Sensory Mechanisms of Manual Dexterity Recovery After Stroke: a Prospective Cohort Study of Prediction and Cerebral Correlates (HapticS 2)

January 5, 2026 updated by: Centre Hospitalier St Anne
In the proposed research, we will assess motor and sensory functions of the hand using clinical tests and a tool designed to measure manual dexterity combined with vibrotactile stimulation. We will also evaluate the integrity of brain structure and function using MRI.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this study, 90 post-stroke patients will be followed over three visits at 3 weeks, 3 months, and 6 months after stroke. Manual dexterity will be assessed using the Dextrain Manipulandum, both with and without the addition of finger vibrations. These vibrations will be delivered using vibratory rings, a tool that has been developed and is currently being validated in healthy participants and in patients with chronic post-stroke conditions. These measurements will allow us to quantify haptic facilitation, that is the impact of adding finger vibrations on hand motor function.

During each of the three visits, we will also administer validated sensory, motor, and cognitive clinical assessments, as well as anatomical, resting-state functional, and diffusion MRI sequences to investigate brain structure and function in relation to this haptic facilitation. These longitudinal measurements will enable the development of biomarkers of motor recovery of manual dexterity after stroke, with the primary objective of improving the prediction of dexterity recovery using a regression model.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • First symptomatic stroke, ischaemic or haemorrhagic in the early subacute phase (up to 3 weeks post-stroke)
  • Upper limb paresis (≤4/5 MRC Scale)
  • Ability to grasp, lift and put down 1 block (from the BBT test)
  • Be affiliated to a social security

Exclusion Criteria:

  • Presence of another neurological or musculoskeletal condition affecting upper limb movement
  • Severe cognitive impairment and/or aphasia with inability to understand and carry out instructions
  • Contraindications to MRI (claustrophobia, presence of cochlear implants and/or pacemakers)
  • Persons subject to legal protection measures
  • Persons subject to judicial protection measures
  • Pregnancy
  • Life-threatening conditions or conditions requiring follow-up at 6 months
  • Epilepsy
  • Known hypersensitivity or allergy to silicone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Stroke patients in the early subacute phase
Patients will be followed for 6 months over three visits. They will undergo validated sensory, motor, and cognitive clinical assessments, as well as MRI scans and manual dexterity tests performed with and without the addition of vibratory stimulation to the fingers, using a tool previously developed as part of this project.
Device: Haptic stimulation device
Both patients and healthy participants will perform manual dexterity tasks using the Dextrain Manipulandum. In addition, they will receive finger vibrations delivered via rings that we have previously developed. These vibrations will have a frequency of 150 Hz and will be delivered for a duration of 150 ms.
Other: Brain MRI
Subjects and patients will undergo anatomical, resting-state functional, and diffusion brain MRI sequences.
Active Comparator: Healthy controls matched in age, sex and laterality with stroke patients
Healthy control participants will be assessed during a single visit. They will undergo motor, sensory, and cognitive clinical assessments, as well as manual dexterity tasks performed with and without the addition of finger vibrations using a previously developed tool. They will also undergo anatomical, resting-state functional, and diffusion brain MRI sequences. Each healthy participant will be matched to a patient in terms of age, sex, and handedness of the affected limb. For example, if we include a 60-year-old male post-stroke patient who is right-handed and has a right upper-limb impairment, we will include a healthy male participant aged 60 ± 5 years who is also right-handed.
Device: Haptic stimulation device
Both patients and healthy participants will perform manual dexterity tasks using the Dextrain Manipulandum. In addition, they will receive finger vibrations delivered via rings that we have previously developed. These vibrations will have a frequency of 150 Hz and will be delivered for a duration of 150 ms.
Other: Brain MRI
Subjects and patients will undergo anatomical, resting-state functional, and diffusion brain MRI sequences.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gain in the prediction of manual dexterity recovery
Time Frame: 3 months post enrollment
The primary outcome measure is a 10% improvement in the prediction of the Box and Block Test (BBT) score at 3 and 6 months post-stroke achieved by adding the haptic effect to a multivariate model.
3 months post enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in the prediction of the Box and Block Test (BBT) score when taking into account the haptic effect during an index finger force control task.
Time Frame: 3 and 6 months post enrollment
Determine whether the haptic effect calculated during an index finger force control exercise (using the dextrain manipulandum) measured in the acute phase after stroke can improve the prediction of manual dexterity recovery (Box and Blocks Test, BBT) at 3 months and 6 months after stroke.
3 and 6 months post enrollment
Predicting recovery in various clinical tests of motor and sensory function and activity limitations at 3 months and 6 months post-stroke.
Time Frame: 3 and 6 months post enrollment
Determine whether the haptic effect VS absence of haptic effect improves the prediction of recovery from motor impairment (Fugl Mayer Assessment for Upper Extremity FMA-UE, Purdue Pegboard Test), sensitivity (monofilaments and Nottingham Sensory Assessment), and activity limitations (Stroke Impact Scale) of the upper limb from 3 weeks to 3 and 6 months post-stroke.
3 and 6 months post enrollment
Difference in functional and structural connectivity between subgroups with vs without haptic effect at 3 and 6 months
Time Frame: 3 and 6 months post enrollement
Investigate whether connectivity of fronto-parietal networks at 3 weeks post-stroke predicts recovery of haptic effect and dexterity at 3 and 6 months.
3 and 6 months post enrollement
Changes in the structural and functional connectivity of fronto-parietal networks between 3 weeks and 6 months post-stroke
Time Frame: 3 and 6 months post stroke
A difference in the change in connectivity between subgroups with versus without haptic effect at 6 months will be investigated.
3 and 6 months post stroke
Difference in brain connectivity between brain images of healthy subjects and patients 3 weeks post-stroke and healthy subjects and patients 6 months post-stroke.
Time Frame: 6 months post enrollement
Compare brain connectivity between the group of healthy subjects and the group of patients at 3 weeks and 6 months post-stroke.
6 months post enrollement
Correlation between the location of the lesion at 3 weeks and the haptic effect and the results of clinical tests
Time Frame: 3 and 6 months post stroke
These correlations will be done using Voxel Based Lesion Symptoms Mapping technique (VLSM)
3 and 6 months post stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier St Anne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-A00115-44

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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