MedPath

Error Augmentation Training Post Stroke

Not Applicable
Conditions
Stroke
Interventions
Other: Robotic Training
Registration Number
NCT03578250
Lead Sponsor
University of Haifa
Brief 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.

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
50
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Study GroupRobotic TrainingTraining 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.
Control groupRobotic TrainingTraining 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.
Primary Outcome Measures
NameTimeMethod
Fugl-Meyer Assessment ScaleBaseline

Clinical test for the assessment of motor impairments of the upper extremity

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Bait Balev

🇮🇱

Nesher, Israel

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