NCT02017093

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

January 13, 2016

Completed
Last Updated

January 13, 2016

Status Verified

June 1, 2015

Enrollment Period

3.5 years

First QC Date

June 20, 2013

Results QC Date

May 27, 2015

Last Update Submit

December 9, 2015

Conditions

Keywords

CVA, rehabilitation

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

EXPERIMENTAL

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

Device: Error Enhancement

Control treatment

EXPERIMENTAL

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

Device: control treatment

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.

Also known as: Experimental: Error Enhancement of the Velocity Component
Error Enhancement

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.

Control treatment

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Reuth Medical Center

Tel Aviv, Israel

Location

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

StrokeParesis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Prof. Eli Carmeli
Organization
University of Haifa

Study Officials

  • Eli Carmeli, PhD

    University of Haifa

    PRINCIPAL INVESTIGATOR

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

Locations