- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02650960
Life Balance and Bimanual Activities After Stroke
The Flemish version of the Life Balance Inventory (LBI), measuring central constructs of life balance, will be validated in a stroke population. Upon approval by the ethical committee, stroke patients will be recruited when they are at least six months post stroke (n = 30). The LBI will be administered twice with one week interval, and demographic, socio-economic variables and other measures of health related quality of life will be collected.
Next, an observational prospective longitudinal study will be set up. We will recruit stroke patients in three rehabilitation centers within one week after admission in the rehabilitation center. Patients will undergo a baseline evaluation and will be re-assessed at discharge from the rehabilitation center, at six months and at 12 months post stroke. A standardized clinical assessment battery, measuring motor, sensory, cognitive, mental and functional outcomes as well as personal and environmental factors will be administered. This observational study will explore recovery patterns of bimanual activities after stroke from baseline evaluation to six and 12 months after stroke. Also the predictive value of motor, sensory, cognitive and mental outcomes on bimanual activities at six and 12 months post stroke is studied, based on data collected on admission to the rehabilitation center. Finally, changes over time in life balance and its determinants will be examined at six and 12 months post stroke. The predictive value of motor, cognitive and functional outcomes on life balance at one year post stroke will be examined, based on data collected on admission to the rehabilitation center. Furthermore the influence of bimanual activities on life balance will be explored in the chronic stage after stroke.
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
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Antwerp, Belgia
- RevArte
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Herk-de-Stad, Belgia
- Jessa Hospitals
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Leuven, Belgia
- UZ Leuven
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- first-ever stroke, as defined by the WHO criteria
- assessed and included within the first week after admission in the rehabilitation center and within the first six weeks after stroke onset
- unilateral motor impairment in the upper limb (UL - Fügl-Meyer score ≤ 60)
- minimally 18 years old
- substantial cooperation to perform the assessments
- written informed consent
Exclusion Criteria:
- other neurological impairments with permanent damage such as multiple sclerosis or Parkinson's disease
- a subdural hematoma, tumor, encephalitis or trauma that lead to similar symptoms as a stroke
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Adult Assisting Hand Assessment - Stroke
Tidsramme: 12 months post stroke
|
observation based performance assessment
|
12 months post stroke
|
Life Balance Inventory
Tidsramme: 12 months post stroke
|
questionnaire
|
12 months post stroke
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Geert Verheyden, KU Leuven
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
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 (Faktiske)
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
- S58670
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