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StrokeERASMNCT02664636

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

A study testing Physiotherapy, Occupational therapy and Functional near-infrared spectroscopy in people with Stroke, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Stroke
What is being tested?
Physiotherapy, Occupational therapy and Functional near-infrared spectroscopy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesFrance
Study dates
Feb 2016to 30 Aug 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • CHRU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi

    Le Grau-du-Roi, 30240

  • CHRU de Montpellier - Hôpital Lapeyronie

    Montpellier, 34295

Other trials in France

About this study

Official 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)

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.

Read the detailed description

The secondary objectives of this study are:

  1. 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
Stroke
Being tested
Physiotherapy, Occupational therapy, Functional near-infrared spectroscopy
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PhysiotherapyProcedure or surgery

    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 therapyProcedure or surgery

    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 spectroscopyProcedure or surgery

    Also called fNIRS

    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.

Study groups in NCT02664636
Study groupRoleWhat they receive
The study populationExperimentalThe 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
Receives: Procedure: Physiotherapy; Procedure: Occupational therapy; Procedure: Functional near-infrared spectroscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Day 0

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

    Measured: Day 15

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

    Measured: Day 30

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

    Measured: Day 45

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

    Measured: Day 60

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

    Measured: Day 0

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

    Measured: Day 15

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

    Measured: Day 30

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

    Measured: Day 45

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

    Measured: Day 60

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

    Measured: Day 0

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

    Measured: Day 15

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

    Measured: Day 30

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

    Measured: Day 45

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

    Measured: Day 60

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

    Measured: Day 0

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

    Measured: Day 15

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

    Measured: Day 30

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

    Measured: Day 45

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

    Measured: 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

    Voluntary force refers to the force applied during motricity tasks.

    Measured: Day 0

  22. 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.

    Measured: Day 15

  23. 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.

    Measured: Day 30

  24. 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.

    Measured: Day 45

  25. 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.

    Measured: Day 60

  26. 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.

    Measured: Day 0

  27. 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.

    Measured: Day 15

  28. 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.

    Measured: Day 30

  29. 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.

    Measured: Day 45

  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.

    Measured: Day 60

  31. Voluntary force: coefficient of variation

    Voluntary force refers to the force applied during motricity tasks.

    Measured: Day 0

  32. Voluntary force: coefficient of variation

    Voluntary force refers to the force applied during motricity tasks.

    Measured: Day 15

  33. Voluntary force: coefficient of variation

    Voluntary force refers to the force applied during motricity tasks.

    Measured: Day 30

  34. Voluntary force: coefficient of variation

    Voluntary force refers to the force applied during motricity tasks.

    Measured: Day 45

  35. Voluntary force: coefficient of variation

    Voluntary force refers to the force applied during motricity tasks.

    Measured: Day 60

  36. Fugl-Meyer motricity score

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

    Measured: Day 0

  37. Fugl-Meyer motricity score

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

    Measured: Day 15

  38. Fugl-Meyer motricity score

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

    Measured: Day 30

  39. Fugl-Meyer motricity score

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

    Measured: Day 45

  40. Fugl-Meyer motricity score

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

    Measured: Day 60

Secondary outcomes (6)

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

    Measured: Day 0

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

    Measured: Day 60

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

    Measured: Day 0

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

    Measured: Day 60

  5. The Barthell test for autonomy

    Measured: Day 0

  6. The Barthell test for autonomy

    Measured: Day 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completion30 Aug 2016
  4. Study completion30 Aug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02664636
Sponsor's protocol ID
LOCAL/2015/JF-02
Other IDs
2015-A01624-45
Acronym
ERASM
Status last verified
Aug 2016
First submitted
19 Jan 2016
Last updated
19 Nov 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Delorme M, Vergotte G, Perrey S, Froger J, Laffont I. Time course of sensorimotor cortex reorganization during upper extremity task accompanying motor recovery early after stroke: An fNIRS study. Restor Neurol Neurosci. 2019;37(3):207-218. doi: 10.3233/RNN-180877.

    PubMed 31227675

Questions about this trial

What is this clinical trial studying?

A study testing Physiotherapy, Occupational therapy and Functional near-infrared spectroscopy in people with Stroke, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation (time frame: Day 0). The study lists 40 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02664636, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.

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