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Completed

NCT Number: NCT05999539

Comparison of Characteristics Between Faller and Non-faller Transtibial Amputees

Researchers aim to compare demographic characteristics, prosthesis type, functional capacity, and quality of life between faller and non-faller transtibial amputees.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eastern Mediterranean University

Mersin, 33010, Turkey (Türkiye)

About this study

Unilateral transtibial level prosthetic users will be included in this study. After getting the fall history of subjects, those who feel at least one time or more in the last year will be accepted as the faller group. Demographic characteristics, functional capacity, health-related quality of life, and prosthetic types used by amputees will be assessed. The main differences between the faller and non-faller transtibial amputees will be analyzed with the data.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having the ability to walk at least 30-meter independently
  • Using the transtibial prosthesis for at least one year.

Exclusion criteria

  • Multiple limb amputees or prosthetic users
  • Having prosthetic discomfort or stump ulcer

Treatment and study plan

Transtibial prosthesis

Device

A transtibial prosthesis to be used for at least one year.

Primary outcomes

  1. Two-minute walk test

    Time frame: 1 week

    The test to be carried out to find out functional capacity, in a 30-meter-long area will be marked at 3-meter intervals, and the turning points will be determined with an object such as a traffic cone. We will ask the individual to walk the maximum distance in 2 minutes and we will tell them that they can slow down and stop when they get tired. When 2 minutes are completed with a stopwatch, we will ask the individual to stop and record the walking distance in meters.

Secondary outcomes

  1. Functional Reach Test

    Time frame: 1 week

    This test will be used to assess balance. The subjects will be asked to stand sideways next to the wall and wait with the shoulder in 90 degrees flexion, elbow in extension and fist closed without touching the wall with the arm close to the wall. The 3rd metacarpal head will be marked and the patient will be asked to reach as far as they can without taking a step, then the new location of the 3rd metacarpal head will be marked. Scoring will be determined by measuring the difference between the start and end position in centimeters. 3 attempts will be made and the best result will be taken.

  2. Timed Up and Go Test

    Time frame: 1 week

    This test will be used to assess fall risk. A distance of 3 meters will be determined in front of the chair, the individual is asked to get up from the chair and walk the determined distance, and the time elapsed will be recorded with a stopwatch with seconds.

  3. Trinity Amputation and Prosthesis Experiences Scales

    Time frame: 1 week

    This test is used to assess different aspects of amputees' experience of prosthesis use and quality of life. It gives a total score that means better when higher.

Sponsors and collaborators

Lead sponsor

Eastern Mediterranean University

Other

Registry information

Official study title

Comparison of Demography, Functional Capacity, Prosthesis Type and Health-related Quality of Life Between Faller and Non-faller Transtibial Amputees

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 21, 2023
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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