Sagittal Knee Kinematics of Transtibial Amputee with Running Blade

Introduction: People with transtibial amputation often suffer musculoskeletal deformities in the form of knee osteoarthritis or osteophytosis due to asymmetric movement patterns and often complain of associated symptoms. Therefore, this study aims to evaluate the sagittal kinematics of the intact and residual knee in the use of Running-Specific Prostheses (RSP), which are increasing in popularity and use among amputees.

Materials and Methods: Participants will be video recorded in the sagittal plane to convert knee flexion motion into angles for the amputee and intact knee and to make measurements using the software's virtual goniometer. Recordings will be taken under the following two conditions: 1) walking at a self-selected walking speed with a Daily Use Prosthesis (DUP); 2) Slow running with RSP. The peak flexion during the swing phase and the initial flexion during the first contact of the stance phase will be recorded as angles in both conditions.

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Key information

Conditions

Amputation Prosthesis User

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Health Sciences

Ankara, Etlik Keçiören, 06010, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

body mass index below 30 kg/m2,
Having unilateral transtibial amputation,
Being at K4 functional level,
Having an existing running blade,
Being able to use RSP integrating it into their DUP,
Having no self-reported problems with the residual limb or prosthesis, pain or skin lesions,
Being active recreational runners (at least once a week) for at least 1 and up to 3 months without injury.

Exclusion criteria

Having a history of knee surgery or contracture in the intact/amputee knee.

Treatment and study plan

Primary outcomes

Sagital Knee Kinematics of intact and residual knee with Daily-Use Prosthesis (DUP)

Time frame: Baseline

In the sagittal plan, knee flexion motion for the amputated and intact knee will be recorded during walking at self-selected walking speed with Daily-Use Prosthesis (DUP). The peak flexion during swing phase and the initial flexion during initial contact of the stance phase were recorded as angle.
Sagital Knee Kinematics of intact and residual knee with Running-Specific Prosthesis (RSP)

Time frame: Same day as baseline; 10 minutes after RSP integrated to prosthesis.

In the sagittal plan, knee flexion motion for the amputated and intact knee will be recorded during slow-running (jogging) with Running-Specific Prosthesis (RSP). The peak flexion during swing phase and the initial flexion during initial contact of the stance phase were recorded as angle.

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Collaborators

Gulhane School of Medicine

Registry information

Official study title

Symmetry in Sagittal Knee Kinematics of Transtibial Amputee: Daily-Use Prosthesis Vs Running-Specific Prosthesis

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Sep 19, 2024
Registry last updated: Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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