Comparison of Characteristics Between Faller and Non-faller Transtibial Amputees

Completed

• Conditions: Amputation; Ambulation Difficulty; Fall; Prosthesis User; Quality of Life
• Interventions: Device: Transtibial prosthesis

• Registration Number: NCT05999539
• Lead Sponsor: Eastern Mediterranean University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-08-12
• Study First Submitted QC: 2023-08-12
• Study First Posted: 2023-08-21
• Study Start: 2023-08-25
• Status Verified: 2023-12
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2023-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Faller transtibial prosthetic users	Transtibial prosthesis	Transtibial prosthetic users who fell at least once in the last year.
Non-faller transtibial prosthetic users	Transtibial prosthesis	Transtibial prosthetic users who have no fall history.

Primary Outcome Measures

Name	Time	Method
Two-minute walk test	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 Outcome Measures

Name	Time	Method
Timed Up and Go Test	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.
Trinity Amputation and Prosthesis Experiences Scales	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.
Functional Reach Test	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.

Trial Locations

Locations (1)

Eastern Mediterranean University; 🇹🇷 Mersin, Turkey