The Effects of Lower Extremity Sensory Retraining Treatment in Individuals With Post-stroke Sensory Impairment
Primary Purpose
Stroke, Sensory Deficits
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
sensory retraining
repeated sensory input
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, sensory deficit, sensory retraining, perceptual learning, lower extremity
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
Sites / Locations
- Physical therapy clinics Clalit Health services
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
sensory retraining
repeated exposure to sensory input
Arm Description
sensory identification and discrimination training. using different attention and sensation modalities for sensory retraining
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01988220
First Posted
November 5, 2013
Last Updated
May 2, 2018
Sponsor
Yocheved Laufer
Collaborators
Clalit Health Services, Haifa and West Galilee
1. Study Identification
Unique Protocol Identification Number
NCT01988220
Brief Title
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
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yocheved Laufer
Collaborators
Clalit Health Services, Haifa and West Galilee
4. Oversight
Data Monitoring Committee
No
5. 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: 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Sensory Deficits
Keywords
stroke, sensory deficit, sensory retraining, perceptual learning, lower extremity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sensory retraining
Arm Type
Experimental
Arm Description
sensory identification and discrimination training. using different attention and sensation modalities for sensory retraining
Arm Title
repeated exposure to sensory input
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
sensory retraining
Other Intervention Name(s)
perceptual learning, sensory reeducation
Intervention Type
Other
Intervention Name(s)
repeated sensory input
Intervention Description
sensory stimulation without attentive learning focus
Primary Outcome Measure Information:
Title
Change in Timed Up and Go test
Description
Standing up from a chair, walking three meters, turning around and coming back to sitting. time is assessed.
Time Frame
pre - up to a week before intervention, post - after 6 weeks, follow-up - 3 months after
Secondary Outcome Measure Information:
Title
Von Frey monofilaments foot identification threshold
Description
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.
Time Frame
screening - one week before pretest, pre - up to one week before intervention, post - 6 weeks after, follow-up - 3 months after
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mordechai Alperin, MD
Organizational Affiliation
Clalit Health Services
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hadas Ofek, PhD student
Organizational Affiliation
University of Haifa
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yocheved Laufer, Professor
Organizational Affiliation
University of Haifa
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Uzi Milman, MD
Organizational Affiliation
Clalit Health Services
Official's Role
Study Chair
Facility Information:
Facility Name
Physical therapy clinics Clalit Health services
City
Haifa District
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Effects of Lower Extremity Sensory Retraining Treatment in Individuals With Post-stroke Sensory Impairment
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