Error Augmentation Training Post Stroke
Upper Extremity Training by Error Augmentation in Post-stroke Individuals
Post-stroke individuals continue to suffer from significant motor impairments years after the stroke. Motor recovery is usually limited to the first 6 month after the stroke, in which the majority of improvements occur at the first three months. Error augmentation (EA) training using a robotic apparatus was suggested to enhance motor recovery by exploiting the adaptation mechanisms within the intact cerebellum in individuals who sustained cortical stroke.
The aim of this study is to investigate whether error augmentation training for the upper extremity may enhance motor recovery in individuals that sustained cortical stroke.
Fifty post-stroke individuals will be randomaly assigned into either EA training (study group- SG) or robotic training in null field environment (control group- CG). Both groups will carry out the same treatment protocol on the robotic device in addition to the standard rehabilitation protocol of the rehabilitation center. Treatment protocol will be consisted of about six training sessions on the robotic device, taken twice or three times a week for two to three weeks. Each training session will be composed of 20-30 minutes upper extremity training with or without EA force field.
Motor performance will be evaluated before and after the treatment protocol by the Fugl-Meyer Assessment scale.
Study Overview
Detailed Description
Post-stroke individuals continue to suffer from significant motor impairments years after the stroke. Motor recovery is usually limited to the first 6 month after the stroke, in which the majority of improvements occur at the first three months. Error augmentation (EA) training using a robotic apparatus was suggested to enhance motor recovery by exploiting the adaptation mechanisms within the intact cerebellum in individuals who sustained cortical stroke.
The aim of this study is to investigate whether error augmentation training for the upper extremity may enhance motor recovery in individuals that sustained cortical stroke.
Fifty post-stroke individuals will be randomaly assigned into either EA training (study group- SG) or robotic training in null field environment (control group- CG). Both groups will carry out the same treatment protocol on the robotic device in addition to the standard rehabilitation protocol of the rehabilitation center. Treatment protocol will be consisted of about six training sessions on the robotic device, taken twice or three times a week for two to three weeks. Each training session will be composed of 20-30 minutes upper extremity training with or without EA force field.
Motor performance will be evaluated before and after the treatment protocol by the Fugl-Meyer Assessment scale.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nesher, Israel
- Recruiting
- Bait Balev
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Contact:
- Oxana Zalsov, MD
- Phone Number: 972-73-2377315
- Email: oxana_za@bbalev.co.il
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Cortical stroke, unilateral hemiparesis
Exclusion Criteria:
- other neurological disorders (Alzheimer's disease, PD), complete plegia,unilateral neglect,sensory aphasia, Mini Mental State Examination<20
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study Group
Training of the upper extremity on a robotic device. Participants will carry out hand reaching movement for multiple directions in 3 dimensions, while grasping the robotic handle according to assignments given by the robotic device. During training the robotic device will apply error augmentation force-field to perturbate the arm of the participant away from the straight trajectory line. |
Upper extremity training on a robotic device with or without error augmentation force field.
|
|
Experimental: Control group
Training of the upper extremity on a robotic device. Participants will carry out hand reaching movement for multiple directions in 3 dimensions, while grasping the robotic handle according to assignments given by the robotic device. During training the robotic device will not apply any perturbations on the participant's arm. |
Upper extremity training on a robotic device with or without error augmentation force field.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fugl-Meyer Assessment Scale
Time Frame: Baseline
|
Clinical test for the assessment of motor impairments of the upper extremity
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Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Eli Carmeli, PhD, Professor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHaifa062018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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