Error Augmentation Training Post Stroke

Stroke Clinical Trial

Official title:

Upper Extremity Training by Error Augmentation in Post-stroke Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03578250
• Other study ID #: UHaifa062018
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: June 2018
• Source: University of Haifa
• Contact: Eli Carmeli, PhD
• Phone: 972-04-8288397
• Email: ecarmeli[@]univ.haifa.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Robotic Training
Upper extremity training on a robotic device with or without error augmentation force field.

Locations

Country	Name	City	State
Israel	Bait Balev	Nesher

Sponsors (1)

Lead Sponsor	Collaborator
University of Haifa

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment Scale	Clinical test for the assessment of motor impairments of the upper extremity	Baseline