Assessment of Strength, Balance, and Function in Above-Knee Amputees in Relation to Residual Limb Length

Ceren Kuzu

Status: Not yet enrolling

Conditions: Transfemoral Amputation

Study type: Observational

Funder types: Other

Identifiers

NCT07032233

FTREK25/31

Details and patient eligibility

About

The goal of this observational study is to learn how muscle strength, balance, and functional ability are affected in people with above-knee (transfemoral) amputations. The main questions it aims to answer are:

How does the length of the lost part of the leg, compared to the intact leg, affect muscle strength, balance, and functional capacity?

Is muscle strength at specific lower limb joints related to balance and performance ?

Participants will:

Have muscle strength measured at all intact lower limb joints using an isokinetic dynamometer

Complete balance assessments using force platform technology that measures weight distribution and evaluates both static and dynamic balance

Perform a six-minute walk test to evaluate endurance and functional capacity

The study will help improve understanding of how limb length and joint-specific muscle strength impact mobility, supporting the development of better rehabilitation programs for amputees.

Full description

This study is a cross-sectional observational study designed to assess lower extremity muscle strength, balance, and functional capacity in individuals with unilateral transfemoral amputation. The primary aim is to examine how the length of the lost part of the limb, in relation to the intact limb, correlates with these physical performance parameters. This study does not involve any intervention or follow-up over time. All data will be collected at one time point. Therefore, although the registry requires a study model selection, the study design does not align with standard cohort or case-control models. For this reason, the "Other" option was selected as the most appropriate observational study model.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Individuals will be included in the study if they:

Are between 18 and 50 years of age

Are literate

Have unilateral transfemoral amputation

Have no cardiovascular, orthopedic, cognitive, or neurological conditions that could negatively affect balance, gait, or muscle strength

Are able to ambulate independently with a prosthesis

Have been walking for at least 6 months

Voluntarily agree to participate in the study

Exclusion criteria

Participants will be excluded from the study if:

They develop complications such as pain (rated 3 or higher on the Visual Analog Scale) or stump irritation during the course of the study

Their residual limb length is less than 25 cm from the greater trochanter, which exceeds the limitations of the isokinetic dynamometer attachments used in the study

They voluntarily withdraw from the study - in such cases, their data will be removed from the records

Trial design

15 participants in 1 patient group

transfemoral amputation

Description:

Adults with unilateral transfemoral amputation who indepently ambulates with a prosthetic limb.