Comparison of Characteristics Between Faller and Non-faller Transtibial Amputees

NCT05999539 | Completed

• 1 other identifier: ETK00-2023-0130
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Amputation; Fall; Ambulation Difficulty; Quality of Life; Prosthesis User

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Functional Reach Test

  1 week

• Timed Up and Go Test

  1 week

• Trinity Amputation and Prosthesis Experiences Scales

  1 week

Study Arms (2)

Faller transtibial prosthetic users

Transtibial prosthetic users who fell at least once in the last year.

Device: Transtibial prosthesis

Non-faller transtibial prosthetic users

Transtibial prosthetic users who have no fall history.

Device: Transtibial prosthesis

Interventions

Transtibial prosthesis DEVICE

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

Faller transtibial prosthetic users; Non-faller transtibial prosthetic users

Eligibility Criteria

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

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Eastern Mediterranean University

Mersin, 33010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: August 12, 2023
• First Posted: August 21, 2023
• Study Start: August 25, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)