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

Not Applicable

Completed

• Conditions: Sensory Deficits; Stroke
• Interventions: Other: repeated sensory input; Other: sensory retraining

• Registration Number: NCT01988220
• Lead Sponsor: Yocheved Laufer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-05
• Study First Submitted QC: 2013-11-13
• Study First Posted: 2013-11-20
• Study Start: 2014-12
• Primary Completion: 2017-11
• Study Completion: 2017-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
repeated exposure to sensory input	repeated sensory input	-
sensory retraining	sensory retraining	sensory identification and discrimination training. using different attention and sensation modalities for sensory retraining

Primary Outcome Measures

Name	Time	Method
Change in Timed Up and Go test	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 Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Physical therapy clinics Clalit Health services; 🇮🇱 Haifa District, Israel