Clinical trial NCT01988220: The Effects of Lower Extremity Sensory Retraining Treatment in Individuals With Post-stroke Sensory Impairment
Official title: The Effects of Lower Extremity Sensory Retraining Treatment in Individuals With Post-stroke Sensory Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Sensory Deficits
Keywords: stroke
sensory deficit
sensory retraining
perceptual learning
lower extremity
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Clalit Health Services, Haifa and West Galilee
First posted: 2013-11-20
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Timed Up and Go test
timeFrame: pre - up to a week before intervention, post - after 6 weeks, follow-up - 3 months after
Secondary outcomes:
measure: Von Frey monofilaments foot identification threshold
timeFrame: screening - one week before pretest, pre - up to one week before intervention, post - 6 weeks after, follow-up - 3 months after
Other outcomes:
Locations:
city: Haifa District
country: Israel
facility: Physical therapy clinics Clalit Health services
Study officials:
affiliation: Clalit Health Services
name: Mordechai Alperin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Haifa
name: Hadas Ofek, PhD student
role: STUDY_DIRECTOR
affiliation: University of Haifa
name: Yocheved Laufer, Professor
role: STUDY_CHAIR
affiliation: Clalit Health Services
name: Uzi Milman, MD
role: STUDY_CHAIR
References: