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Comparison of Characteristics Between Faller and Non-faller Transtibial Amputees

NCT ID: NCT05999539

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-25

Study Completion Date

2023-12-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Amputation Fall Ambulation Difficulty Quality of Life Prosthesis User

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Faller transtibial prosthetic users

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

Transtibial prosthesis

Intervention Type DEVICE

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

Non-faller transtibial prosthetic users

Transtibial prosthetic users who have no fall history.

Transtibial prosthesis

Intervention Type DEVICE

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

Interventions

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Transtibial prosthesis

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eastern Mediterranean University

OTHER

Sponsor Role lead

Responsible Party

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Yasin YURT

Assoc. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eastern Mediterranean University

Mersin, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ETK00-2023-0130

Identifier Type: -

Identifier Source: org_study_id