-A01673-54

Identifier Type: OTHER

Identifier Source: secondary_id

19CH113

Identifier Type: -

Identifier Source: org_study_id