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Error Augmentation Training Post Stroke

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Robotic Training
Sponsored by
University of Haifa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Error augmentation, Rehabilitation, Cerebellum, Motor learning, Adaptation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bait BalevRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Study Group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment Scale
Clinical test for the assessment of motor impairments of the upper extremity

Secondary Outcome Measures

Full Information

First Posted
June 25, 2018
Last Updated
June 25, 2018
Sponsor
University of Haifa
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1. Study Identification

Unique Protocol Identification Number
NCT03578250
Brief Title
Error Augmentation Training Post Stroke
Official Title
Upper Extremity Training by Error Augmentation in Post-stroke Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Haifa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Error augmentation, Rehabilitation, Cerebellum, Motor learning, Adaptation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Robotic Training
Intervention Description
Upper extremity training on a robotic device with or without error augmentation force field.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment Scale
Description
Clinical test for the assessment of motor impairments of the upper extremity
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eli Carmeli, PhD
Phone
972-04-8288397
Email
ecarmeli@univ.haifa.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eli Carmeli, PhD
Organizational Affiliation
Professor
Official's Role
Study Director
Facility Information:
Facility Name
Bait Balev
City
Nesher
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oxana Zalsov, MD
Phone
972-73-2377315
Email
oxana_za@bbalev.co.il

12. IPD Sharing Statement

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Error Augmentation Training Post Stroke

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