Clinical trial NCT06344221: Post-stroke Haptic Feedback Use Deficit: A Comparative and Reliability Study
Official title: Post-stroke Haptic Feedback Use Deficit: A Comparative and Reliability Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Upper Extremity Paresis
Manual Dexterity
Sensory Integration Dysfunction
Vibration; Disorder
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
Collaborators: name: Paris Brain Institute (ICM)
name: Centre Hospitalier Régional d'Orléans
First posted: 2024-04-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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).

Eligibility criteria: Inclusion Criteria for healthy controls:

* 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

Inclusion Criteria for chronic stroke patients:

* 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)

Primary outcomes:
measure: Assessing haptic effect during a dexterity exercise with and without sensory feedback: finger independence
timeFrame: 1 day
Secondary outcomes:
measure: Assessing haptic effect during another dexterity exercise with and without sensory feedback: the force control of the index
timeFrame: 1 day
measure: Assessing haptic effect during another dexterity exercise with and without sensory feedback: the rhythm capacity
timeFrame: 1 day
measure: Correlation between clinical assessment and haptic measure
timeFrame: 1 day
measure: Assessment of the feasibility of the haptic measures
timeFrame: 1 day
measure: Assessment of the benefits of the haptic measures
timeFrame: 1 day
measure: Study the test re-test reliability of the haptic device by comparing the haptic effect on dexterity assessed at the beginning and end of the session by the same evaluator
timeFrame: 1 day
measure: Assessment of the impact of age on the dexterity performances (Finger independence, force control of the index and rhythm capacity)
timeFrame: 1 day
measure: Measurement of the manual dexterity facilitation between tactile (haptic device with vibrations on the fingers) and auditory feedback (sounds during the dexterity tasks)
timeFrame: 1 day
measure: Transcranial magnetic stimulation (TMS)
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: GHU Psychiatrie et Neurosciences de Paris
name: Guillaume Turc
role: PRINCIPAL_INVESTIGATOR
References: