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Life Balance and Bimanual Activities After Stroke

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ClinicalTrials.gov Identifier: NCT02650960
Recruitment Status : Recruiting
First Posted : January 8, 2016
Last Update Posted : July 13, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease

Study Design

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Life Balance and Bimanual Activities After Stroke
Study Start Date : February 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2018
Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Adult Assisting Hand Assessment - Stroke [ Time Frame: 12 months post stroke ]
    observation based performance assessment

  2. Life Balance Inventory [ Time Frame: 12 months post stroke ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02650960

Contact: Annick Van Gils annick.vangils@kuleuven.be

RevArte Recruiting
Antwerp, Belgium
Contact: Annick Van Gils, MSc         
Jessa Hospitals Recruiting
Herk-de-Stad, Belgium
Contact: Annick Van Gils, MSc         
UZ LEuven Recruiting
Leuven, Belgium
Contact: Annick Van Gils, MSc         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Principal Investigator: Geert Verheyden KU Leuven
More Information

Responsible Party: Geert Verheyden, Professor, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02650960     History of Changes
Other Study ID Numbers: S58670
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases