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Study of Sensory Deficits in the Upper Limb After Stroke

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01685788
First Posted: September 14, 2012
Last Update Posted: October 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Katholieke Universiteit Leuven
Information provided by (Responsible Party):
Sarah Meyer, Universitaire Ziekenhuizen Leuven
  Purpose
The overall aim of the project is to gain insight in sensory deficits and recovery patterns in the upper limb post stroke and its association with brain lesion localisation. Furthermore, the investigators will identify associations of deficits in sensory modalities with upper limb impairments, activities and participation at different time points after stroke. Identification of the sensory deficits, along with further insights in their relation with objective neurophysiological and neuroanatomical measures will contribute to the amelioration of goal-setting for the rehabilitation of upper extremity function after stroke. These functions are indispensable during several daily activities as well in different sports and leisure activities. This project is an important step towards a better delineating of treatment interventions for the upper limb and to a better guiding of individual needs for post-stroke treatment in the future.

Condition Intervention
Stroke Other: No intervention

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Longitudinal Study: Sensory Deficits in the Upper Limb After Stroke.

Further study details as provided by Sarah Meyer, Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Change in sensory function in upper limb from baseline up to 6 months post stroke [ Time Frame: 6 months post stroke ]

Secondary Outcome Measures:
  • Change in motor function in upper limb from baseline up to 6 months post stroke [ Time Frame: 6 months post stroke ]

Other Outcome Measures:
  • activity measure [ Time Frame: 6 months post stroke ]
    The investigators will use the ABILHAND Questionnaire, a measure of how well the hemiplegic arm and hand can be used in daily activities.

  • Activity measure [ Time Frame: 6 months after stroke ]
    The Assisting Hand Assessment (AHA) will be used to investigate the use of the hemiplegic arm in bimanual tasks after stroke.

  • Participation measure [ Time Frame: 6 months after stroke ]
    The quality of life will be measured using the Stroke Impact Scale.


Enrollment: 40
Study Start Date: October 2012
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
study participants Other: No intervention

  Eligibility

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
stroke patients
Criteria

Inclusion Criteria:

  • first-ever stroke as defined by WHO
  • ≤ 5 days post stroke
  • motor impairment and/or a sensory impairment
  • ≥ 18 years old
  • sufficient cooperation to execute evaluations

Exclusion Criteria:

  • other neurological impairments such as previous stroke, head injury or multiple sclerosis (these might affect sensory ability independently of the stroke)
  • stroke-like symptoms caused by subdural hematoma, tumour, encephalitis or trauma
  • no informed consent
  • pre-stroke Barthel Index < 95 out of 100 points (to be able to distinguish between pre-existing disabilities and disabilities resulting from the 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): NCT01685788


Locations
Belgium
UZ Leuven
Leuven, Belgium
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Katholieke Universiteit Leuven
Investigators
Principal Investigator: Geert Verheyden, Professor Catholic University Leuven
Principal Investigator: Sarah Meyer, PhD student Catholic University Leuven
  More Information

Responsible Party: Sarah Meyer, PhD Student, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01685788     History of Changes
Other Study ID Numbers: KUL - FaBeR - Stroke - Meyer
First Submitted: September 6, 2012
First Posted: September 14, 2012
Last Update Posted: October 26, 2016
Last Verified: October 2016

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