Evaluation of Functionality of Amputees According to the Medicare

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Amputation
Amputation, Traumatic
Amputation; Traumatic, Leg, Lower

Clinical Trial Details

NCT number	NCT06293443
Study type	Interventional
Source	Medipol University
Contact	TUGBA TANIS
Phone	+905379238206
Email	tugbatnss@gmail.com
Status	Recruiting
Phase	N/A
Start date	February 15, 2024
Completion date	April 1, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms