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Error Enhancement of the Velocity Component

Primary Purpose

Stroke, Hemiparesis

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Error Enhancement
control treatment
Sponsored by
University of Haifa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stroke focused on measuring CVA, rehabilitation

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Single stroke
  • Two to three weeks post Stroke
  • Able to understand simple commands
  • Able to perform some reaching movements with the affected arm.
  • No other neurological, neuromuscular, orthopedic disorders and visual deficit

Exclusion Criteria:

  • Perceptual, apraxic, or major cognitive deficits,
  • Shoulder joint subluxation or pain in the upper-limb, and
  • Spasticity > 1 (single muscle Modified Ashworth Scale).

Sites / Locations

  • Reuth Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Error Enhancement

Control treatment

Arm Description

Training of the upper extremity, using a robotic devise with error enhanced forces and traditional therapy.

Training of the upper extremity, using a robotic devise without forces applied and traditional therapy.

Outcomes

Primary Outcome Measures

Improvement in Average Movement Trajectory Error From T1 to T2
While reaching, people have typical movement pattern of trajectory, moving the end-effector (hand) in straight line. The abnormal motor control after a stroke may cause these patients to deviate from this pattern. Our robotic device enabled us to measure the magnitude of the deviation from the optimal profile of healthy people. This was followed by a calculation of the average error the paricipants made in each treatment session. So we finally recieved a score of the average magnitude of trajectory error the participants made through a treatment session. Each treatment seesoin composed of about 100 reaching movements. The outcome measure expresses the change in the movement error from T1 to T2.
Fugl-Meyer Assessment Score
The Fugl-Meyer assessment score (FM) is a zero (disabaled function) to 66 points (high level of function) scale that evaluates the level of the motor impairment of the upper extremity, in stroke patients.

Secondary Outcome Measures

Full Information

First Posted
June 20, 2013
Last Updated
December 9, 2015
Sponsor
University of Haifa
Collaborators
Ben-Gurion University of the Negev, Tel Aviv University
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1. Study Identification

Unique Protocol Identification Number
NCT02017093
Brief Title
Error Enhancement of the Velocity Component
Official Title
Error Enhancement of the Velocity Component in the Course of Stroke Patients' Reaching Movements - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Haifa
Collaborators
Ben-Gurion University of the Negev, Tel Aviv University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this pilot study was to explore the impact of enhancement of the velocity component error in the course of reaching movements of the impaired/hemiparetic limb in an acute stroke subject. We hypothesized that the method would shift velocity profiles toward the optimal, resulting in a reduction in error. A prototype robot. This robotic device system has a two-dimensional motor, basic measurement capacities, and a robotic arm which is engaged to the subject's upper-limb in a sitting position. The enhancement of the velocity component error would shift velocity profiles toward the optimal, resulting in a reduction in error.
Detailed Description
The wrist of the subject is connected to the robotic arm by a strip which supports the arm but allows free movements of the wrist. This configuration allows subjects with impaired grasping ability to use the system. A bio-feedback system enables the subject to perform various functional motor tasks that are presented on the screen in front of him. The system's sensors detect motor errors or deviations from an optimal/proper movement trajectory or velocity profile. Any deviation in direction, velocity, acceleration or necessary force from the optimal trajectory results in applied robotic forces that enhance such errors/deviations. The sensors and the applied forces all work and compute in real time, so that the force measurements and the applied force are updated to the executed movement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis
Keywords
CVA, rehabilitation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Error Enhancement
Arm Type
Experimental
Arm Description
Training of the upper extremity, using a robotic devise with error enhanced forces and traditional therapy.
Arm Title
Control treatment
Arm Type
Experimental
Arm Description
Training of the upper extremity, using a robotic devise without forces applied and traditional therapy.
Intervention Type
Device
Intervention Name(s)
Error Enhancement
Other Intervention Name(s)
Experimental: Error Enhancement of the Velocity Component
Intervention Description
Patients underwent upper extremity robotic training with the error enhancement effect. Training have focused on hand reaching movements in varity of directions and range of motions.
Intervention Type
Device
Intervention Name(s)
control treatment
Intervention Description
Patients underwent upper extremity robotic training without the error enhancement effect. Training have focused on hand reaching movements in varity of directions and range of motions.
Primary Outcome Measure Information:
Title
Improvement in Average Movement Trajectory Error From T1 to T2
Description
While reaching, people have typical movement pattern of trajectory, moving the end-effector (hand) in straight line. The abnormal motor control after a stroke may cause these patients to deviate from this pattern. Our robotic device enabled us to measure the magnitude of the deviation from the optimal profile of healthy people. This was followed by a calculation of the average error the paricipants made in each treatment session. So we finally recieved a score of the average magnitude of trajectory error the participants made through a treatment session. Each treatment seesoin composed of about 100 reaching movements. The outcome measure expresses the change in the movement error from T1 to T2.
Time Frame
The outcome was assessed at the begining of the rehabilitation (T1) and about 5 weeks later at the end of rehabilitation (T2).
Title
Fugl-Meyer Assessment Score
Description
The Fugl-Meyer assessment score (FM) is a zero (disabaled function) to 66 points (high level of function) scale that evaluates the level of the motor impairment of the upper extremity, in stroke patients.
Time Frame
The measured assessed at the begining of the rehabilitation (T1) and about 5 weeks later at the end of the rehabilitation (T2).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Single stroke Two to three weeks post Stroke Able to understand simple commands Able to perform some reaching movements with the affected arm. No other neurological, neuromuscular, orthopedic disorders and visual deficit Exclusion Criteria: Perceptual, apraxic, or major cognitive deficits, Shoulder joint subluxation or pain in the upper-limb, and Spasticity > 1 (single muscle Modified Ashworth Scale).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eli Carmeli, PhD
Organizational Affiliation
University of Haifa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reuth Medical Center
City
Tel Aviv
Country
Israel

12. IPD Sharing Statement

Citations:
Citation
Givon-Mayo R, Simons E, Ohry A, Karpin H, Israely S, Carmeli E. A preliminary investigation of error enhancement of the velocity component in stroke patients' reaching movements. International Journal of Therapy and Rehabilitation. 2014;21(4):160-168.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/16249912
Description
Click here for more information about this study: http://www.ncbi.nlm.nih.gov/pubmed/18326055

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Error Enhancement of the Velocity Component

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