Body ImageNCT06985329
3-Dimensional Evaluation of Body Perception
An observational study of Body Image and Cognition, run by Trakya University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Image, Cognition, Decision Making
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to 15 Jun 2026
- How long will I take part?
- 15 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
- Is there a difference between the amputee group and the control group in terms of parameters related to body perception?
- Is there a difference between the amputee group and the control group in terms of neurocognitive skills?
- Is there any difference between the amputee group and the control group in terms of visual spatial perception abilities?
Read more
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.
- Conditions
- Body Image, Cognition, Decision Making, Visuospatial/Perceptual Abilities, Neurocognitive Function, Executive Function (Cognition)
- Keywords
- Body Image, Cognition, Neuropsychological Test, Amputation, Executive Function, Decision Making, Visuospatial Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study startJun 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Body ImageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Dilek, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985329
- Sponsor's protocol ID
- TÜTFGOBAEK 2025/20
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31992081Gualtieri 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.
PubMed 17014981Dilek 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:
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.
PubMed 5146491Molloy 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.
PubMed 1984692Folstein 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.
PubMed 1202204
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Neurocognitive Skills, VisuoSpatial Perception and Perspective Perception in Amputees
- ClinicalTrials.gov ID
- NCT06985329
- Acronym / sponsor ID
- TÜTFGOBAEK 2025/20
- Conditions
- Body Image, Cognition, Decision Making, Visuospatial/Perceptual Abilities, Neurocognitive Function, Executive Function (Cognition)
- Keywords
- Body Image, Cognition, Neuropsychological Test, Amputation, Executive Function, Decision Making, Visuospatial Skills
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is there a difference between the amputee group and the control group in terms of parameters related to body perception?
- Is there a difference between the amputee group and the control group in terms of neurocognitive skills?
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 15 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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".
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Background: PubMed 31992081Rosen 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.
- Background: PubMed 17014981Gualtieri 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.
- BackgroundDilek 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: PubMed 5146491Oldfield 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.
- Background: PubMed 1984692Molloy 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.
- Background: PubMed 1202204Folstein 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Image and Cognition, run by Trakya University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Burcu DILEK, Assoc. Prof. (+90533 027 95 96, ptburcudilek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized Mini Mental State Test (time frame: 5 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06985329, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.