Light Constraint Induced Therapy Experiment (LICITE)
Effects of a Modified Constraint Induced Therapy Intervention in Stroke Patients: A Multicenter, Randomized Controlled Trial.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
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Paris Cedex 18
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Paris, Paris Cedex 18, Frankrike, 75877
- Service de Médecine Physique et de Réadaptation - Hôpital BICHAT
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Standard terapi
|
360 minutes of motor training with a physical or occupational therapist, 5 days/week/2 weeks
Andre navn:
|
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Aktiv komparator: Modified Therapy
|
90 minutes of motor training with a physical or occupational therapist and 270 minutes of self-rehabilitation, 5 days/week/2 weeks.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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 |
|---|---|
|
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)
|
10 days before inclusion, 10 days and 3 months after treatment achievement except for fMRI (no evaluation at 3 month)
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Olivier SIMON, MD, PhD, Assistance Publique - Hôpitaux de Paris
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
- 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.
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P070161
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