NCT06931509

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
24mo left

Started Nov 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Nov 2025Apr 2028

First Submitted

Initial submission to the registry

March 25, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 17, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

November 25, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

2.4 years

First QC Date

March 25, 2025

Last Update Submit

December 1, 2025

Conditions

Hemiparetic Stroke

Keywords

Computerize mirrorVibrationUpper limb rehabilitationStrokehemiplegic

Outcome Measures

Primary Outcomes (1)

  • EEG beta desynchronization

    Differences in the EEG beta desynchronization over motor-cortex across the types of feedbacks.

    Day 1

Secondary Outcomes (5)

  • Alpha Band

    Day 1

  • Occipital alpha band

    Day 1

  • Beta rebound

    Day 1

  • Parietal beta-band

    Day 1

  • Perception of movements

    Day 1

Study Arms (1)

Computerized mirror therapy (IVS3) + Tendon vibration (Vibramoov)

EXPERIMENTAL

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)

Interventions

Computerized mirror therapy (IVS3) + Tendon vibration (Vibramoov)DEVICE

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.

Computerized mirror therapy (IVS3) + Tendon vibration (Vibramoov)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France, 42055, France

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ahmed Adham, Md

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Rimaud, doctor of science

CONTACT

0477120467Diana.Rimaud@chu-st-etienne.fr

Ahmed Adham, Md

CONTACT

04 77 12 91 14ahmed.adham@chu-st-etienne.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2025

First Posted

April 17, 2025

Study Start

November 25, 2025

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2028

Last Updated

December 5, 2025

Record last verified: 2025-12

Locations

FR(1)