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Clinical Trials/NCT01988220
NCT01988220
Completed
N/A

The Effects of Lower Extremity Sensory Retraining Treatment in Individuals With Post-stroke Sensory Impairment

Yocheved Laufer1 site in 1 country64 target enrollmentDecember 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Yocheved Laufer
Enrollment
64
Locations
1
Primary Endpoint
Change in Timed Up and Go test
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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
clinicaltrials.gov
Start Date
December 2014
End Date
December 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Yocheved Laufer
Responsible Party
Sponsor Investigator
Principal Investigator

Yocheved Laufer

Chair, Physical Therapy Department

University of Haifa

Eligibility Criteria

Inclusion Criteria

  • post stroke
  • at least 6 months after stroke
  • with sensory deficits in study's screening tests

Exclusion Criteria

  • other neurologic condition
  • peripheral neuropathy
  • pacemaker
  • hemispatial neglect

Outcomes

Primary Outcomes

Change in Timed Up and Go test

Time Frame: pre - up to a week before intervention, post - after 6 weeks, follow-up - 3 months after

Standing up from a chair, walking three meters, turning around and coming back to sitting. time is assessed.

Secondary Outcomes

  • 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)

Study Sites (1)

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