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Completed

NCT Number: NCT02017093

Error Enhancement of the Velocity Component

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiparesis Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reuth Medical Center

Tel Aviv, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Error Enhancement

Device

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.

Other names: Experimental: Error Enhancement of the Velocity Component

Control Treatment

Device

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 outcomes

  1. Improvement in Average Movement Trajectory 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).

    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.

  2. Fugl-Meyer Assessment Score

    Time frame: The measured assessed at the begining of the rehabilitation (T1) and about 5 weeks later at the end of the rehabilitation (T2).

    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.

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Collaborators

  • Ben-Gurion University of the Negev
  • Tel Aviv University

Registry information

Official study title

Error Enhancement of the Velocity Component in the Course of Stroke Patients' Reaching Movements - A Pilot Study

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Dec 20, 2013
Registry last updated
Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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