Clinical trial NCT06985329: 3-Dimensional Evaluation of Body Perception
Official title: Evaluation of Neurocognitive Skills, VisuoSpatial Perception and Perspective Perception in Amputees
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: Trakya University
Sponsor class: OTHER
Collaborators: name: Trakya University Scientific Projects and Research Unit
First posted: 2025-05-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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:

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Standardized Mini Mental State Test
timeFrame: 5 minutes
measure: Edinburgh Hand Preference Inventory
timeFrame: 2 minutes
measure: Clock Drawing Test
timeFrame: 5 minutes
measure: Benton Line Orientation Test
timeFrame: 15-20 minutes
measure: CNS Vital Signs Test
timeFrame: 25 minutes
measure: Evaluation of Perspective Perception
timeFrame: 10-15 minutes
measure: Right-left Discrimination Test
timeFrame: 5-10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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:
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citation: 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.
citation: 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.