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

25. august 2016 oppdatert av: Centre Hospitalier Universitaire de Nīmes

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

10

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Frankrike
      • Le Grau du Roi, Frankrike, 30240
        • CHRU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
      • Montpellier, Frankrike, 34295
        • CHRU de Montpellier - Hôpital Lapeyronie

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: The study population

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
Fremgangsmåte: Physiotherapy

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.

Fremgangsmåte: Occupational therapy

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.

Fremgangsmåte: Functional near-infrared spectroscopy
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.
Andre navn:
  • fNIRS

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tidsramme
The Box and Block test: The score is the number of blocks transferred in one minute.
Tidsramme: Day 0
Day 0
The Box and Block test: The score is the number of blocks transferred in one minute.
Tidsramme: Day 60
Day 60
The Nine Hole Peg Test: The score is the total time to complete the task.
Tidsramme: Day 0
Day 0
The Nine Hole Peg Test: The score is the total time to complete the task.
Tidsramme: Day 60
Day 60
The Barthell test for autonomy
Tidsramme: Day 0
Day 0
The Barthell test for autonomy
Tidsramme: Day 60
Day 60

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Etterforskere

  • Hovedetterforsker: Jérôme Froger, MD, Centre Hospitalier Universitaire De Nimes

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2016

Primær fullføring (Faktiske)

1. august 2016

Studiet fullført (Faktiske)

1. august 2016

Datoer for studieregistrering

Først innsendt

19. januar 2016

Først innsendt som oppfylte QC-kriteriene

26. januar 2016

Først lagt ut (Anslag)

27. januar 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

26. august 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. august 2016

Sist bekreftet

1. august 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • LOCAL/2015/JF-02
  • 2015-A01624-45 (Annen identifikator: RCB number)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

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