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

Completed

Phase N/A Results N/A

Trial Description

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

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.

Conditions

Interventions

  • Occupational therapy Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: The study population
    Description: 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
  • Physiotherapy Behavioral
    Other Names: Exercise
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: The study population
    Description: 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
  • Functional near-infrared spectroscopy Procedure
    Other Names: fNIRS
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: The study population
    Description: 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

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation Day 0 No
Primary Near-infrared spectroscopy signal analysis: the amplitude peak Day 0 No
Primary Near-infrared spectroscopy signal analysis: the time required to reach the peak Day 0 No
Primary Near-infrared spectroscopy signal analysis: the laterality index Day 0 No
Primary Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength Day 0 No
Primary Voluntary force: average Day 0 No
Primary Voluntary force: coefficient of variation Day 0 No
Primary Fugl-Meyer motricity score Day 0 No
Secondary The Box and Block test: The score is the number of blocks transferred in one minute. Day 0 No
Secondary The Nine Hole Peg Test: The score is the total time to complete the task. Day 0 No
Secondary The Barthell test for autonomy Day 0 No

Sponsors