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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Upper Extremity Paresis; Manual Dexterity; Sensory Integration Dysfunction; Vibration; Disorder
• Intervention / Treatment: Device: Dextrain Manipulandum and haptic feedback device

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pavel Lindberg; Phone Number: +33140789244; Email: pavel.lindberg@inserm.fr
• Study Contact Backup: Name: Sabrina Lekcir; Email: sabrina.lekcir@ghu-paris.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Dextrain Manipulandum and haptic feedback device; Assessment of key components of manual dexterity in addition to vibrotactile stimulation on the fingers and wrist.; Other Names: Transcranial Magnetic Stimulation
Active Comparator: 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.	Device: Dextrain Manipulandum and haptic feedback device; Assessment of key components of manual dexterity in addition to vibrotactile stimulation on the fingers and wrist.; Other Names: Transcranial Magnetic Stimulation
Experimental: 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.	Device: Dextrain Manipulandum and haptic feedback device; Assessment of key components of manual dexterity in addition to vibrotactile stimulation on the fingers and wrist.; Other Names: Transcranial Magnetic Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing haptic effect during a dexterity exercise with and without sensory feedback: finger independence	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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing haptic effect during another dexterity exercise with and without sensory feedback: the force control of the index	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.	1 day
Assessing haptic effect during another dexterity exercise with and without sensory feedback: the rhythm capacity	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.	1 day
Correlation between clinical assessment and haptic measure	Research the link between haptic feedback deficits and motor disorders of manual dexterity	1 day
Assessment of the feasibility of the haptic measures	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	1 day
Assessment of the benefits of the haptic measures	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	1 day
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	The same examinator will assess haptic effect at the beginning and at the end of the session	1 day
Assessment of the impact of age on the dexterity performances (Finger independence, force control of the index and rhythm capacity)	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	1 day
Measurement of the manual dexterity facilitation between tactile (haptic device with vibrations on the fingers) and auditory feedback (sounds during the dexterity tasks)	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	1 day
Transcranial magnetic stimulation (TMS)	Difference in cortical excitability in the anticipatory phase of force generation with the index finger between conditions without and with vibro-tactile stimulation	1 day

Collaborators and Investigators

• Sponsor: Centre Hospitalier St Anne
• Collaborators: Centre Hospitalier Régional d'Orléans; Brain & Spine Institute (ICM)
• Investigators: Principal Investigator: Guillaume Turc, GHU Psychiatrie et Neurosciences de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2024
• Primary Completion (Estimated): July 15, 2024
• Study Completion (Estimated): July 15, 2024

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Paresis
• Other Study ID Numbers: 2023-A00954-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No