Hand Lateralization by Using EEG Analysis Method in Amputees

September 19, 2023 updated by: Burcu Dilek, Trakya University

Evaluation of Hand Lateralization Cognitive Task From Different Personal Perspectives by Using EEG Analysis Method in Amputees

Studies on the improvement of body image or body perception have proven their effectiveness in different clinical situations such as pain management and chronic pain treatment. The aim of this study is to evaluate the hand lateralization cognitive task by recording Electroencephalography (EEG) signals from different personal perspectives in amputees. In this study, the paradigm in which personal perspectives are evaluated over the hand lateralization task will be applied to amputees and healthy volunteer participants. Data will be recorded via EEG and Eprime software program.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to evaluate the hand lateralization cognitive task by recording Electroencephalography (EEG) signals from different personal perspectives in amputees.

In this study, the paradigm in which personal perspectives are evaluated over the hand lateralization task will be applied to amputees and healthy volunteer participants.

It was planned to enroll two groups to the study. One group is named "amputees" the other one is "control". Control group will be matched in terms of age and gender with the amputees group. Before hand lateralization test, participants will be evaluated regarding eligible criterias and EEG paradigm regarding hand lateralization will be performed for each participant.

Both groups (Amputees and Control) will complete "hand lateralization program" for at least 10 days. The test will be sent each day on an online system. Participants' performances will be recorded via online system.

Following 10-day period, EEG paradigm regarding hand lateralization will be performed for each participant, again.

Before and after comparisons will be analyzed. Data will be recorded via EEG and Eprime software program.

EEG-Event Related Oscillation (power spectrum, phase locking) analysis will be performed for each frequency bands: alpha, theta, beta, gamma.

Eprime analysis will be performed for the data of reaction time and accuracy rate.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Edirne, Turkey
        • Trakya University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Control group:

Inclusion Criteria:

  • being between ages 18-65,
  • consenting,
  • with no limitation in mobility or movement disorder,
  • A score of 21 or higher on the Montreal Cognitive Assessment Test

Exclusion Criteria:

  • refuse to attend to the study,
  • Having any mental, neurological or musculoskeletal problems,
  • Inability to perform activities that require long-term attention,
  • Inability to detect given commands,
  • Using sedative drugs and/or derivatives

Amputee group:

Inclusion Criteria:

  • between ages 18-65,
  • using prosthesis,
  • A score of 21 or higher on the Montreal Cognitive Assessment Test

Exclusion Criteria:

  • Having phantom pain,
  • Having open wound on stump,
  • Having any discomfort feeling on stump,
  • Having any mental, neurological or musculoskeletal problems,
  • Inability to perform activities that require long-term attention,
  • Inability to detect given commands,
  • Using sedative drugs and/or derivatives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: One of groups: amputees group
We planned to enroll two groups to the study. One group is named "amputees" the other one is "control". Both groups will enroll "hand lateralization" for at least 10 days. Before and after comparisons will be analyzed.
Behavioral: Hand Lateralization Test
Before hand lateralization test, participants will be evaluated. Both groups (Amputees and Control) will complete hand lateralization test for at least 10 days. The test will be sent each day on an online system. Participants' performances will be recorded via online system. After hand lateralization test, participants will be evaluated.
Active Comparator: One of groups: control group
Control group will be matched in terms of age and gender with the amputees group.
Behavioral: Hand Lateralization Test
Before hand lateralization test, participants will be evaluated. Both groups (Amputees and Control) will complete hand lateralization test for at least 10 days. The test will be sent each day on an online system. Participants' performances will be recorded via online system. After hand lateralization test, participants will be evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electroencephalogram (EEG) frequency bands: alpha, theta, beta, gamma
Time Frame: Before and after the hand lateralization test: 10-14 days
Changes in power spectrum and phase locking
Before and after the hand lateralization test: 10-14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reaction time to decide whether the hand is right or left
Time Frame: Before and after the hand lateralization test: 10-14 days
E-prime parameter: recorded as milisecond
Before and after the hand lateralization test: 10-14 days
Accuracy proportion of given answers regarding hand lateralization
Time Frame: Before and after the hand lateralization test: 10-14 days
E-prime parameter: recorded as percentage
Before and after the hand lateralization test: 10-14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trakya University

Collaborators

Medipol University

Investigators

  • Principal Investigator: Burcu Dilek, PhD, Trakya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

August 26, 2022

Study Completion (Actual)

March 27, 2023

Study Registration Dates

First Submitted

April 1, 2022

First Submitted That Met QC Criteria

April 15, 2022

First Posted (Actual)

April 21, 2022

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E-10840098-772.02-6568

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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