Motor Adaptation by Error Augmentation Force Field in Healthy Peoples' Upper Extremity

• ClinicalTrials.gov Identifier: NCT02780817
• Recruitment Status: Unknown
• First Posted: May 24, 2016
• Last Update Posted: May 24, 2016
• Sponsor: University of Haifa
• Information provided by (Responsible Party): University of Haifa

Study Description

Brief Summary:

Inducing a systematic perturbation forces on the hand during arm reaching movement may improve adaptation. Error-augmentation (EA) training is relatively new concept in motor learning intended to promote the adaptation process. In this study participants will practice one session of training on 3D robotic device. Healthy volunteers will be randomly divided into two groups: study and control. The study group will carry out the training session with EA forces. The control group will carry out the same procedure with null force field. Outcome measure are the average size of trajectory error from the straight line and level of exertion (borg scale).

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers	Other: Error enhancement; Other: Control group	Not Applicable

Detailed Description:

A single process involved in motor learning is adaptation. Hand reaching movement has been extensively used to evaluate the concept of motor adaptation. By inducing a systematic perturbation on the hand, it is possible to examine the implicit motor response on the trajectory of the hand. Error-augmentation (EA) training is relatively new concept in motor learning intended to promote the adaptation process. Applying these perturbating forces on the hand shift the hand trajectory form the straight line to a curve like shape. Making repetitive movement under the same conditions will results in a gradual correction of this faulty movement trajectory toward the straight line, e.g. motor adaptation.

Participants: Healthy volunteers, aged 20-50, males and females. The participants will be randomly assigned into two groups: study or control group.

Procedure: One practice session of 25 minutes on 3D robotic device. The study group will carry out the session with EA forces. The control group will carry out the same training without the EA forces.

Outcome Measures: Size of trajectory error from the straight line, level of exertion.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Motor Adaptation by Error Augmentation Force Field in Healthy Peoples' Upper Extremity, a Randomized Controlled Trial
• Study Start Date: December 2015
• Estimated Primary Completion Date: May 2017
• Estimated Study Completion Date: May 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Error enhancement; Arm reaching rehabilitation training with error-augmentation perturbation forces. One session of about 25 minutes of practicing arm reaching movements on 3D robotic device.	Other: Error enhancement; Participants will sit in front of a 3D robotic device and grab the robotic arm handle. The participants will carry out arm reaching tasks appear on a screen on front of them. Each game of tasks will lasts 2 minutes. The participants will carry out one game to be accustomed to device, followed by one game with null force field, followed by 5 games as the main intervention with error enhancement force field, and another last game with null force field.
Control group; Arm reaching rehabilitation training without error-augmentation perturbation forces. One session of about 25 minutes of practicing arm reaching movements on 3D robotic device.	Other: Control group; Participants will sit in front of a 3D robotic device and grab the robotic arm handle. The participants will carry out arm reaching tasks appear on a screen on front of them. Each game of tasks will lasts 2 minutes. The participants will carry out one game to be accustomed to device and another 7 games with null force field.

Outcome Measures

Primary Outcome Measures :

1. Change in average movement error from baseline [ Time Frame: At baseline, before the beginning of the training session, and at followup measurement immediately at the the end of the training session, which is about 45 minutes after the first evaluation. ]
   Average size of trajectory error form the straight line while making arm reaching movement

Secondary Outcome Measures :

1. Change in Borg scale score from baseline [ Time Frame: At baseline, before the beginning of the training session, and at followup measurement immediately at the end of the training session, which is about 45 minutes after the first evaluation. ]
   A 6-20 scale that intended describe the subjective level of exertion of the participant.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Healthy

Exclusion Criteria:

• Neurologic disease, orthopedic syndrome of the dominant upper extremity.

Contacts and Locations

Contacts

Contact: Sharon Israley, MSc.; 972-523-755-091; sharonis@mh.org.il

Contact: Eli Carmeli, PhD.; ecarmeli@univ.haifa.ac.il

Locations

Israel

University of Haifa; Recruiting

Haifa, Israel

Contact: Eli Carmeli, PhD 972-04-8288397 ecarmeli@univ.haifa.ac.il

Principal Investigator: Eli Carmeli, PhD.

Sub-Investigator: Sharon Israely, MSc.

Sponsors and Collaborators

University of Haifa

Investigators

• Principal Investigator: Eli Carmeli, PhD.; Professor

More Information

• Responsible Party: University of Haifa
• ClinicalTrials.gov Identifier: NCT02780817
• Other Study ID Numbers: 036/15
• First Posted: May 24, 2016
• Last Update Posted: May 24, 2016
• Last Verified: May 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Journal article