3-Dimensional Evaluation of Body Perception

NCT06985329 | Not Yet Recruiting

• 1 other identifier: TÜTFGOBAEK 2025/20
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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:

• 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.

Conditions

Body Image; Cognition; Decision Making; Visuospatial/Perceptual Abilities; Neurocognitive Function; Executive Function (Cognition); Amputation

Keywords

Body Image; Cognition; Neuropsychological Test; Amputation; Executive Function; Decision Making; Visuospatial Skills

Outcome Measures

Primary Outcomes (7)

• Standardized Mini Mental State Test

  : 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

  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

  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

  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

  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

  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

  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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Trakya University: lead

Related Publications (6)

• Rosen AB, McGrath ML, Maerlender AL. Males with chronic ankle instability demonstrate deficits in neurocognitive function compared to control and copers. Res Sports Med. 2021 Mar-Apr;29(2):116-128. doi: 10.1080/15438627.2020.1723099. Epub 2020 Jan 29.

  PMID: 31992081 BACKGROUND

• Gualtieri CT, Johnson LG. Reliability and validity of a computerized neurocognitive test battery, CNS Vital Signs. Arch Clin Neuropsychol. 2006 Oct;21(7):623-43. doi: 10.1016/j.acn.2006.05.007. Epub 2006 Oct 2.

  PMID: 17014981 BACKGROUND

• Dilek B, Tavli EY, Yilmaz E, Yaşar E, Ocal T, Çetinkaya O, et al. A Mobile Application Program that Configures Right-Left Hand Recognition According to the Degree of Mental Rotation Difficulty. 2024 Medical Technologies Congress (TIPTEKNO). 2024. IEEE. p.1-3. doi:

  BACKGROUND

• Oldfield RC. The assessment and analysis of handedness: the Edinburgh inventory. Neuropsychologia. 1971 Mar;9(1):97-113. doi: 10.1016/0028-3932(71)90067-4. No abstract available.

  PMID: 5146491 BACKGROUND

• Molloy DW, Alemayehu E, Roberts R. Reliability of a Standardized Mini-Mental State Examination compared with the traditional Mini-Mental State Examination. Am J Psychiatry. 1991 Jan;148(1):102-5. doi: 10.1176/ajp.148.1.102.

  PMID: 1984692 BACKGROUND

• Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

  PMID: 1202204 BACKGROUND

Central Study Contacts

Burcu DILEK, Assoc. Prof.

CONTACT

+90533 027 95 96; ptburcudilek@gmail.com

Elif Yaren TAVLI, Master's Degree Student

CONTACT

+90 531 741 37 08; tavlielifyaren@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 15 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 15, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05