The Effects of Lower Extremity Sensory Retraining Treatment in Individuals With Post-stroke Sensory Impairment
Study Details
Study Description
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:
- 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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:
|
| Active Comparator: repeated exposure to sensory input
|
Other: repeated sensory input
sensory stimulation without attentive learning focus
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Physical therapy clinics Clalit Health services | Haifa District | Israel |
Sponsors and Collaborators
- Yocheved Laufer
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- UHai012013