Life Balance and Bimanual Activities After Stroke

Stroke Clinical Trial

Official title:

Life Balance and Bimanual Activities After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02650960
• Other study ID #: S58670
• Status: Completed
• Start date: February 2016
• Est. completion date: October 2018

Study information

• Verified date: October 2018
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: October 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
Belgium	RevArte	Antwerp
Belgium	Jessa Hospitals	Herk-de-Stad
Belgium	UZ LEuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adult Assisting Hand Assessment - Stroke	observation based performance assessment	12 months post stroke
Primary	Life Balance Inventory	questionnaire	12 months post stroke