Sagittal Knee Kinematics of Transtibial Amputee with Running Blade

NCT06586762 | Completed

• 1 other identifier: 2024/369
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amputation; Prosthesis User

Keywords

amputee; symmetry; knee; running; running-specific prosthesis

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Unilateral transtibial amputee at K4 functional level

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Baskent University: lead
• Gulhane School of Medicine: collaborator

Study Sites (1)

University of Health Sciences

Ankara, Etlik Keçiören, 06010, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 19, 2024
• Study Start: September 5, 2024
• Primary Completion: October 5, 2024
• Study Completion: October 30, 2024
• Last Updated: February 25, 2025

Record last verified: 2024-09

Locations

TU (1)