Clinical trial NCT02650960: Life Balance and Bimanual Activities After Stroke
Official title: Life Balance and Bimanual Activities After Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a first-ever stroke (n=120) will be recruited consecutively by admission in three rehabilitation centers in Belgium.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Adult Assisting Hand Assessment - Stroke
timeFrame: 12 months post stroke
measure: Life Balance Inventory
timeFrame: 12 months post stroke
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: RevArte
city: Herk-de-Stad
country: Belgium
facility: Jessa Hospitals
city: Leuven
country: Belgium
facility: UZ LEuven
Study officials:
affiliation: KU Leuven
name: Geert Verheyden
role: PRINCIPAL_INVESTIGATOR
References: