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Completed

NCT Number: NCT02664636

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi, Le Grau-du-Roi, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

physiotherapy

Procedure

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.

Occupational therapy

Procedure

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.

Functional near-infrared spectroscopy

Procedure

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.

Other names: fNIRS

Primary outcomes

  1. Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation

    Time frame: Day 0

  2. Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation

    Time frame: Day 15

  3. Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation

    Time frame: Day 30

  4. Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation

    Time frame: Day 45

  5. Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation

    Time frame: Day 60

  6. Near-infrared spectroscopy signal analysis: the amplitude peak

    Time frame: Day 0

  7. Near-infrared spectroscopy signal analysis: the amplitude peak

    Time frame: Day 15

  8. Near-infrared spectroscopy signal analysis: the amplitude peak

    Time frame: Day 30

  9. Near-infrared spectroscopy signal analysis: the amplitude peak

    Time frame: Day 45

  10. Near-infrared spectroscopy signal analysis: the amplitude peak

    Time frame: Day 60

  11. Near-infrared spectroscopy signal analysis: the time required to reach the peak

    Time frame: Day 0

  12. Near-infrared spectroscopy signal analysis: the time required to reach the peak

    Time frame: Day 15

  13. Near-infrared spectroscopy signal analysis: the time required to reach the peak

    Time frame: Day 30

  14. Near-infrared spectroscopy signal analysis: the time required to reach the peak

    Time frame: Day 45

  15. Near-infrared spectroscopy signal analysis: the time required to reach the peak

    Time frame: Day 60

  16. Near-infrared spectroscopy signal analysis: the laterality index

    Time frame: Day 0

  17. Near-infrared spectroscopy signal analysis: the laterality index

    Time frame: Day 15

  18. Near-infrared spectroscopy signal analysis: the laterality index

    Time frame: Day 30

  19. Near-infrared spectroscopy signal analysis: the laterality index

    Time frame: Day 45

  20. Near-infrared spectroscopy signal analysis: the laterality index

    Time frame: Day 60

  21. Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength

    Time frame: Day 0

    Voluntary force refers to the force applied during motricity tasks.

  22. Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength

    Time frame: Day 15

    Voluntary force refers to the force applied during motricity tasks.

  23. Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength

    Time frame: Day 30

    Voluntary force refers to the force applied during motricity tasks.

  24. Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength

    Time frame: Day 45

    Voluntary force refers to the force applied during motricity tasks.

  25. Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength

    Time frame: Day 60

    Voluntary force refers to the force applied during motricity tasks.

  26. Voluntary force: average

    Time frame: Day 0

    Voluntary force refers to the force applied during motricity tasks. "Average" refers to the sum of measures weighted by the number of measures.

  27. Voluntary force: average

    Time frame: Day 15

    Voluntary force refers to the force applied during motricity tasks. "Average" refers to the sum of measures weighted by the number of measures.

  28. Voluntary force: average

    Time frame: Day 30

    Voluntary force refers to the force applied during motricity tasks. "Average" refers to the sum of measures weighted by the number of measures.

  29. Voluntary force: average

    Time frame: Day 45

    Voluntary force refers to the force applied during motricity tasks. "Average" refers to the sum of measures weighted by the number of measures.

  30. Voluntary force: average

    Time frame: Day 60

    Voluntary force refers to the force applied during motricity tasks. "Average" refers to the sum of measures weighted by the number of measures.

  31. Voluntary force: coefficient of variation

    Time frame: Day 0

    Voluntary force refers to the force applied during motricity tasks.

  32. Voluntary force: coefficient of variation

    Time frame: Day 15

    Voluntary force refers to the force applied during motricity tasks.

  33. Voluntary force: coefficient of variation

    Time frame: Day 30

    Voluntary force refers to the force applied during motricity tasks.

  34. Voluntary force: coefficient of variation

    Time frame: Day 45

    Voluntary force refers to the force applied during motricity tasks.

  35. Voluntary force: coefficient of variation

    Time frame: Day 60

    Voluntary force refers to the force applied during motricity tasks.

  36. Fugl-Meyer motricity score

    Time frame: Day 0

    The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.

  37. Fugl-Meyer motricity score

    Time frame: Day 15

    The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.

  38. Fugl-Meyer motricity score

    Time frame: Day 30

    The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.

  39. Fugl-Meyer motricity score

    Time frame: Day 45

    The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.

  40. Fugl-Meyer motricity score

    Time frame: Day 60

    The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.

Secondary outcomes

  1. The Box and Block test: The score is the number of blocks transferred in one minute.

    Time frame: Day 0

  2. The Box and Block test: The score is the number of blocks transferred in one minute.

    Time frame: Day 60

  3. The Nine Hole Peg Test: The score is the total time to complete the task.

    Time frame: Day 0

  4. The Nine Hole Peg Test: The score is the total time to complete the task.

    Time frame: Day 60

  5. The Barthell test for autonomy

    Time frame: Day 0

  6. The Barthell test for autonomy

    Time frame: Day 60

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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)

Acronym: ERASM

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 27, 2016
Registry last updated
Nov 19, 2025

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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