3-Dimensional Evaluation of Body Perception

May 14, 2025 updated by: Burcu Dilek, Trakya University

Evaluation of Neurocognitive Skills, VisuoSpatial Perception and Perspective Perception in Amputees

The goal of this observational study is to evaluate the changing body perception of amputees aged 18-65 years using prostheses through different personal perspectives of the right-left distinction. In addition, we aimed to examine the relationship between possible changes in body perception and visual spatial perception and neurocognitive performances. The main questions that this study aimed to answer are as follows:

  1. Is there a difference between the amputee group and the control group in terms of parameters related to body perception?
  2. Is there a difference between the amputee group and the control group in terms of neurocognitive skills?
  3. Is there any difference between the amputee group and the control group in terms of visual spatial perception abilities?

To examine whether changes in body perception in amputees affect neurocognitive performance, visuospatial perception and perspective perception and the relationship between them will be compared with a healthy control group.

The assessments to be applied to both groups can be summarised as follows:

  • Demographic information such as age, gender, and education level will be recorded.
  • Mini-mental state test will be used to assess the cognitive level.
  • Edinburgh Handedness Scale will be used to determine the dominant side.
  • Right-left discrimination and personal perspective perception will be assessed using a desktop programme.
  • The clock drawing test and Benton line orientation test will be used to visual spatial perception.
  • A computer based program called The Central Nervous System (CNS) Vital Signs Neurocognitive Test Battery will be used to asesses neurocognitive abilities.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

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

Study Contact

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

For the amputee group, orthotic prosthesis clinics will be contacted in various cities. In order to increase the number of participants, participants will be recruited from other cities outside Edirne. Priority will be given to cities with large populations, such as Istanbul and Ankara.

Healthy volunteers will be collected within the city of Edirne.

Description

Inclusion criteria for the amputee group:

  • Acquired amputees
  • Aged 18-65 years
  • Using a prosthesis for at least six months
  • At least a primary school graduate
  • Individuals who can adapt to prolonged, attention-demanding activities will be included.
  • Standardised Mini Mental State Examination score of >24.

Following the recruitment of the amputee group, a healthy control group will be recruited to match it in terms of age, gender and educational status.

Inclusion criteria for the healthy control group:

  • Age range: 18-65 years
  • At least a primary school graduate
  • Individuals who can adapt to prolonged, attention-demanding activities will be included.
  • Standardised Mini Mental State Examination score of >24.

Exclusion criteria for the amputee group:

  • Individuals with congenital amputation
  • Those with phantom limb pain and/or sensation
  • Those with an open wound on the stump
  • Bilateral amputation
  • Any neurological or psychiatric diagnosis
  • Those using sedative medication and/or its derivatives
  • Have vision and related problems
  • Individuals who are illiterate
  • Individuals participating in treatments targeting body representation (e.g. imagery-based treatments or progressive motor visualisation) will not be included in the study.

Exclusion criteria for the Healthy Control Group:

  • Having any neurological or psychiatric diagnosis
  • Using sedative medication and/or its derivatives
  • People with vision and related problems
  • Illiterate individuals will not be included in the study.

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

Cohorts and Interventions

Group / Cohort
Amputee Group
Amputees between the ages of 18-65 who use prostheses will be included in the study. Participants who meet the inclusion criteria will be included in this group.
Control Group
A healthy control group will be recruited. This group will be matched in terms of age, gender, and educational status to the amputee group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standardized Mini Mental State Test
Time Frame: 5 minutes
: It is one of the tests used to assess cognitive impairment. It consists of 5 main topics including various areas of cognitive functioning such as time and space orientation, stored memory, attention and calculation, short-term memory, language (writing sentences, drawing shapes, reading and applying written instructions, etc.). It is aimed to minimize distraction by applying in a quiet environment where the participants are comfortable.
5 minutes
Edinburgh Hand Preference Inventory
Time Frame: 2 minutes
It is a 10-item scale that assesses participants' dominant hand preference. The researcher directs the items to the participants and the participants are expected to answer "right", "partly right", "left", "partly left" or "I use both".
2 minutes
Clock Drawing Test
Time Frame: 5 minutes
It is a test that assesses visual-motor functions, planning, sequencing, abstract thinking skills and visual spatial perception. Participants are given a 10 cm hollow circle on paper. Participants are asked to place all the numbers of the clock inside the circle and draw the hour and minute hands so that the hour and minute hands point to 10 minutes past 11.
5 minutes
Benton Line Orientation Test
Time Frame: 15-20 minutes
It is a test used to measure the orientation component of visual spatial abilities. It consists of 5 practice tests and 30 test items. Participants who get at least 2 of the 5 practice tests correct will be directed to move on to the 30 test items. In this test, participants are asked to: Perceive which 2 lines in the lower part of the test item are in equal angle and direction with which two of the 11 lines in the upper part of the test item and mark the 2 numbers with the correct option.
15-20 minutes
CNS Vital Signs Test
Time Frame: 25 minutes
It is a computer-based neurocognitive test battery used to assess participants' neurocognitive performance. It consists of 7 sub-headings in total and evaluates 12 neurocognitive domains of the participants. The 7 sub-headings are as follows; verbal memory, visual memory, finger tapping, symbol-number coding, stroop test, attention orientation, continuous performance tests. The tests are conducted on a computer. The participant is expected to complete the tests by following the rules and instructions specified in each test.
25 minutes
Evaluation of Perspective Perception
Time Frame: 10-15 minutes
A virtual reality supported desktop application developed with a software program will be used to evaluate perspective perception. Participants are asked to stand in front of the computer positioned on the desktop. During the test, the participants will see an avatar animation in different angles (0-45-90-135-180-225-270-315) and perspectives (eye level, above eye level, below eye level, from the top and from the bottom) and they will be asked to adapt the body of the avatar they see to their own body and make the same limb movement (shoulder abduction) that the avatar makes. At the end of the test, movement angle values and reaction times of the participants will be recorded.
10-15 minutes
Right-left Discrimination Test
Time Frame: 5-10 minutes
As an alternative to Recognise, the paradigm developed with the "e-prime" software program will be used to evaluate the right-left distinction. Participants will be presented with hand visuals with mental rotation categorized from easy to difficult. Test categories will be applied in a randomized order. In each set (easy-moderate-difficult), 30 images will be presented in different postures and randomly right and left. The participants will answer the presented images by pressing the "right" or "left" buttons on the screen. Participants will be asked to complete the test as soon as they can. At the end of the test, participants' completion times, reaction times for each level and side, and success rates will be recorded.
5-10 minutes

Collaborators and Investigators

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

Sponsor

Trakya University

Collaborators

Trakya University Scientific Projects and Research Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

June 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

May 14, 2025

First Submitted That Met QC Criteria

May 14, 2025

First Posted (Actual)

May 22, 2025

Study Record Updates

Last Update Posted (Actual)

May 22, 2025

Last Update Submitted That Met QC Criteria

May 14, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TÜTFGOBAEK 2025/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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