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NCT Number: NCT06985329

3-Dimensional Evaluation of Body Perception

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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".

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Burcu DILEK, Assoc. Prof.

CONTACT

[email protected]

+90533 027 95 96

Elif Yaren TAVLI, Master's Degree Student

CONTACT

[email protected]

+90 531 741 37 08

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 22, 2025
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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