Clinical trial NCT06541379: Effect of Motor Imagery Ability on Functionality and Proprioception in Amputees Using Myoelectric Prostheses"
Official title: Investigation of the Effect of Motor Imagery Ability on Upper Extremity Functionality and Proprioception in Transradial Amputees Using Myoelectric Prostheses
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Amputation of Upper Limb Below Elbow
Prosthesis User
Keywords: Imagery
Amputee
Prosthetic
Functional
Myoelectric
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Being an amputee using a unilateral transradial and myoelectric prosthesis and control group

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

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

Exclusion Criteria:

Amputee group exclusion criteria

* Having another physical problem other than amputation
* Having a diagnosed cognitive disorder
* Not being able to read or write

Exclusion criteria for the control group from the study

* Having any neurological, orthopedic, psychological (such as schizophrenia, psychosis) and systemic problems
* Having an unchangeable visual or auditory disability

Primary outcomes:
measure: Movement Imagination Questionnaire-3
timeFrame: immediately after screening
measure: Mental Chronometry Test
timeFrame: immediately after screening
Secondary outcomes:
measure: Orientate Mobile Application
timeFrame: immediately after screening
measure: Box and Block Test
timeFrame: immediately after screening
measure: Jebsen Taylor Hand Function Test (JTEFT)
timeFrame: immediately after screening
measure: Modified Functional Reach Test (MFUT)
timeFrame: immediately after screening
measure: Disabilities of the Arm Shoulder and Hand (DASH)
timeFrame: immediately after screening
measure: Joint Position Sense Measurement
timeFrame: immediately after screening
Other outcomes:
measure: Beck Depression Inventory
timeFrame: immediately after screening
measure: Standardized Mini Mental Test (SMMT)
timeFrame: immediately after screening
Locations:
Study officials:
affiliation: https://www.medipol.edu.tr/
name: Ayşe Yazgan
role: STUDY_DIRECTOR
References:
citation: 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.