CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 6 enrolled
Drug / intervention
Prosthetic footdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06390033
NCT06390033N/ACompleted

Biomechanical Study of Different Prostheses for Unilateral Transtibial Amputees During Indoor and Outdoor Activities

The Hong Kong Polytechnic University·observational·Posted Apr 29, 2024·Updated Sep 15, 2025

In Brief

An observational study evaluating Prosthetic foot for Amputation and Prosthesis User. Completed, enrolled 6 participants across 1 site.

Detailed Summary

The goal of this observational study is to evaluate and compare the performance of two prosthetic feet for unilateral transtibial amputees during both indoor and outdoor activities. The main research questions aim to answer are: 1. Can a low-cost prosthetic foot enhance gait mechanics and physical performance in individuals who have undergone traumatic unilateral transtibial amputation, as compared to the traditional K2 - K3 prosthetic feet currently available on the market, during both indoor and outdoor activities? 2. Can the low-cost prosthetic foot meet user satisfaction levels after traumatic unilateral transtibial amputation, when compared to the traditional K2 - K3 prosthetic foot on the market? Participants will be asked to do 1. Prior to the commencement of the experiment, a professional prosthetist and orthotist will conduct all fitting and alignment procedures for the transtibial amputees. Participants will then be given a two to three-week period to train and acclimate to the individual socket alignment and prosthetic foot. 2. Participants are asked to refrain from consuming caffeine or any stimulants for 24 hours before the tests. 3. Participants will be required to perform the Berg Balance Test. 4. Participants will undergo a series of clinical tests, including: 1) Time to Go Up (measured in seconds), 2) Four Square Step Test (measured in seconds), 3) 10-Meter Walk Test (measured in seconds), 4) Eye Close Standing, 5) Tandem Test, and 6) Functional Reach Test. Each test will be conducted three times. The test items of 4) and 5) will be performed on a force plate (Bertect, Ohio, USA) with dimensions of 400 x 600 mm and a capturing frequency of 1,000 Hz. 5. Participants will be asked to walk on a force plate (AMTI, Advanced Mechanical Technology, Inc., Watertown, USA) at a fixed walking speed of 1.11 ± 0.11m/s, allowing the foot to land naturally on the force plate. Five trials of the gait cycle with a clean foot will be used for analysis. 6. Participants will perform the Counter Movement Jump Test three times with maximum effort on the force plate (Bertect, Ohio, USA), which will be performed without a hand swing. 7. Participants will be asked to perform a 2-minute walking test on flat concrete ground, stairs, and a ramp, respectively. 8. Finally, participants will be asked to complete the Locomotion Capabilities Index questionnaire.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesHong Kong
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedApr 29, 2024
Enrollment StartJun 30, 2023
Primary CompletionApr 30, 2024
Study CompletionJun 30, 2024
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 2.2 years ago

Interventions

Prosthetic footdevice

Experimental prosthetic foot.