Light Constraint Induced Therapy Experiment (LICITE)
Effects of a Modified Constraint Induced Therapy Intervention in Stroke Patients: A Multicenter, Randomized Controlled Trial.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Constraint-Induced Movement therapy or CI therapy is a rehabilitation method, that has been shown in controlled studies to produce improvements of upper limb motor function in stroke patients. However, in the original method, 6 hours of daily training are requested, which is often impossible to apply in the majority of rehabilitation unit.
The aim of this trial is to compare the effect of a modified constraint induced therapy (90 minutes of motor training with a physical or occupational therapist and 270 minutes of self-rehabilitation) to the treatment described originally by Taub et al. (360 minutes of motor training with a physical or occupational therapist).
Patients randomly received one of the two treatment and be evaluated pre- post- and 3 months after the intervention ended. The treatment will last two weeks, five days per week. The evaluations will include clinical measure of motor function and functional MRI of the brain. The brain activity will be measure just before and after the intervention with a manual motor task in order to asses brain plasticity.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Paris Cedex 18
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Paris, Paris Cedex 18, Frankrig, 75877
- Service de Médecine Physique et de Réadaptation - Hôpital BICHAT
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
INCLUSION CRITERIA:
- Age > 18 years
- First ischemic or hemorrhagic stroke between 2 and 12 months
- at least 10°of active wrist extension and at least 10° of thumb abduction/ extension, and at least 10° of extension in at least 2 additional digits.
- adequate balance while wearing the restraint
EXCLUSION CRITERIA:
- Major cognitive impairment
- Prior stroke
- Excessive fatigability
- Severe aphasia
- MAL score ≥ 2,5
- Specific exclusion criteria for fMRI ancillary study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Standard terapi
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360 minutes of motor training with a physical or occupational therapist, 5 days/week/2 weeks
Andre navne:
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Aktiv komparator: Modified Therapy
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90 minutes of motor training with a physical or occupational therapist and 270 minutes of self-rehabilitation, 5 days/week/2 weeks.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Motor activity log scale
Tidsramme: 10 days before inclusion, 10 days and 3 months after treatment achievement
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10 days before inclusion, 10 days and 3 months after treatment achievement
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Wolf Motor Function test Stroke impact scale Functional MRI HAD scale
Tidsramme: 10 days before inclusion, 10 days and 3 months after treatment achievement except for fMRI (no evaluation at 3 month)
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10 days before inclusion, 10 days and 3 months after treatment achievement except for fMRI (no evaluation at 3 month)
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Olivier SIMON, MD, PhD, Assistance Publique - Hôpitaux de Paris
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- 1- Constraint induced therapy
- 2- Stroke
- 3- Upper limb
- 4- Rehabilitation
- 5- Motor training
- 1- First time clinical ischemic or hemorrhagic stroke
- 2- At least 10° of active wrist extension
- 3- At least 10° of thumb abduction/ extension
- 4- At least 10° of extension in at least 2 additional digits
- 3- Adequate balance while wearing the restraint.
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P070161
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Kliniske forsøg med Light constraint induced therapy
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US Department of Veterans AffairsAfsluttet
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University of BirminghamAfsluttet
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Region Jönköping CountyFuturum - Academy for health and careAfsluttetSlag | Neurologiske sygdomme eller tilstandeSverige
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Riphah International UniversityAfsluttetHemiplegisk cerebral paresePakistan
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Samsung Medical CenterUkendtHemiplegisk cerebral parese med spasticitet (diagnose)Korea, Republikken
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University of Alabama at BirminghamAfsluttetSlag | Parese i øvre ekstremitet | CVA (Cerebrovaskulær Accident)Forenede Stater
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Batterjee Medical CollegeAfsluttetHemiplegisk cerebral parese | SpejlhænderSaudi Arabien
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Texas Scottish Rite Hospital for ChildrenTexas Woman's UniversityAfsluttet
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Montiha AzeemRekruttering