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

NCT ID: NCT07032233

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2026-09-30

Brief Summary

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.

Detailed 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.

Conditions

Transfemoral Amputation

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

transfemoral amputation

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

OTHER

Sponsor Role: collaborator

Hacettepe University

OTHER

Sponsor Role: collaborator

Ceren Kuzu

OTHER

Sponsor Role: lead

Responsible Party

Ceren Kuzu

PhD Candidate, Physiotherapist

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Ceren Kuzu, MSc, Physical Therapist

Role: CONTACT

ce.kuzu@gmail.com

+905067027093

Semra Topuz, Prof, Physical Therapist

Role: CONTACT

fztsemra@yahoo.com

+905055800590

Other Identifiers

FTREK25/31

Identifier Type: -

Identifier Source: org_study_id