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OpenTrials
Completed

NCT Number: NCT01685788

Study of Sensory Deficits in the Upper Limb After Stroke

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Change in sensory function in upper limb from baseline up to 6 months post stroke

    Time frame: 6 months post stroke

Secondary outcomes

  1. Change in motor function in upper limb from baseline up to 6 months post stroke

    Time frame: 6 months post stroke

Other outcomes

  1. 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.

  2. 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.

  3. Participation measure

    Time frame: 6 months after stroke

    The quality of life will be measured using the Stroke Impact Scale.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • KU Leuven

Registry information

Official study title

Prospective Longitudinal Study: Sensory Deficits in the Upper Limb After Stroke.

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 14, 2012
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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