StrokeHapticSNCT06344221
Post-stroke Haptic Feedback Use Deficit: A Comparative and Reliability Study
A study testing Dextrain Manipulandum and haptic feedback device in people with Stroke and Upper Extremity Paresis, run by Centre Hospitalier St Anne.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Upper Extremity Paresis, Manual Dexterity
- What is being tested?
- Dextrain Manipulandum and haptic feedback device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2024to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Contraindication to TMS (epilepsy, metal implants)
Trial locations and contacts
No sites are listed yet.
Sabrina Lekcir contact
About this study
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.
Read the 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).
- Conditions
- Stroke, Upper Extremity Paresis, Manual Dexterity, Sensory Integration Dysfunction, Vibration; Disorder
- Being tested
- Dextrain Manipulandum and haptic feedback device
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrain Manipulandum and haptic feedback deviceDevice
Also called Transcranial Magnetic Stimulation
Assessment of key components of manual dexterity in addition to vibrotactile stimulation on the fingers and wrist.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Dextrain Manipulandum and haptic feedback device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (9)
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.
Measured: 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.
Measured: 1 day
Correlation between clinical assessment and haptic measure
Research the link between haptic feedback deficits and motor disorders of manual dexterity
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start15 Apr 2024 (estimated)
- Primary completion15 Jul 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Collaborators
- Paris Brain Institute (ICM), Centre Hospitalier Régional d'Orléans
- Responsible party
- Sponsor
- Investigators
- Guillaume Turc, Principal investigator, GHU Psychiatrie et Neurosciences de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344221
- Sponsor's protocol ID
- 2023-A00954-41
- Acronym
- HapticS
- Status last verified
- Mar 2024
- First submitted
- 16 Feb 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-stroke Haptic Feedback Use Deficit: A Comparative and Reliability Study
- ClinicalTrials.gov ID
- NCT06344221
- Acronym / sponsor ID
- HapticS / 2023-A00954-41
- Conditions
- Stroke, Upper Extremity Paresis, Manual Dexterity, Sensory Integration Dysfunction, Vibration; Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Collaborators
- Paris Brain Institute (ICM), Centre Hospitalier Régional d'Orléans
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Young Healthy Controls | Active comparator | Device: Dextrain Manipulandum and haptic feedback deviceThe 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. |
| Healthy controls matched in age and sex with stroke patients | Active comparator | Device: Dextrain Manipulandum and haptic feedback deviceThe 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 | Experimental | Device: Dextrain Manipulandum and haptic feedback deviceThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- Contraindication to TMS (epilepsy, metal implants)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextrain Manipulandum and haptic feedback deviceAlso: Transcranial Magnetic StimulationAssessment of key components of manual dexterity in addition to vibrotactile stimulation on the fingers and wrist. | Device | Chronic stroke patients, Healthy controls matched in age and sex with stroke patients, Young Healthy Controls |
Primary outcome
Assessing haptic effect during a dexterity exercise with and without sensory feedback: finger independence
Time frame: 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.
9 secondary outcomes
Assessing haptic effect during another dexterity exercise with and without sensory feedback: the force control of the index
Time frame: 1 day
Assessing haptic effect during another dexterity exercise with and without sensory feedback: the rhythm capacity
Time frame: 1 day
Correlation between clinical assessment and haptic measure
Time frame: 1 day
Assessment of the feasibility of the haptic measures
Time frame: 1 day
Assessment of the benefits of the haptic measures
Time frame: 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
Time frame: 1 day
Assessment of the impact of age on the dexterity performances (Finger independence, force control of the index and rhythm capacity)
Time frame: 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)
Time frame: 1 day
Transcranial magnetic stimulation (TMS)
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabrina Lekcir contact
Guillaume Turc principal investigator
GHU Psychiatrie et Neurosciences de Paris
Questions about this trial
What is this clinical trial studying?
A study testing Dextrain Manipulandum and haptic feedback device in people with Stroke and Upper Extremity Paresis, run by Centre Hospitalier St Anne.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Påvel Lindberg (+33140789244, pavel.lindberg@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing haptic effect during a dexterity exercise with and without sensory feedback: finger independence (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.