Hand Lateralization by Using EEG Analysis Method in Amputees

NCT ID: NCT05339776

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-03-27

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Body Image

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Hand Lateralization Test

Intervention Type BEHAVIORAL

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.

One of groups: control group

Control group will be matched in terms of age and gender with the amputees group.

Group Type ACTIVE_COMPARATOR

Hand Lateralization Test

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


* between ages 18-65,
* using prosthesis,
* 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:


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medipol University

OTHER

Sponsor Role collaborator

Trakya University

OTHER

Sponsor Role lead

Responsible Party

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Burcu Dilek

PhD, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Burcu Dilek, PhD

Role: PRINCIPAL_INVESTIGATOR

Trakya University

Locations

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Trakya University

Edirne, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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E-10840098-772.02-6568

Identifier Type: -

Identifier Source: org_study_id

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