Effects of Home-based Neurostimulation Associated With Motor Training in Chronic Stroke Patients
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Design: Double-blind, randomized, controlled clinical trial. Setting: Home-based rehabilitation. Subjects: Patients in the chronic phase (> 6 months) after stroke. Interventions: Patients will be randomized to an active and a control group. In both groups, treatments will be performed at home, daily, over four weeks. Patients in the active group will be instructed to use a device that provides somatosensory stimulation in the form of electrical stimulation of the median nerve for two hours. Patients in the control group will also be instructed to use the device for two hours, and sham stimulation will be administered. In both groups, patients will be instructed to train activities with the paretic hand immediately after nerve stimulation.
Main measures: The primary outcome will be improvement in performance of the paretic hand evaluated by the Jebsen-Taylor test at end of treatment and four months after end of treatment, compared to baseline. Secondary outcomes were: 1) Compliance with the interventions, assessed through a daily written log, and oral reports of the patients; 2) safety profile of the interventions.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
SP
-
São Paulo, SP, Brasil, 55
- University of São Paulo/General Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- age 18-80 years;
- single ischemic or hemorrhagic stroke in a cerebral hemisphere, documented by computed tomography (CT) or magnetic resonance imaging (MRI);
- stroke onset at least six months before;
- hand paresis with preserved ability to perform all tasks of the Jebsen-Taylor Test (JTT).
Exclusion Criteria:
- previous strokes;
- epilepsy and other neurological conditions;
- proprioceptive or tactile anesthesia;
- shoulder or hand pain;
- severe joint deformity;
- severe chronic disease;
- inability to give provide informed consent due to severe aphasia or cognitive impairment;
- left handedness before the stroke.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Somatosensory stimulation
Active group
|
Electrical median nerve stimulation
Andre navn:
|
|
Placebo komparator: Control group
Placebo stimulation
|
Placebo stimulation
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
the improvement in upper extremity performance assessed using Jebsen-Taylor test
Tidsramme: Treatment lasted four weeks. Measures were performed before the treatment, immediately after the treatment and four months after the end of the treatment
|
Treatment lasted four weeks. Measures were performed before the treatment, immediately after the treatment and four months after the end of the treatment
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Compliance with the interventions, assessed through a daily written log, and oral reports of the patients
Tidsramme: immediately after the treatment
|
immediately after the treatment
|
|
Adverse events
Tidsramme: at end of treatment
|
at end of treatment
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Adriana Conforto, MD PhD, Hospital das Clínicas/FMUSP
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1309-06
- 477916/06-6 (Annet stipend/finansieringsnummer: CNPq)
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