NCT06293443

Evaluation of Functionality of Amputees According to the Medicare Functional K Classification System

Evaluation of Functionality of Unilateral Lower Extremity Amputees Grouped According to the Medicare Functional K Classification System-Single Blind Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Medipol University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of our study is; To evaluate the functionality of lower extremity unilateral amputees, to ensure that the results of the Medicare Functional K Classification System, which provides subjective data for the evaluator, become an objective evaluation method and to determine the functional levels of unilateral amputees; To create an objective data set by applying one-leg standing test, ten meter walking test, L test, figure-8 walking test, joint range of motion, amputee mobility estimator scale, houghton scale and joint position sense evaluation tests.

Detailed description

The study will be carried out at Medicom Orthosis Prosthesis Center and Ortoport Prosthesis Application Center. The study will be conducted in accordance with the principles of human experimentation as defined in the Declaration of Helsinki. For this purpose, amputees who will participate in the study will be given detailed information about the study and will have to sign an informed consent form. 20 unilateral lower extremity amputations will be taken. The inclusion and exclusion criteria of the study are as follows; Inclusion criteria; Unilateral lower extremity amputation, Using a prosthesis, Being literate, Being between the ages of 18-65, Having a healthy stump, Using your current prosthesis in daily living activities, Exclusion criteria; Bilateral lower extremity amputation, Unilateral or bilateral amputation of the upper extremity, Having a cognitive or mental problem, Having serious hearing and vision problems, The individual has an orthopedic disease other than amputation, Having an uncontrolled neurological and systemic systemic disease, SPPS 25.0 (Statistical Package for the Social Sciences) statistical package program will be used to evaluate the data. When the differences between two groups are desired to be evaluated, "Student's t Test" is used if it meets the parametric test prerequisites; If not, the "Mann Whitney-U test" will be used.

Conditions

• Amputation
• Amputation; Traumatic, Leg, Lower

Interventions

Type	Name	Description
OTHER	Lower extremity unilateral amputee	To evaluate the functionality of lower extremity unilateral amputees, to ensure that the results of the Medicare Functional K Classification System, which provides subjective data for the evaluator, become an objective evaluation method and to determine the functional levels of unilateral amputees; To create an objective data set by applying one-leg standing test, Ten meter walking test, L test, figure-8 walking test, joint range of motion, amputee mobility estimator scale, Houghton scale and joint position sense evaluation tests.

Timeline

• Start date: 2024-02-15
• Primary completion: 2024-03-15
• Completion: 2024-04-01
• First posted: 2024-03-05
• Last updated: 2024-03-05

Locations

1 site across 1 country: Turkey (Türkiye)