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

Centre Hospitalier St Anne

Status: Not yet enrolling

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

Treatments: Device: Dextrain Manipulandum and haptic feedback device

Study type: Interventional

Funder types: Other

Identifiers

NCT06344221

2023-A00954-41

Details and patient eligibility

About

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.

Full 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).

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Young Healthy Controls

Active Comparator group

Description:

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.

Treatment:

Device: Dextrain Manipulandum and haptic feedback device

Healthy controls matched in age and sex with stroke patients

Active Comparator group

Description:

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.

Treatment:

Device: Dextrain Manipulandum and haptic feedback device

Chronic stroke patients

Experimental group

Description:

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.

Treatment:

Device: Dextrain Manipulandum and haptic feedback device