Comparison of Characteristics Between Faller and Non-faller Transtibial Amputees

Comparison of Demography, Functional Capacity, Prosthesis Type and Health-related Quality of Life 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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Amputation; Fall; Prosthesis User; Ambulation Difficulty
• Intervention / Treatment: Device: Transtibial prosthesis

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 Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Turkey
  • Mersin, Turkey, 33010
    • Eastern Mediterranean University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The population will be the transtibial prosthetic users recorded in outpatient clinics working on amputee rehabilitation.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Faller transtibial prosthetic users; Transtibial prosthetic users who fell at least once in the last year.	Device: Transtibial prosthesis; A transtibial prosthesis to be used for at least one year.
Non-faller transtibial prosthetic users; Transtibial prosthetic users who have no fall history.	Device: Transtibial prosthesis; A transtibial prosthesis to be used for at least one year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Eastern Mediterranean University

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2023
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: August 12, 2023
• First Submitted That Met QC Criteria: August 12, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mobility Limitation
• Other Study ID Numbers: ETK00-2023-0130

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data of participants will not be shared individually because of health policy. Results will be shared as an overall data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No