Sagittal Knee Kinematics of Transtibial Amputee with Running Blade

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

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.

Study Overview

• Status: Completed
• Conditions: Amputation; Prosthesis User

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• Turkey
  • Etlik Keçiören
    • Ankara, Etlik Keçiören, Turkey, 06010
      • University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Unilateral transtibial amputee at K4 functional level

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Daily-Use Prosthesis (DUP); Participants are going video recorded in the sagittal plane, to convert knee flexion motion into angles for the amputated and intact knee and to make measurements using the software's virtual goniometer. The recording will be taken during walking at self-selected walking speed with DUP.
Running-Specific Prosthesis (RSP); Participants are going video recorded in the sagittal plane, to convert knee flexion motion into angles for the amputated and intact knee and to make measurements using the software's virtual goniometer. The recording will be taken during slow-running (heel-strike jogging) with RSP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sagital Knee Kinematics of intact and residual knee with Daily-Use Prosthesis (DUP)	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.	Baseline
Sagital Knee Kinematics of intact and residual knee with Running-Specific Prosthesis (RSP)	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.	Same day as baseline; 10 minutes after RSP integrated to prosthesis.

Collaborators and Investigators

• Sponsor: Baskent University
• Collaborators: Universtiy of Health Sciences - Gülhane Faculty of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2024
• Primary Completion (Actual): October 5, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: September 2, 2024
• First Submitted That Met QC Criteria: September 5, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 23, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: knee; amputee; symmetry; running; running-specific prosthesis
• Other Study ID Numbers: 2024/369

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No