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

NCT07340736 | Not Yet Recruiting

• 1 other identifier: 2025-A00115-44
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

stroke; haptic; vibration; sensorimotor impairment; manual dexterity; prediction of recovery; MRI

Outcome Measures

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.

  3 months post enrollment

Secondary Outcomes (6)

• 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.

  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.

  3 and 6 months post enrollment

• Difference in functional and structural connectivity between subgroups with vs without haptic effect 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

  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.

  6 months post enrollement

Study Arms (2)

Stroke patients in the early subacute phase

EXPERIMENTAL

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; Other: Brain MRI

Healthy controls matched in age, sex and laterality with stroke patients

ACTIVE COMPARATOR

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; Other: Brain MRI

Interventions

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.

Healthy controls matched in age, sex and laterality with stroke patients; Stroke patients in the early subacute phase

Brain MRI OTHER

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

Healthy controls matched in age, sex and laterality with stroke patients; Stroke patients in the early subacute phase

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (1)

GHU Psychiatrie et Neurosciences

Paris, 75014, France

Location

MeSH Terms

Conditions

Stroke; Paresis

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

Central Study Contacts

Pavel Lindberg

CONTACT

+33140789244; pavel.lindberg@inserm.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: January 5, 2026
• First Posted: January 14, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)