Cortical Reorganization Models for Motor Areas and Inter-hemispheric Equilibrium Post-stroke: a Pilot Study

Study Overview
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Brief Summary
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The main objective is to develop models for the cortical reorganization of motor areas and inter-hemispheric equilibrium in the early phase of post stroke recovery evaluated by the fNIRS technique from day 0 to day 60 (day 0 being the day of inclusion in the study) and to correlate the latter with the early phases of motor recovery over the same period, as measured by the test Fugl-Meyer.

Detailed Description
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The secondary objectives of this study are: A. To evaluate changes in functional outcomes (Box and Blocks Test and NineHolePeg Test from Day 0 to Day 60. B- To evaluate changes in autonomy (Barthel Index) from Day 0 to Day 60.

Official Title
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Pilot Study on the Development of Cortical Reorganization Models for Motor Areas and Inter-hemispheric Equilibrium in the Post-stroke Early Recovery Phase Evaluated by Functional Near-infrared Spectroscopy (fNIRS)

Conditions
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Stroke

Intervention / Treatment
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* Procedure: Physiotherapy
* Procedure: Occupational therapy
* Procedure: Functional near-infrared spectroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient has had a first ischemic or haemorrhagic supra-tentorial stroke within the 2 to 4 weeks preceding inclusion Exclusion Criteria: The patient is participating in another study The patient is in an exclusion period determined by a previous study The patient is under judicial protection, under tutorship or curatorship The patient refuses to sign the consent It is impossible to correctly inform the patient The patient is pregnant, parturient, or breastfeeding The patient presents with a severe cognitive disorder The patient has severe aphasia with a Boston Diagnostic Aphasia Examination (BDAE) scale score strictly less than 2 The patient has heminegligence with a bells test > 6 on the left. The patient presents with limited amplitude in the paretic upper limb (shoulder abduction <60°, elbow flexion > 30° or dorsal wrist flexion <20°). Imbalanced/uncontrolled epilepsy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The study population<br>The study population consists of patients 20 and 75 years of age who have had a supra-tentorial ischemic or hemorrhagic stroke. The study covers consulting or hospitalized patients at the neurological rehabilitation service (NHS) of Grau du Roi Medical Center, part of the Nîmes University Hospital. Most patients originate from a 2-4 week stay in the neurological acute care, cardiac or polyvalent departments of the University Hospitals of Montpellier or Nîmes. Intervention: Physiotherapy Intervention: Occupational therapy Intervention: Functional near-infrared spectroscopy | Procedure: Physiotherapy<br>* Physiotherapy regimen (days 0 to 60): orthopedic maintenance, work on trunk balance, sensorimotor techniques for restoration of motor skills, exercises for standing balance and walking. Sessions last 30 to 60 minutes depending on the fatigue of the subject and the level of recovery. They occur as daily sessions during the first two weeks and then two sessions / day. This is part of routine care.<br>Procedure: Occupational therapy<br>* Occupational Therapy (days 0 to 60): Orthopaedic maintenance, exercises for sitting and standing balance, sensorimotor techniques for the restoration of motor skills, grip exercises. Sessions last 30 to 60 minutes depending on the fatigue of the subject and the level of recovery. 1 session is performed per day. This is part of routine care.<br>Procedure: Functional near-infrared spectroscopy<br>* During the therapy protocol, cortical activation measures using the fNIRS method will be conducted every 15 days (at Day0, Day 15, Day 30, Day 45 and Day 60 for 5 sessions in total) at the technical platform of the Grau du Roi physical therapy centre, during the completion of a standardized motor task (maintaining a level of force) using the healthy upper limb and the paretic upper limb.<br>* Other names: fNIRS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation |  | Day 0 | 
| Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation |  | Day 15 | 
| Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation |  | Day 30 | 
| Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation |  | Day 45 | 
| Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation |  | Day 60 | 
| Near-infrared spectroscopy signal analysis: the amplitude peak |  | Day 0 | 
| Near-infrared spectroscopy signal analysis: the amplitude peak |  | Day 15 | 
| Near-infrared spectroscopy signal analysis: the amplitude peak |  | Day 30 | 
| Near-infrared spectroscopy signal analysis: the amplitude peak |  | Day 45 | 
| Near-infrared spectroscopy signal analysis: the amplitude peak |  | Day 60 | 
| Near-infrared spectroscopy signal analysis: the time required to reach the peak |  | Day 0 | 
| Near-infrared spectroscopy signal analysis: the time required to reach the peak |  | Day 15 | 
| Near-infrared spectroscopy signal analysis: the time required to reach the peak |  | Day 30 | 
| Near-infrared spectroscopy signal analysis: the time required to reach the peak |  | Day 45 | 
| Near-infrared spectroscopy signal analysis: the time required to reach the peak |  | Day 60 | 
| Near-infrared spectroscopy signal analysis: the laterality index |  | Day 0 | 
| Near-infrared spectroscopy signal analysis: the laterality index |  | Day 15 | 
| Near-infrared spectroscopy signal analysis: the laterality index |  | Day 30 | 
| Near-infrared spectroscopy signal analysis: the laterality index |  | Day 45 | 
| Near-infrared spectroscopy signal analysis: the laterality index |  | Day 60 | 
| Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength | Voluntary force refers to the force applied during motricity tasks. | Day 0 | 
| Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength | Voluntary force refers to the force applied during motricity tasks. | Day 15 | 
| Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength | Voluntary force refers to the force applied during motricity tasks. | Day 30 | 
| Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength | Voluntary force refers to the force applied during motricity tasks. | Day 45 | 
| Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength | Voluntary force refers to the force applied during motricity tasks. | Day 60 | 
| Voluntary force: average | Voluntary force refers to the force applied during motricity tasks. Average refers to the sum of measures weighted by the number of measures. | Day 0 | 
| Voluntary force: average | Voluntary force refers to the force applied during motricity tasks. Average refers to the sum of measures weighted by the number of measures. | Day 15 | 
| Voluntary force: average | Voluntary force refers to the force applied during motricity tasks. Average refers to the sum of measures weighted by the number of measures. | Day 30 | 
| Voluntary force: average | Voluntary force refers to the force applied during motricity tasks. Average refers to the sum of measures weighted by the number of measures. | Day 45 | 
| Voluntary force: average | Voluntary force refers to the force applied during motricity tasks. Average refers to the sum of measures weighted by the number of measures. | Day 60 | 
| Voluntary force: coefficient of variation | Voluntary force refers to the force applied during motricity tasks. | Day 0 | 
| Voluntary force: coefficient of variation | Voluntary force refers to the force applied during motricity tasks. | Day 15 | 
| Voluntary force: coefficient of variation | Voluntary force refers to the force applied during motricity tasks. | Day 30 | 
| Voluntary force: coefficient of variation | Voluntary force refers to the force applied during motricity tasks. | Day 45 | 
| Voluntary force: coefficient of variation | Voluntary force refers to the force applied during motricity tasks. | Day 60 | 
| Fugl-Meyer motricity score | The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills. | Day 0 | 
| Fugl-Meyer motricity score | The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills. | Day 15 | 
| Fugl-Meyer motricity score | The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills. | Day 30 | 
| Fugl-Meyer motricity score | The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills. | Day 45 | 
| Fugl-Meyer motricity score | The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills. | Day 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Box and Block test: The score is the number of blocks transferred in one minute. |  | Day 0 | 
| The Box and Block test: The score is the number of blocks transferred in one minute. |  | Day 60 | 
| The Nine Hole Peg Test: The score is the total time to complete the task. |  | Day 0 | 
| The Nine Hole Peg Test: The score is the total time to complete the task. |  | Day 60 | 
| The Barthell test for autonomy |  | Day 0 | 
| The Barthell test for autonomy |  | Day 60 |