Clinical trial NCT06293443: Evaluation of Functionality of Amputees According to the Medicare Functional K Classification System
Official title: Evaluation of Functionality of Unilateral Lower Extremity Amputees Grouped According to the Medicare Functional K Classification System-Single Blind Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amputation
Amputation; Traumatic, Leg, Lower
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Unilateral lower extremity amputation,
* Being 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,

Primary outcomes:
measure: Amputee Mobility Scale
timeFrame: 2 weeks
Secondary outcomes:
measure: One Leg Standing Test
timeFrame: 2 weeks
measure: Houghton Scale
timeFrame: 2 weeks
measure: 8-Shape Walking Test
timeFrame: 2 weeks
measure: joint range of motion
timeFrame: 2 weeks
measure: proprioception
timeFrame: 2 weeks
measure: l test
timeFrame: 2 weeks
measure: 10 Meter Walking Test
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medıpol University
Study officials:
affiliation: Medipol University
name: GİZEM BOZTAŞ ELVERİŞLİ
role: STUDY_DIRECTOR
References: