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

NCT06344221 | Not Yet Recruiting DMC

• 1 other identifier: 2023-A00954-41
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Assessing haptic effect during another dexterity exercise with and without sensory feedback: the force control of the index

  1 day

• Assessing haptic effect during another dexterity exercise with and without sensory feedback: the rhythm capacity

  1 day

• Correlation between clinical assessment and haptic measure

  1 day

• Assessment of the feasibility of the haptic measures

  1 day

• Assessment of the benefits of the haptic measures

  1 day

Study Arms (3)

Young Healthy Controls

ACTIVE COMPARATOR

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

Healthy controls matched in age and sex with stroke patients

ACTIVE COMPARATOR

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

Chronic stroke patients

EXPERIMENTAL

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

Interventions

Dextrain Manipulandum and haptic feedback device DEVICE

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

Also known as: Transcranial Magnetic Stimulation

Chronic stroke patients; Healthy controls matched in age and sex with stroke patients; Young Healthy Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Contraindication to TMS (epilepsy, metal implants)

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead
• Paris Brain Institute (ICM): collaborator
• Centre Hospitalier Régional d'Orléans: collaborator

MeSH Terms

Conditions

Stroke; Paresis

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Guillaume Turc

  GHU Psychiatrie et Neurosciences de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Påvel Lindberg

CONTACT

+33140789244; pavel.lindberg@inserm.fr

Sabrina Lekcir

CONTACT

sabrina.lekcir@ghu-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: April 3, 2024
• Study Start: April 15, 2024
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share