Life Balance and Bimanual Activities After Stroke

NCT ID: NCT02650960

Last Updated: 2018-10-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 92 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-10-31

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.

Conditions

Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Geert Verheyden

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geert Verheyden

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

RevArte

Antwerp, , Belgium

Jessa Hospitals

Herk-de-Stad, , Belgium

UZ LEuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

S58670

Identifier Type: -

Identifier Source: org_study_id