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

Not Applicable

Not yet recruiting

• Conditions: Stroke; Sensory Integration Dysfunction; Vibration; Disorder; Upper Extremity Paresis; Manual Dexterity
• Interventions: Device: Dextrain Manipulandum and haptic feedback device

• Registration Number: NCT06344221
• Lead Sponsor: Centre Hospitalier St Anne

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).

Study Timeline

• Study First Submitted: 2024-02-16
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-27
• Last Update Submitted: 2024-03-27
• Study First Posted: 2024-04-03
• Last Update Posted: 2024-04-03
• Study Start: 2024-04-15
• Primary Completion: 2024-07-15
• Study Completion: 2024-07-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

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Exclusion Criteria

• Contraindication to TMS (epilepsy, metal implants)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy controls matched in age and sex with stroke patients	Dextrain Manipulandum and haptic feedback device	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.
Young Healthy Controls	Dextrain Manipulandum and haptic feedback device	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.
Chronic stroke patients	Dextrain Manipulandum and haptic feedback device	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.

Primary Outcome Measures

Name	Time	Method
Assessing haptic effect during a dexterity exercise with and without sensory feedback: finger independence	1 day	Comparison of finger independence, assessed with the Dextrain Manipulandum tool with and without sensory feedback (vibrations on the fingers). Measurement of the difference in motor performance between the condition with and without vibrations.

Secondary Outcome Measures

Name	Time	Method
Assessment of the feasibility of the haptic measures	1 day	Assessment of Intrinsic motivation survey to quantify the feasibility of the haptic device. The score will be from 0 to 7, 7 meaning an excellent motivation of the patient to use the device
Assessment of the benefits of the haptic measures	1 day	Assessment of User Engagement scale to quantify the benefits perceived by the subject in relation to the haptic device. The score will be from 0 to 10, 10 meaning an excellent interest of the patient for the device
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	1 day	The same examinator will assess haptic effect at the beginning and at the end of the session
Assessment of the impact of age on the dexterity performances (Finger independence, force control of the index and rhythm capacity)	1 day	Comparison of the haptic effect (difference in motor performance between the conditions with and without vibrations on the fingers) between the groups of young healthy subjects and the group of healthy subjects of comparable age and sex to chronic stroke patients
Assessing haptic effect during another dexterity exercise with and without sensory feedback: the force control of the index	1 day	Comparison of finger force control, assessed with the dextrain manipulandum tool with and without sensory feedback (vibrations on the fingers). Measurement of the difference in motor performance between the condition with and without vibrations.
Correlation between clinical assessment and haptic measure	1 day	Research the link between haptic feedback deficits and motor disorders of manual dexterity
Assessing haptic effect during another dexterity exercise with and without sensory feedback: the rhythm capacity	1 day	Comparison of rhythm capacity, assess with the dextrain manipulandum tool with and without sensory feedback (vibrations on the fingers). Measurement of the difference in motor performance between the condition with and without vibrations.
Transcranial magnetic stimulation (TMS)	1 day	Difference in cortical excitability in the anticipatory phase of force generation with the index finger between conditions without and with vibro-tactile stimulation
Measurement of the manual dexterity facilitation between tactile (haptic device with vibrations on the fingers) and auditory feedback (sounds during the dexterity tasks)	1 day	To compare the effect of tactile (vibrations on the fingers during dexterity assessments) modality facilitation versus auditory feedback on dexterity (finger independence, force control of the index and rhythm capacity) in stroke patients, young healthy subjects and healthy subjects of comparable age and sex to chronic stroke patients