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.

Study Overview

• Status: Completed
• Conditions: Stroke; Sensory Deficits
• Intervention / Treatment: Other: sensory retraining; Other: repeated sensory input

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa District, Israel
    • Physical therapy clinics Clalit Health services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sensory retraining; sensory identification and discrimination training. using different attention and sensation modalities for sensory retraining	Other: sensory retraining; Other Names: perceptual learning; sensory reeducation
Active Comparator: repeated exposure to sensory input	Other: repeated sensory input; sensory stimulation without attentive learning focus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Von Frey monofilaments foot identification threshold	Assessment of threshold for Von Frey monofilaments identification, using the levels method. Starting with monofilament 5.07, two points will be assessed - dorsal mid foot and anterior mid ankle.	screening - one week before pretest, pre - up to one week before intervention, post - 6 weeks after, follow-up - 3 months after

Collaborators and Investigators

• Sponsor: Yocheved Laufer
• Collaborators: Clalit Health Services, Haifa and West Galilee
• Investigators: Principal Investigator: Mordechai Alperin, MD, Clalit health services; Study Director: Hadas Ofek, PhD student, University of Haifa; Study Chair: Yocheved Laufer, Professor, University of Haifa; Study Chair: Uzi Milman, MD, Clalit health services

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: November 5, 2013
• First Submitted That Met QC Criteria: November 13, 2013
• First Posted (Estimate): November 20, 2013

Study Record Updates

• Last Update Posted (Actual): May 3, 2018
• Last Update Submitted That Met QC Criteria: May 2, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: stroke; lower extremity; sensory deficit; sensory retraining; perceptual learning
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: UHai012013