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NCT Number: NCT07340736

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Manual Dexterity Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Sensory Integration Dysfunction Signs and Symptoms Upper Extremity Paresis Vascular Diseases Vibration

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GHU Psychiatrie et Neurosciences

Paris, 75014, France

Location contact

Sabrina Lekcir

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Haptic stimulation device

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.

Brain MRI

Other

Subjects and patients will undergo anatomical, resting-state functional, and diffusion brain MRI sequences.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. 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. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Pavel Lindberg

CONTACT

[email protected]

+33140789244

Sponsors and collaborators

Lead sponsor

Centre Hospitalier St Anne

Other

Registry information

Acronym: HapticS 2

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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