Post-stroke Haptic Feedback Use Deficit: A Comparative and Reliability Study

NCT ID: NCT06344221

Last Updated: 2024-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-15

Study Completion Date

2024-07-15

Brief Summary

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The aim of this comparative and reliability study is to highlight a deficit in the use of vibrotactile sensory feedback (haptic effect) in the planning and execution of fine manual dexterity movements after stroke. The investigators will include 3 groups of subjects, 1 group of young healthy subjects, 1 of older subjects matched in age and sex to the group of chronic stroke patients. Participants will take part in clinical tests of fine motor skills and sensitivity and will use a device to assess the key components of manual dexterity, to which vibrotactile sensors will be added. If they so wish, participants will be able to take part in a transcranial magnetic stimulation (TMS) study to assess the facilitation of cortical excitability due to the haptic effect.

Detailed Description

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Firstly, the investigators would like to carry out a study into the validity of measuring haptic deficits using vibro-tactile sensors positioned on the hands of chronic stroke patients and young and elderly healthy subjects. They believe that identifying the haptic deficit using a simple and rapid method, in combination with motor training, could make it possible to improve the prediction of recovery and personalise the rehabilitation of manual dexterity deficits after stroke. They will also compare the effect of tactile feedback with that of auditory feedback in order to study the specificity of the effect of this feedback on manual dexterity. In the second part, to better understand this and to study the cortical mechanisms involved in sensory-motor integration, the investigators propose to measure the haptic effect on cortical excitability in stroke patients and healthy subjects using Transcranial Magnetic Stimulation (TMS).

Conditions

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Stroke Upper Extremity Paresis Manual Dexterity Sensory Integration Dysfunction Vibration; Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Young Healthy Controls

The 3 groups, made up of participants with different pathologies and ages, will receive the same intervention (clinical motor and sensory tests and optional TMS). We are studying the difference in results between these groups.

Group Type ACTIVE_COMPARATOR

Dextrain Manipulandum and haptic feedback device

Intervention Type DEVICE

Assessment of key components of manual dexterity in addition to vibrotactile stimulation on the fingers and wrist.

Healthy controls matched in age and sex with stroke patients

The 3 groups, made up of participants with different pathologies and ages, will receive the same intervention (clinical motor and sensory tests and optional TMS). We are studying the difference in results between these groups.

Group Type ACTIVE_COMPARATOR

Dextrain Manipulandum and haptic feedback device

Intervention Type DEVICE

Assessment of key components of manual dexterity in addition to vibrotactile stimulation on the fingers and wrist.

Chronic stroke patients

The 3 groups, made up of participants with different pathologies and ages, will receive the same intervention (clinical motor and sensory tests and optional TMS). We are studying the difference in results between these groups.

Group Type EXPERIMENTAL

Dextrain Manipulandum and haptic feedback device

Intervention Type DEVICE

Assessment of key components of manual dexterity in addition to vibrotactile stimulation on the fingers and wrist.

Interventions

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Dextrain Manipulandum and haptic feedback device

Assessment of key components of manual dexterity in addition to vibrotactile stimulation on the fingers and wrist.

Intervention Type DEVICE

Other Intervention Names

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Transcranial Magnetic Stimulation

Eligibility Criteria

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Inclusion Criteria

* between 18 and 40 years old
* or age and sex match with chronic stroke patients
* Ability to perform motor, cognitive (MOCA score ≥26/30) and sensory assessment


* More than 18 years old
* Ability to perform motor, cognitive (MOCA score ≥26/30) and sensory assessment
* First symptomatic stroke more than 6 months ago
* Upper limb paresis (≤4/5 on the MRC scale)
* Feel ≥3/6 touch on the index and thumb fingers
* Box and Blocks test score between 1 and 54 blocks / min

Exclusion Criteria

* Contraindication to TMS (epilepsy, metal implants)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Paris Brain Institute (ICM)

OTHER

Sponsor Role collaborator

Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role collaborator

Centre Hospitalier St Anne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume Turc

Role: PRINCIPAL_INVESTIGATOR

GHU Psychiatrie et Neurosciences de Paris

Central Contacts

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Påvel Lindberg

Role: CONTACT

+33140789244

Sabrina Lekcir

Role: CONTACT

Other Identifiers

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2023-A00954-41

Identifier Type: -

Identifier Source: org_study_id

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