Amputation of Upper Limb Below ElbowNCT06541379
Effect of Motor Imagery Ability on Functionality and Proprioception in Amputees Using Myoelectric Prostheses"
An observational study of Amputation of Upper Limb Below Elbow and Prosthesis User, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate the motor imagery ability in transradial amputees using myoelectric prosthesis, compare it with the control group and investigate its effect on functionality and proprioception. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation of Upper Limb Below Elbow, Prosthesis User
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 15 Jun 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Being an amputee using a unilateral transradial and myoelectric prosthesis and control group
Who may be able to join
- Amputee group inclusion criteria
- Being an amputee using a unilateral transradial and myoelectric prosthesis
- Having at least 6 months of prosthesis experience
- Having a maximum score of 15 on the Beck Depression Inventory
- Having a minimum score of 26 on the Standardized Mini Mental Test
- Being willing to participate in the study
Show all 12Show fewer
- Control Group inclusion criteria
- Being between the ages of 18-65
- Having a minimum score of 26 on the Standardized Mini Mental Test
- Having signed the Informed Voluntary Consent Form
- Having a maximum score of 15 on the Beck Depression Inventory
- Being literate
Who cannot join
- Amputee group exclusion criteria
- Having another physical problem other than amputation
- Having a diagnosed cognitive disorder
- Not being able to read or write
- Having any neurological, orthopedic, psychological (such as schizophrenia, psychosis) and systemic problems
- Having an unchangeable visual or auditory disability
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Beykoz, 34158
About this study
Official title: Investigation of the Effect of Motor Imagery Ability on Upper Extremity Functionality and Proprioception in Transradial Amputees Using Myoelectric Prostheses
The purpose of this study is to evaluate the motor imagery ability in transradial amputees using myoelectric prosthesis, compare it with the control group and investigate its effect on functionality and proprioception.
Read the detailed description
In the sensory and motor homunculus, the upper extremity, especially the hand, areas cover a larger area. Morphological changes occur in the body in amputees due to upper extremity amputation. In addition, neural restructuring occurs due to the lack of sensory input and visual feedback. These neurophysiological changes experienced in amputees affect the cortical areas of the brain. This situation can also negatively affect motor imagery ability. For this reason, upper extremity prosthesis systems with different control mechanisms have been developed. In one of the developed systems, myoelectric prostheses, since the signals received with electrodes due to muscle contraction provide sensory input to amputees, known that it increases synaptic sprouting in the brain and improves motor imagery ability. There are studies that use motor imagery in stroke, spinal cord injury, Parkinson's disease, postoperative anterior cruciate ligament injuries, cervical and lumbar region pain problems. In addition, it focused on motor imagery after amputation and emphasized that the evidence on whether motor imagery ability is impaired in amputees is not sufficient. In a study, it was found that the use of upper extremity prosthesis increases the hand mental rotation ability and this situation is related to the body integrity of amputees with the use of prosthesis. After investigatorsexamination and screening, to the best of investigators knowledge, no study was found that evaluated the motor imagery ability of transradial amputees using myoelectric controlled prosthesis and examined its effect on functionality. Therefore, the aim of investigators study is to evaluate the motor imagery ability in transradial amputees using myoelectric prosthesis, compare it with the control group and investigate its effect on functionality and proprioception. Transradial amputees using myoelectric prosthesis and the control group (healthy individuals) between the ages of 22-65 will be included in the study. Demographic information of all participants to be included in the study will be recorded with the "Case Assessment Form". Standardized Mini Mental Test (SMMT) to evaluate the cognitive status of individuals, Beck Depression Inventory (BDI) to evaluate depression symptoms, Movement Imagery Questionnaire-3 to evaluate motor imagery ability, Mental Chronometry Test (MKT) measuring motor imagery time, "Orientate" mobile application to evaluate hand mental rotation task performance, Box and Block Test to evaluate gross motor hand skills and functionality, Jebsen Taylor Hand Function Test (JTEFT) to measure upper extremity functions,Disabilities of the Arm Shoulder and Hand (DASH) for upper extremity functional assessment, Modified Functional Reach Test (MFUT) to measure dynamic balance of the trunk, and Joint Position Sense measurement to evaluate proprioceptive sense will be used. All data will be evaluated by statistical analysis methods.
- Being tested
- No intervention
- Keywords
- Imagery, Amputee, Prosthetic, Functional, Myoelectric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Transradial Amputees Using Myoelectric Prosthesis | The Standardized Mini Mental Test (SMMT) will be used to assess the cognitive status of individuals, the Beck Depression Inventory (BDI) to assess depression symptoms, the Movement Imagery Questionnaire-3 to assess motor imagery ability, the Mental Chronometry Test (MKT) to measure motor imagery time, the mobile application called "Orientate" to assess hand mental rotation task performance, the Box and Block Test to assess gross motor dexterity and functionality, the Jebsen Taylor Hand Function Test (JTEFT) to assess fine and gross motor functions of the hand, the Disabilities of the Arm Shoulder and Hand (DASH) for upper extremity functional assessment, the Modified Functional Reach Test (MFUT) to measure the dynamic balance of the trunk and the Joint Position Sense measurement to assess proprioceptive sense. Receives: Other: No intervention | |
| Control Healthy Group | The Standardized Mini Mental Test (SMMT) will be used to assess the cognitive status of individuals, the Beck Depression Inventory (BDI) to assess depression symptoms, the Movement Imagery Questionnaire-3 to assess motor imagery ability, the Mental Chronometry Test (MKT) to measure motor imagery time, the mobile application called "Orientate" to assess hand mental rotation task performance, the Box and Block Test to assess gross motor dexterity and functionality, the Jebsen Taylor Hand Function Test (JTEFT) to assess fine and gross motor functions of the hand, the Disabilities of the Arm Shoulder and Hand (DASH) for upper extremity functional assessment, the Modified Functional Reach Test (MFUT) to measure the dynamic balance of the trunk and the Joint Position Sense measurement to assess proprioceptive sense. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement Imagination Questionnaire-3
In order to determine the imagery ability of all individuals included in the amputee and control groups, the "Movement Imagery Questionnaire-3" developed and validated and validated in Turkish will be used (internal consistency coefficient: 0.87). With the 12 items in this questionnaire, internal visual imagery, external visual imagery and kinesthetic imagery abilities will be assessed through four actions each. The actions will be actively performed by the individuals at the beginning. Then, they were asked to perform these actions as mental tasks. These mental tasks were scored using a seven-point Likert scale (1: very difficult to see, feel; 7: very easy to see, feel). In the calculation of the score, the average score of the four relevant actions will be taken for each of the three sub-dimensions.
Measured: immediately after screening
Secondary outcomes (7)
Orientate Mobile Application
It is used for the purpose of evaluating mental rotation. It is based on the principle of showing individuals hand images from different angles with the application. There are a total of 25 hand images for the test. Participants will be asked to sit comfortably in a chair in front of a table and the mobile application will be opened and the test will be applied. Participants will be asked to decide which of the images is the right and which is the left hand photo as soon as possible. At the end of the test, the application will show the number of correct answers, the number of incorrect answers, the number of missed answers and the time to complete the test. The accuracy rates will also be recorded by comparing the number of correct answers to the total number of images.
Measured: immediately after screening
Box and Block Test
The box and block test is a method used to evaluate gross motor skills and measure functionality. For the test, 150 blocks with dimensions of 2.5 cm and a box divided into two compartments are used. Participants will be asked to take the blocks one by one from the box consisting of two compartments on a table and see how many blocks they can put into the empty compartment placed in the other compartment in 60 seconds, and the results will be noted. In order for the evaluation to be accurate, the process will be repeated three times and the average of the recorded evaluation will be taken.
Measured: immediately after screening
Jebsen Taylor Hand Function Test (JTEFT)
It is a performance-based test developed in 1969 that includes movements in daily life activities. It includes different types of grip and evaluates the speed of individuals in these tasks. The materials for the test are standardized and can be easily accessed in the clinic. Participants will be asked to do 7 different tasks in the test content. These tasks are writing, turning cards, picking up objects, eating, stacking checkers, picking up light wide objects and picking up heavy wide objects. Participants will be asked to do each task separately with both hands. The test score will be calculated by recording the time it takes for participants to complete the tasks.
Measured: immediately after screening
Modified Functional Reach Test (MFUT)
It is a test developed to evaluate the dynamic balance and functionality of the trunk. The distance the trunk can extend forward and sideways without losing balance in a sitting position is measured. The participants will be measured next to a wall with participants ankles, knees, and hips at 90° flexion and participants feet in full contact with the ground. In the relevant position, the arm will be extended parallel to the wall, then extended forward and sideways, and the distance in between will be recorded in cm with the help of a tape measure.
Measured: immediately after screening
Disabilities of the Arm Shoulder and Hand (DASH)
It is a scale that measures the activity and participation limitations of the upper extremity. It is based on the principle of self-assessment of the results. In 2006, the validity and reliability study of the survey in Turkish was conducted. There are 11 questions in the survey. It aims to question the difficulties that individuals have during participants daily living activities. The answers are scored from good to bad on a Likert scale, with each answer being scored from 1 to 5. The survey has options such as 1 = no difficulty, 2 = mild difficulty, 3 = moderate difficulty, 4 = extreme difficulty, and 5 = unable to do at all.
Measured: immediately after screening
Joint Position Sense Measurement
Joint position sense is evaluated with the aim of measuring the ability of a certain joint angle to be repeated in an individual. This measurement can be applied passively-actively or with eyes closed-open. This test reveals the acuity of defining a certain angle in joints. Considering the amputation level of transradial amputees included in investigators study, shoulder and elbow joint position sense of all participants will be measured.
Measured: immediately after screening
Mental Chronometry Test
It is known as another method that can be used to evaluate motor imagery ability. Mental chronometry is based on the principle of comparing the time it takes to perform a movement with the time it takes to mentally image the same movement. This test provides more objective results than survey applications. The Mental Chronometry test will be evaluated in investigators study with the help of the Box and Block Test. Participants will be asked to imagine this task after performing the box block test performance. The time required to collect 15 blocks will be recorded, unlike the normal procedure of the box block test. Purpose is evaluate mental chronometry ability rather than gross manual dexterity.
Measured: immediately after screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Jun 2025
- Primary completion1 Apr 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amputation of Upper Limb Below ElbowStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Yazgan, Medipol University
- Investigators
- Ayşe Yazgan, Study director, https://www.medipol.edu.tr/
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541379
- Sponsor's protocol ID
- MedipolU-OP-AY-01
- Status last verified
- Jul 2026
- First submitted
- 1 Aug 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saimpont A, Malouin F, Durand A, Mercier C, di Rienzo F, Saruco E, Collet C, Guillot A, Jackson PL. The effects of body position and actual execution on motor imagery of locomotor tasks in people with a lower-limb amputation. Sci Rep. 2021 Jul 2;11(1):13788. doi: 10.1038/s41598-021-93240-6.
PubMed 34215827
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Motor Imagery Ability on Upper Extremity Functionality and Proprioception in Transradial Amputees Using Myoelectric Prostheses
- ClinicalTrials.gov ID
- NCT06541379
- Acronym / sponsor ID
- MedipolU-OP-AY-01
- Keywords
- Imagery, Amputee, Prosthetic, Functional, Myoelectric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 7 Aug 2024 (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 purpose of this study is to evaluate the motor imagery ability in transradial amputees using myoelectric prosthesis, compare it with the control group and investigate its effect on functionality and proprioception.
Detailed description
In the sensory and motor homunculus, the upper extremity, especially the hand, areas cover a larger area. Morphological changes occur in the body in amputees due to upper extremity amputation. In addition, neural restructuring occurs due to the lack of sensory input and visual feedback. These neurophysiological changes experienced in amputees affect the cortical areas of the brain. This situation can also negatively affect motor imagery ability. For this reason, upper extremity prosthesis systems with different control mechanisms have been developed. In one of the developed systems, myoelectric prostheses, since the signals received with electrodes due to muscle contraction provide sensory input to amputees, known that it increases synaptic sprouting in the brain and improves motor imagery ability. There are studies that use motor imagery in stroke, spinal cord injury, Parkinson's disease, postoperative anterior cruciate ligament injuries, cervical and lumbar region pain problems. In addition, it focused on motor imagery after amputation and emphasized that the evidence on whether motor imagery ability is impaired in amputees is not sufficient. In a study, it was found that the use of upper extremity prosthesis increases the hand mental rotation ability and this situation is related to the body integrity of amputees with the use of prosthesis. After investigatorsexamination and screening, to the best of investigators knowledge, no study was found that evaluated the motor imagery ability of transradial amputees using myoelectric controlled prosthesis and examined its effect on functionality. Therefore, the aim of investigators study is to evaluate the motor imagery ability in transradial amputees using myoelectric prosthesis, compare it with the control group and investigate its effect on functionality and proprioception. Transradial amputees using myoelectric prosthesis and the control group (healthy individuals) between the ages of 22-65 will be included in the study. Demographic information of all participants to be included in the study will be recorded with the "Case Assessment Form". Standardized Mini Mental Test (SMMT) to evaluate the cognitive status of individuals, Beck Depression Inventory (BDI) to evaluate depression symptoms, Movement Imagery Questionnaire-3 to evaluate motor imagery ability, Mental Chronometry Test (MKT) measuring motor imagery time, "Orientate" mobile application to evaluate hand mental rotation task performance, Box and Block Test to evaluate gross motor hand skills and functionality, Jebsen Taylor Hand Function Test (JTEFT) to measure upper extremity functions,Disabilities of the Arm Shoulder and Hand (DASH) for upper extremity functional assessment, Modified Functional Reach Test (MFUT) to measure dynamic balance of the trunk, and Joint Position Sense measurement to evaluate proprioceptive sense will be used. All data will be evaluated by statistical analysis methods.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transradial Amputees Using Myoelectric Prosthesis | – | Other: No interventionThe Standardized Mini Mental Test (SMMT) will be used to assess the cognitive status of individuals, the Beck Depression Inventory (BDI) to assess depression symptoms, the Movement Imagery Questionnaire-3 to assess motor imagery ability, the Mental Chronometry Test (MKT) to measure motor imagery time, the mobile application called "Orientate" to assess hand mental rotation task performance, the Box and Block Test to assess gross motor dexterity and functionality, the Jebsen Taylor Hand Function Test (JTEFT) to assess fine and gross motor functions of the hand, the Disabilities of the Arm Shoulder and Hand (DASH) for upper extremity functional assessment, the Modified Functional Reach Test (MFUT) to measure the dynamic balance of the trunk and the Joint Position Sense measurement to assess proprioceptive sense. |
| Control Healthy Group | – | Other: No interventionThe Standardized Mini Mental Test (SMMT) will be used to assess the cognitive status of individuals, the Beck Depression Inventory (BDI) to assess depression symptoms, the Movement Imagery Questionnaire-3 to assess motor imagery ability, the Mental Chronometry Test (MKT) to measure motor imagery time, the mobile application called "Orientate" to assess hand mental rotation task performance, the Box and Block Test to assess gross motor dexterity and functionality, the Jebsen Taylor Hand Function Test (JTEFT) to assess fine and gross motor functions of the hand, the Disabilities of the Arm Shoulder and Hand (DASH) for upper extremity functional assessment, the Modified Functional Reach Test (MFUT) to measure the dynamic balance of the trunk and the Joint Position Sense measurement to assess proprioceptive sense. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Being an amputee using a unilateral transradial and myoelectric prosthesis and control group
Key inclusion criteria (12 listed)
- Amputee group inclusion criteria
- Being an amputee using a unilateral transradial and myoelectric prosthesis
- Having at least 6 months of prosthesis experience
- Having a maximum score of 15 on the Beck Depression Inventory
- Having a minimum score of 26 on the Standardized Mini Mental Test
Key exclusion criteria (6 listed)
- Amputee group exclusion criteria
- Having another physical problem other than amputation
- Having a diagnosed cognitive disorder
- Not being able to read or write
- Having any neurological, orthopedic, psychological (such as schizophrenia, psychosis) and systemic problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | Control Healthy Group, Transradial Amputees Using Myoelectric Prosthesis |
Primary outcome
Movement Imagination Questionnaire-3
Time frame: immediately after screening
In order to determine the imagery ability of all individuals included in the amputee and control groups, the "Movement Imagery Questionnaire-3" developed and validated and validated in Turkish will be used (internal consistency coefficient: 0.87). With the 12 items in this questionnaire, internal visual imagery, external visual imagery and kinesthetic imagery abilities will be assessed through four actions each. The actions will be actively performed by the individuals at the beginning. Then, they were asked to perform these actions as mental tasks. These mental tasks were scored using a seven-point Likert scale (1: very difficult to see, feel; 7: very easy to see, feel). In the calculation of the score, the average score of the four relevant actions will be taken for each of the three sub-dimensions.
7 secondary outcomes
Orientate Mobile Application
Time frame: immediately after screening
Box and Block Test
Time frame: immediately after screening
Jebsen Taylor Hand Function Test (JTEFT)
Time frame: immediately after screening
Modified Functional Reach Test (MFUT)
Time frame: immediately after screening
Disabilities of the Arm Shoulder and Hand (DASH)
Time frame: immediately after screening
Joint Position Sense Measurement
Time frame: immediately after screening
Mental Chronometry Test
Time frame: immediately after screening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Results publication: PubMed 34215827Saimpont A, Malouin F, Durand A, Mercier C, di Rienzo F, Saruco E, Collet C, Guillot A, Jackson PL. The effects of body position and actual execution on motor imagery of locomotor tasks in people with a lower-limb amputation. Sci Rep. 2021 Jul 2;11(1):13788. doi: 10.1038/s41598-021-93240-6.
- Reference Article LinkLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Ayşe Yazgan study director
https://www.medipol.edu.tr/
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation of Upper Limb Below Elbow and Prosthesis User, run by Medipol University at 1 site in Turkey (Türkiye).
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 12 inclusion and 6 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: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement Imagination Questionnaire-3 (time frame: immediately after screening). 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 NCT06541379, which also lists 1 linked publication.
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 14 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.