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Sponsor study identifier
interventional
64
1 country
1
Study Start
December 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2017
Actual (reported)Study Completion
December 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2017
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 5, 2013
Actual (reported)November 20, 2013
Actual (reported)December 2014
Date type not reportedThis date has not been verified as actual or estimated.
November 2017
Actual (reported)December 2017
Actual (reported)Change in Timed Up and Go test
Standing up from a chair, walking three meters, turning around and coming back to sitting. time is assessed.
pre - up to a week before intervention, post - after 6 weeks, follow-up - 3 months after
Von Frey monofilaments foot identification threshold
screening - one week before pretest, pre - up to one week before intervention, post - 6 weeks after, follow-up - 3 months after
sensory identification and discrimination training. using different attention and sensation modalities for sensory retraining
sensory stimulation without attentive learning focus
Physical therapy clinics Clalit Health services
Haifa District, Israel
Ofek H, Alperin M, Knoll T, Livne D, Laufer Y. Explicit versus implicit lower extremity sensory retraining for post-stroke chronic sensory deficits: a randomized controlled trial. Disabil Rehabil. 2023 Jun;45(12):1962-1968. doi: 10.1080/09638288.2022.2080288. Epub 2022 Jun 1.
Mordechai Alperin, MD
Clalit Health Services
Hadas Ofek, PhD student
University of Haifa
Yocheved Laufer, Professor
University of Haifa
Uzi Milman, MD
Clalit Health Services
64 participants (actual enrollment reported by the registry).
First Submitted
November 5, 2013
First Posted
November 20, 2013
Study Start
December 2014
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 2017
Actual (reported)Study Completion
December 2017
Actual (reported)Last Updated
May 3, 2018
Record last verified: 2018-05
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Source: ClinicalTrials.gov.
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