NCT05339776

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

1.5 years

First QC Date

April 1, 2022

Last Update Submit

September 19, 2023

Conditions

Body Image

Keywords

EEGmental rotationhand lateralizationhand recognitionamputeesbody schema

Outcome Measures

Primary Outcomes (1)

  • Electroencephalogram (EEG) frequency bands: alpha, theta, beta, gamma

    Changes in power spectrum and phase locking

    Before and after the hand lateralization test: 10-14 days

Secondary Outcomes (2)

  • Reaction time to decide whether the hand is right or left

    Before and after the hand lateralization test: 10-14 days

  • Accuracy proportion of given answers regarding hand lateralization

    Before and after the hand lateralization test: 10-14 days

Study Arms (2)

One of groups: amputees group

ACTIVE COMPARATOR

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

One of groups: control group

ACTIVE COMPARATOR

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

Behavioral: Hand Lateralization Test

Interventions

Hand Lateralization TestBEHAVIORAL

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: amputees groupOne of groups: control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • between ages 18-65,
  • using prosthesis,
  • A score of 21 or higher on the Montreal Cognitive Assessment Test
  • 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,
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University

Edirne, Turkey (Türkiye)

Location

Study Officials

  • Burcu Dilek, PhD

    Trakya University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Principal Investigator

Study Record Dates

First Submitted

April 1, 2022

First Posted

April 21, 2022

Study Start

March 1, 2021

Primary Completion

August 26, 2022

Study Completion

March 27, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)