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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988220
• Other study ID #: UHai012013
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: December 2017

Study information

• Verified date: May 2018
• Source: University of Haifa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypesthesia
• Sensory Deficits
• Stroke

Intervention

Other:
• sensory retraining

• repeated sensory input
sensory stimulation without attentive learning focus

Locations

Country	Name	City	State
Israel	Physical therapy clinics Clalit Health services	Haifa District

Sponsors (2)

Lead Sponsor	Collaborator
Yocheved Laufer	Clalit Health Services, Haifa and West Galilee

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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