Integration and Interactions Between Visual and Proprioceptive Feedbacks (OptiVis)

Study of the Integration and Interactions Between Visual and Proprioceptive Feedbacks in Hemiplegic Patients

Mental imagery is a rehabilitation technique for stroke patients, involving the mental representation of movement. Recent technical advancements have enabled the use of visual, proprioceptive, and mixed feedback to enhance motor stimulation. Currently, all post-stroke patients receive these techniques indiscriminately. This study aims to demonstrate differences in the integration of visual and proprioceptive feedback in stroke patients and understand the determinants based on the affected brain area.

Patients with motor disabilities will perform motor imagery tasks with various feedback types while their cortical activity is recorded using EEG. EEG data for each type of feedback will be correlated with the lesion area in order to better understand the ongoing mechanisms.

Study Overview

• Status: Recruiting
• Conditions: Hemiparetic Stroke
• Intervention / Treatment: Device: Computerized mirror therapy (IVS3) + Tendon vibration (Vibramoov)

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diana RIMAUD, Doctor of Science; Phone Number: 33 0477120467; Email: diana.rimaud@chu-st-etienne.fr
• Study Contact Backup: Name: Ahmed Adham, Md; Phone Number: 33 04 77 12 91 14; Email: ahmed.adham@chu-st-etienne.fr

Study Locations

• France
  • France
    • Saint-Etienne, France, France, 42055
      • Recruiting
      • CHU Saint-Etienne
      • Sub-Investigator: Pascal Giraux, Md
      • Contact: Diana RIMAUD, Doctor of Science; Phone Number: 33 0477120467; Email: diana.rimaud@chu-st-etienne.fr
      • Principal Investigator: Ahmed ADHAM, Md

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Hemiplegic subjects : Male or female, aged 18 to 80 years, first ischemic or hemorrhagic stroke, having signed the written consent and affiliated or entitled to a social security scheme

Exclusion Criteria:

• Severe cognitive impairment, severe Aphasia or severe neglect that impair ability to understand instructions or to execute tasks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Computerized mirror therapy (IVS3) + Tendon vibration (Vibramoov); During these sessions, they will perform a wrist extension task 30 times, under four different rehabilitation conditions (in randomized order), with pauses between conditions: Movement without feedback; Movement with visual feedback; Movement and vibratory feedback; Movement with combined visual and vibratory feedback. Visual and vibratory feedback is provided using the IVS3 and Vibramoov Physio devices.

Device: Computerized mirror therapy (IVS3) + Tendon vibration (Vibramoov); Visit 1 : Followed by 30 movements of Paretic arm wrist extension with 4 randomized experimental conditions (Vision alone, Vibration alone, Vision + Vibration, No feedback), with EEG monitoring. Measurement of movement perception feeling for each condition. Visit 2 : 30 movements of Paretic arm wrist extension with 4 randomized experimental conditions (Vision alone, Vibration alone, Vision + Vibration, No feedback), with EEG monitoring. Measurement of movement perception feeling for each condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG beta desynchronization	Differences in the EEG beta desynchronization over motor-cortex across the types of feedbacks.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alpha Band	Alpha Band desynchronization over motor cortex	Day 1
Occipital alpha band	Occipital alpha band modulations	Day 1
Beta rebound	Beta rebound (Event related synchronization)	Day 1
Parietal beta-band	Parietal beta-band desynchronization	Day 1
Perception of movements	The intensity of the perception of movements using a visual analogue scale and the objective measurement of perceived movement angle reproduced by the healthy hand's and Visual analogic scale	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Ahmed Adham, Md, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: April 15, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Stroke; Vibration; hemiplegic; Upper limb rehabilitation; Computerize mirror
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 24CH167; 2024-A02163-44 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The study is monocentric

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No