Comparison of Characteristics Between Faller and Non-faller Transtibial Amputees

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05999539
• Other study ID #: ETK00-2023-0130
• Status: Completed
• Start date: August 25, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: December 2023
• Source: Eastern Mediterranean University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ambulation Difficulty
• Amputation
• Fall
• Mobility Limitation
• Prosthesis User
• Quality of Life

Intervention

Device:
• Transtibial prosthesis
A transtibial prosthesis to be used for at least one year.

Locations

Country	Name	City	State
Turkey	Eastern Mediterranean University	Mersin

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Two-minute walk test	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.	1 week
Secondary	Functional Reach Test	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.	1 week
Secondary	Timed Up and Go Test	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.	1 week
Secondary	Trinity Amputation and Prosthesis Experiences Scales	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.	1 week