Life Balance and Bimanual Activities After Stroke

NCT02650960 | Completed

• 1 other identifier: S58670
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (2)

• Adult Assisting Hand Assessment - Stroke

  observation based performance assessment

  12 months post stroke

• Life Balance Inventory

  questionnaire

  12 months post stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (3)

RevArte

Antwerp, Belgium

Location

Jessa Hospitals

Herk-de-Stad, Belgium

Location

UZ LEuven

Leuven, Belgium

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Geert Verheyden

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: January 8, 2016
• Study Start: February 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2018
• Last Updated: October 30, 2018

Record last verified: 2018-10

Locations

BE (3)