Stroke Clinical Trial
Official title:
The Effects of Lower Extremity Sensory Retraining Treatment in Individuals With Post-stroke Sensory Impairment
Background: It is estimated that 50%-85% of individuals post stroke demonstrate sensory
deficits. Sensory impairments are often overlooked in the therapeutic setting, although they
lead to slower motor recovery.
Working hypothesis: The overall goal of this study is to examine the effectiveness of a
sensory discrimination reeducation oriented therapeutic program to the lower limb of stroke
patients with sensory impairments. We assume that subjects to both groups will make progress,
which will be more significant in the experimental group.
Methods: Study population and design: Sixty individuals with chronic sensory impairment
following a stroke will be recruited. Patients will be randomly assigned to sensory
retraining treatment or to sensory stimulation treatment. Treatment will consist of ten 45
minute long intervention sessions, carried out within a 6 weeks period, and a home exercise
program. The person conducting the assessments will be blind to the treatment allocation of
the subjects. Outcome measures: The efficacy of the intervention will be determined in
relation to the International Classification of Functionality (ICF) developed by the World
Health Organization and will include assessments at the three domains defined by this model:
1. Body structure and function - determined by measures of the sensory capacity of the lower
more affected limb; 2. Activities - determined by measures of balance and gait; 3.
Participation - determined by measures of well-being and social reintegration.
Two new outcome measures, for ankle and knee position sense and for texture discrimination of
the foot, will be developed within this study. Data reliability measures on healthy
population, and test - retest measures in post stroke population with be collected.
Intervention: The experimental group will be treated by a perception learning oriented
protocol for sensory reeducation, to improve identification, localization and discrimination
of sensory stimuli, including electrical stimulation, texture and hardness discrimination and
position sense training. The control group will receive the same stimuli without the
attentive learning and discriminating component.
Importance: Scientific proof and focused recommendations for a potent therapeutic method for
the post-stroke population, allowing them better participation and quality of life.
Key words: Stroke, sensory impairment, perceptual learning, lower limb, clinical trial.
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