Biomechanical Study of Different Prostheses for Unilateral Transtibial Amputees During Indoor and Outdoor Activities
NCT ID: NCT06390033
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
6 participants
OBSERVATIONAL
2023-06-30
2024-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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K2 or above prosthesis
Unilateral transtibial amputees will engage in both indoor and outdoor activities, utilizing their own prosthesis (control).
Prosthetic foot
Experimental prosthetic foot.
A low-cost prosthesis
Unilateral transtibial amputees will engage in both indoor and outdoor activities, utilizing an experimental prosthesis
Prosthetic foot
Experimental prosthetic foot.
Interventions
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Prosthetic foot
Experimental prosthetic foot.
Eligibility Criteria
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Inclusion Criteria
* with more than 12 months of experience using a prosthesis,
* with a K2 prosthesis or above,
* be able to walk continuously unaided with the prosthetic foot for at least 20 minutes.
Exclusion Criteria
* pregnant,
* any neurological or musculoskeletal diseases,
* have a record of active endocarditis and acute myocarditis/pericarditis,
* experience ongoing unstable angina,
* have uncontrolled cardiac arrhythmia with hemodynamic compromise,
* have had a recent stroke or transient ischemic attack,
* have high blood pressure, etc.
36 Years
64 Years
ALL
No
Sponsors
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The Hong Kong Polytechnic University
OTHER
Responsible Party
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YICK Kit Lun
Professor
Principal Investigators
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Kit-lun Yick, PhD
Role: PRINCIPAL_INVESTIGATOR
The Hong Kong Polytechnic University
Locations
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The Hong Kong Polytechnic University
Kowloon, Hong Kong, Hong Kong
Countries
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References
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Kent JA, Stergiou N, Wurdeman SR. Dynamic balance changes within three weeks of fitting a new prosthetic foot component. Gait Posture. 2017 Oct;58:23-29. doi: 10.1016/j.gaitpost.2017.07.003. Epub 2017 Jul 5.
Pickenbrock HM, Diel A, Zapf A. A comparison between the Static Balance Test and the Berg Balance Scale: validity, reliability, and comparative resource use. Clin Rehabil. 2016 Mar;30(3):288-93. doi: 10.1177/0269215515578297. Epub 2015 Mar 23.
Franchignoni F, Orlandini D, Ferriero G, Moscato TA. Reliability, validity, and responsiveness of the locomotor capabilities index in adults with lower-limb amputation undergoing prosthetic training. Arch Phys Med Rehabil. 2004 May;85(5):743-8. doi: 10.1016/j.apmr.2003.06.010.
Segal AD, Orendurff MS, Klute GK, McDowell ML, Pecoraro JA, Shofer J, Czerniecki JM. Kinematic and kinetic comparisons of transfemoral amputee gait using C-Leg and Mauch SNS prosthetic knees. J Rehabil Res Dev. 2006 Nov-Dec;43(7):857-70. doi: 10.1682/jrrd.2005.09.0147.
Shi QQ, Yick KL, Wu J, Huang X, Tse CY, Chan MK. A Scientometric Analysis and Visualization of Prosthetic Foot Research Work: 2000 to 2022. Bioengineering (Basel). 2023 Sep 28;10(10):1138. doi: 10.3390/bioengineering10101138.
Arifin N, Abu Osman NA, Ali S, Wan Abas WA. The effects of prosthetic foot type and visual alteration on postural steadiness in below-knee amputees. Biomed Eng Online. 2014 Mar 5;13(1):23. doi: 10.1186/1475-925X-13-23.
Batten HR, McPhail SM, Mandrusiak AM, Varghese PN, Kuys SS. Gait speed as an indicator of prosthetic walking potential following lower limb amputation. Prosthet Orthot Int. 2019 Apr;43(2):196-203. doi: 10.1177/0309364618792723. Epub 2018 Aug 16.
Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S7-11.
Dite W, Temple VA. A clinical test of stepping and change of direction to identify multiple falling older adults. Arch Phys Med Rehabil. 2002 Nov;83(11):1566-71. doi: 10.1053/apmr.2002.35469.
Gremeaux V, Damak S, Troisgros O, Feki A, Laroche D, Perennou D, Benaim C, Casillas JM. Selecting a test for the clinical assessment of balance and walking capacity at the definitive fitting state after unilateral amputation: a comparative study. Prosthet Orthot Int. 2012 Dec;36(4):415-22. doi: 10.1177/0309364612437904. Epub 2012 Mar 2.
Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000 Sep;80(9):896-903.
Other Identifiers
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ITS/133/21
Identifier Type: -
Identifier Source: org_study_id
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