Cortical Reorganization Models for Motor Areas and Inter-hemispheric Equilibrium Post-stroke: a Pilot Study (ERASM)
25. srpna 2016 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
10
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Le Grau du Roi, Francie, 30240
- CHRU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
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Montpellier, Francie, 34295
- CHRU de Montpellier - Hôpital Lapeyronie
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
20 let až 75 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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 |
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 (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.
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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation
Časové okno: Day 0
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Day 0
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Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation
Časové okno: Day 15
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Day 15
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Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation
Časové okno: Day 30
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Day 30
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Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation
Časové okno: Day 45
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Day 45
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Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation
Časové okno: Day 60
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Day 60
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Near-infrared spectroscopy signal analysis: the amplitude peak
Časové okno: Day 0
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Day 0
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Near-infrared spectroscopy signal analysis: the amplitude peak
Časové okno: Day 15
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Day 15
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Near-infrared spectroscopy signal analysis: the amplitude peak
Časové okno: Day 30
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Day 30
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Near-infrared spectroscopy signal analysis: the amplitude peak
Časové okno: Day 45
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Day 45
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Near-infrared spectroscopy signal analysis: the amplitude peak
Časové okno: Day 60
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Day 60
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Near-infrared spectroscopy signal analysis: the time required to reach the peak
Časové okno: Day 0
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Day 0
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Near-infrared spectroscopy signal analysis: the time required to reach the peak
Časové okno: Day 15
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Day 15
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Near-infrared spectroscopy signal analysis: the time required to reach the peak
Časové okno: Day 30
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Day 30
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Near-infrared spectroscopy signal analysis: the time required to reach the peak
Časové okno: Day 45
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Day 45
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Near-infrared spectroscopy signal analysis: the time required to reach the peak
Časové okno: Day 60
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Day 60
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Near-infrared spectroscopy signal analysis: the laterality index
Časové okno: Day 0
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Day 0
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Near-infrared spectroscopy signal analysis: the laterality index
Časové okno: Day 15
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Day 15
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Near-infrared spectroscopy signal analysis: the laterality index
Časové okno: Day 30
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Day 30
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Near-infrared spectroscopy signal analysis: the laterality index
Časové okno: Day 45
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Day 45
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Near-infrared spectroscopy signal analysis: the laterality index
Časové okno: Day 60
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Day 60
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Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength
Časové okno: Day 0
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Voluntary force refers to the force applied during motricity tasks.
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Day 0
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Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength
Časové okno: Day 15
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Voluntary force refers to the force applied during motricity tasks.
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Day 15
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Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength
Časové okno: Day 30
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Voluntary force refers to the force applied during motricity tasks.
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Day 30
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Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength
Časové okno: Day 45
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Voluntary force refers to the force applied during motricity tasks.
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Day 45
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Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength
Časové okno: Day 60
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Voluntary force refers to the force applied during motricity tasks.
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Day 60
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Voluntary force: average
Časové okno: Day 0
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Voluntary force refers to the force applied during motricity tasks.
"Average" refers to the sum of measures weighted by the number of measures.
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Day 0
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Voluntary force: average
Časové okno: Day 15
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Voluntary force refers to the force applied during motricity tasks.
"Average" refers to the sum of measures weighted by the number of measures.
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Day 15
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Voluntary force: average
Časové okno: Day 30
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Voluntary force refers to the force applied during motricity tasks.
"Average" refers to the sum of measures weighted by the number of measures.
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Day 30
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Voluntary force: average
Časové okno: Day 45
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Voluntary force refers to the force applied during motricity tasks.
"Average" refers to the sum of measures weighted by the number of measures.
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Day 45
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Voluntary force: average
Časové okno: Day 60
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Voluntary force refers to the force applied during motricity tasks.
"Average" refers to the sum of measures weighted by the number of measures.
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Day 60
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Voluntary force: coefficient of variation
Časové okno: Day 0
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Voluntary force refers to the force applied during motricity tasks.
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Day 0
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Voluntary force: coefficient of variation
Časové okno: Day 15
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Voluntary force refers to the force applied during motricity tasks.
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Day 15
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Voluntary force: coefficient of variation
Časové okno: Day 30
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Voluntary force refers to the force applied during motricity tasks.
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Day 30
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Voluntary force: coefficient of variation
Časové okno: Day 45
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Voluntary force refers to the force applied during motricity tasks.
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Day 45
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Voluntary force: coefficient of variation
Časové okno: Day 60
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Voluntary force refers to the force applied during motricity tasks.
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Day 60
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Fugl-Meyer motricity score
Časové okno: Day 0
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The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.
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Day 0
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Fugl-Meyer motricity score
Časové okno: Day 15
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The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.
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Day 15
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Fugl-Meyer motricity score
Časové okno: Day 30
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The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.
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Day 30
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Fugl-Meyer motricity score
Časové okno: Day 45
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The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.
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Day 45
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Fugl-Meyer motricity score
Časové okno: Day 60
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The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.
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Day 60
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
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The Box and Block test: The score is the number of blocks transferred in one minute.
Časové okno: Day 0
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Day 0
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The Box and Block test: The score is the number of blocks transferred in one minute.
Časové okno: Day 60
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Day 60
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The Nine Hole Peg Test: The score is the total time to complete the task.
Časové okno: Day 0
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Day 0
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The Nine Hole Peg Test: The score is the total time to complete the task.
Časové okno: Day 60
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Day 60
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The Barthell test for autonomy
Časové okno: Day 0
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Day 0
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The Barthell test for autonomy
Časové okno: Day 60
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Day 60
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Jérôme Froger, MD, Centre Hospitalier Universitaire De Nimes
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. února 2016
Primární dokončení (Aktuální)
1. srpna 2016
Dokončení studie (Aktuální)
1. srpna 2016
Termíny zápisu do studia
První předloženo
19. ledna 2016
První předloženo, které splnilo kritéria kontroly kvality
26. ledna 2016
První zveřejněno (Odhad)
27. ledna 2016
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
26. srpna 2016
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
25. srpna 2016
Naposledy ověřeno
1. srpna 2016
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- LOCAL/2015/JF-02
- 2015-A01624-45 (Jiný identifikátor: RCB number)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .