Error Enhancement of the Velocity Component
2 other identifiers
interventional
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Jan 2009
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 20, 2013
CompletedFirst Posted
Study publicly available on registry
December 20, 2013
CompletedResults Posted
Study results publicly available
January 13, 2016
CompletedJanuary 13, 2016
June 1, 2015
3.5 years
June 20, 2013
May 27, 2015
December 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
The outcome was assessed at the begining of the rehabilitation (T1) and about 5 weeks later at the end of rehabilitation (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.
The measured assessed at the begining of the rehabilitation (T1) and about 5 weeks later at the end of the rehabilitation (T2).
Study Arms (2)
Error Enhancement
EXPERIMENTALTraining of the upper extremity, using a robotic devise with error enhanced forces and traditional therapy.
Control treatment
EXPERIMENTALTraining of the upper extremity, using a robotic devise without forces applied and traditional therapy.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Perceptual, apraxic, or major cognitive deficits,
- Shoulder joint subluxation or pain in the upper-limb, and
- Spasticity \> 1 (single muscle Modified Ashworth Scale).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Haifalead
- Ben-Gurion University of the Negevcollaborator
- Tel Aviv Universitycollaborator
Study Sites (1)
Reuth Medical Center
Tel Aviv, Israel
Related Publications (1)
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.
RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof. Eli Carmeli
- Organization
- University of Haifa
Study Officials
- PRINCIPAL INVESTIGATOR
Eli Carmeli, PhD
University of Haifa
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
June 20, 2013
First Posted
December 20, 2013
Study Start
January 1, 2009
Primary Completion
July 1, 2012
Study Completion
May 1, 2013
Last Updated
January 13, 2016
Results First Posted
January 13, 2016
Record last verified: 2015-06