- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02780817
Motor Adaptation by Error Augmentation Force Field in Healthy Peoples' Upper Extremity
Motor Adaptation by Error Augmentation Force Field in Healthy Peoples' Upper Extremity, a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sharon Israley, MSc.
- Phone Number: 972-523-755-091
- Email: sharonis@mh.org.il
Study Contact Backup
- Name: Eli Carmeli, PhD.
- Email: ecarmeli@univ.haifa.ac.il
Study Locations
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-
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Haifa, Israel
- Recruiting
- University of Haifa
-
Contact:
- Eli Carmeli, PhD
- Phone Number: 972-04-8288397
- Email: ecarmeli@univ.haifa.ac.il
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Principal Investigator:
- Eli Carmeli, PhD.
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Sub-Investigator:
- Sharon Israely, MSc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy
Exclusion Criteria:
- Neurologic disease, orthopedic syndrome of the dominant upper extremity.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
Other: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eli Carmeli, PhD., Professor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 036/15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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