NCT06849934

Brief Summary

The primary aim of this study was to find the reliability of Kinovea software in measuring parameters associated with sagittal plane knee kinematics during gait in transtibial amputees. The secondary objective was to calculate the absolute reliability by calculating the Standard Error of Measurement (SEM), SEM% and Minimal Detectable Change at 95% confidence interval (MDC95). The SEM value represents the extent to which a score changes during the repetition of the measurement. The MDC is the minimum change in the measurement that is considered a true change in the measured activity that is not due to error.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

February 27, 2025

Status Verified

September 1, 2024

Enrollment Period

8 months

First QC Date

February 23, 2025

Last Update Submit

February 23, 2025

Conditions

Keywords

amputeemotion analysiskinematicsreliability

Outcome Measures

Primary Outcomes (1)

  • Vİdeo Recording

    The gait of the individuals will be recorded to determine the sagittal plane knee angular values during walking: Participants will be asked to wear comfortable clothing to avoid limitation of movement. Before recording any measurements, participants will be asked to walk a few laps around the test area to familiarize them with the procedure and the movements being measured. Video images of each participant will be acquired using a digital camera (Canon EOS600D) to capture the sagittal plane profile of the knee. The camera will be placed on a tripod at a height of 80 cm, 1.5 m away from the participants. The tripod will be placed on taped markers on the floor to maintain the same distance between the camera and the participants. All images will be transferred to a laptop and analyzed using Kinovea software, a free, open source software created for motion analysis (Kinovea, 0.8.15, http://www.kinovea.org/).

    From enrollment to the end of video record (10 minutes).

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals who have unilateral transtibial amputation

You may qualify if:

  • Having a unilateral below-knee (transtibial) level amputation,
  • Using a prosthesis and being able to walk with the prosthesis,
  • Body mass index less than 30,
  • No contracture in the intact or amputated knee.
  • Not having had any surgery related to the knees.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Sciences

Ankara, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

February 23, 2025

First Posted

February 27, 2025

Study Start

December 1, 2024

Primary Completion

August 1, 2025

Study Completion

August 15, 2025

Last Updated

February 27, 2025

Record last verified: 2024-09

Locations