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

NCT06293443 | Recruiting

• 1 other identifier: IMU-OP-TT-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation; Amputation; Traumatic, Leg, Lower

Outcome Measures

Primary Outcomes (1)

• Amputee Mobility Scale

  It is a 21-item scale that evaluates static and dynamic balance. It is also used to predict the amputee's potential ambulation level. It is also a scale used to evaluate function during or after rehabilitation. Questions include sitting balance, transfers, standing balance, walking, stairs, assistive device use. Scoring is made between 0-47.

  2 weeks

Secondary Outcomes (7)

• One Leg Standing Test

  2 weeks

• Houghton Scale

  2 weeks

• 8-Shape Walking Test

  2 weeks

• joint range of motion

  2 weeks

• proprioception

  2 weeks

Study Arms (1)

Lower extremity unilateral amputee

OTHER

Unilateral transtibial and unilateral transfemoral amputees were evaluated in the study. Criteria for autees to participate in the study; Being a unilateral lower extremity amputee, using a prosthesis, being literate, being between the ages of 18-65, having a healthy stump, and using their current prosthesis in daily life activities. Individuals who had knee disarticulation amputation and individuals who had hip disarticulation amputation were not included in the study.

Other: Lower extremity unilateral amputee

Interventions

Lower extremity unilateral amputee OTHER

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.

Lower extremity unilateral amputee

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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,

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medıpol University

Istanbul, Turkey (Türkiye)

RECRUITING

Study Officials

• GİZEM BOZTAŞ ELVERİŞLİ

  Medipol University

  STUDY DIRECTOR

Central Study Contacts

TUĞBA TANIŞ

CONTACT

+905379238206; tugbatnss@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: participants underwent functional testing at clinical centers
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start: February 15, 2024
• Primary Completion: March 15, 2024
• Study Completion: April 1, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)