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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorCentre Hospitalier St Anne

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Stroke patients in the early subacute phaseExperimental treatment 2 interventions
Group B: Healthy controls matched in age, sex and laterality with stroke patientsActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Gain in the prediction of manual dexterity recovery

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.

Time frame
3 months post enrollment

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.

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.

Time frame
3 and 6 months post enrollment
2

Predicting recovery in various clinical tests of motor and sensory function and activity limitations at 3 months and 6 months post-stroke.

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.

Time frame
3 and 6 months post enrollment
3

Difference in functional and structural connectivity between subgroups with vs without haptic effect at 3 and 6 months

Investigate whether connectivity of fronto-parietal networks at 3 weeks post-stroke predicts recovery of haptic effect and dexterity at 3 and 6 months.

Time frame
3 and 6 months post enrollement
4

Changes in the structural and functional connectivity of fronto-parietal networks between 3 weeks 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.

Time frame
3 and 6 months post stroke

Other outcomes

Sponsors and contacts

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