AmputationNCT06390033

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

An observational study of Amputation and Prosthesis User, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 36 to 64 years
Conditions the study is for: Amputation, Prosthesis User
What is being tested?: Prosthetic foot
Type of treatment: Medical device
How many people: 6 participants
Where: 1 siteHong Kong
Study dates: 30 Jun 2023to 30 Jun 2024
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 36 to 64 years
All sexes
No healthy volunteers
Adult

Study population: Six unilateral transtibial amputees (two females and four males) (age: (mean ± SD) 52.5 ± 12.1 years; height: 170.5 ± 10.5 cm; weight: 71.5 ± 6.5 kg; years using a prosthetic: 31 ± 10.8 years) were recruited in this study.

Who may be able to join

unilateral transtibial amputees,
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.

Who cannot join

with a short or an injured residual limb,
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.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

The Hong Kong Polytechnic University
Kowloon, Hong Kong, 999077

Other trials in Hong Kong

About this study

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?
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

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.
Participants are asked to refrain from consuming caffeine or any stimulants for 24 hours before the tests.
Participants will be required to perform the Berg Balance Test.
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.
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.
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.
Participants will be asked to perform a 2-minute walking test on flat concrete ground, stairs, and a ramp, respectively.
Finally, participants will be asked to complete the Locomotion Capabilities Index questionnaire.

Read the detailed description

Thirty-nine passive-reflective markers of 14 mm in diameter were placed on the participant (Figure 1) according to the landmarks set of the plug-in full body model. An 8-camera motion capturing system (VICON, Nexus 2.0 Inc., Oxford, UK) and 2 force plates (AMTI, Advanced Mechanical Technology, Inc., Watertown, USA) mounted under the walkway were utilized for gait analysis and recorded 100 frames per second simultaneously. All the systems were calibrated before the experiment.

Conditions: Amputation, Prosthesis User
Being tested: Prosthetic foot
Keywords: unilateral transtibial amputee, low-cost prosthetic foot, elevated activities, biomechanical study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prosthetic footDevice
Experimental prosthetic foot.

Study groups in NCT06390033
Study group	Role	What they receive
K2 or above prosthesis		Unilateral transtibial amputees will engage in both indoor and outdoor activities, utilizing their own prosthesis (control). Receives: Device: Prosthetic foot
A low-cost prosthesis		Unilateral transtibial amputees will engage in both indoor and outdoor activities, utilizing an experimental prosthesis Receives: Device: Prosthetic foot

What is being measured

The primary outcome is the main question the study is designed to answer.

Basic mobility function with two prostheses by Berg Balance Test
Participants will be invited to visit the laboratory twice to participate in two prostheses will be compared by conducting Berg Balance Test including 14 items, each item is graded using a 5-point ordinal scale ranging from 0 to 4. 0-20 indicates high fall risk, 21-40 indicates medium fall risk, 41-56 indicates low fall risk.
Measured: up to 12 weeks
Basic mobility function with two prostheses by Time to Go Up
Participants will be invited to visit the laboratory twice to participate in two prostheses will be compared by conducting Time to Go Up (seconds), including stand up from chair, walk 3 meters, turn around and back, then sit. Longer than 13.5 seconds indicates high risk of fall.
Measured: up to 12 weeks
Basic mobility function with two prostheses by Four Square Step Test
Participants will be invited to visit the laboratory twice to participate in two prostheses will be compared by conducting Four Square Step Test (seconds).
Measured: up to 12 weeks
Basic mobility function with two prostheses by 10-meter Walk Test
Participants will be invited to visit the laboratory twice to participate in two prostheses will be compared by conducting 10-Meter Walk Test (m/s).
Measured: up to 12 weeks
Stability index with two prostheses by Eye Close Standing
Participants will be invited to the laboratory twice to participate in an experiment. In each session, they will be required to perform the Eye Close Standing on a force plate (Bertect, Ohio, USA). The test will be conducted three times, with each attempt lasting 30 seconds. Participants will perform the task using either a low-cost prosthesis or their own prosthetic foot. The averaged anterior-posterior stability index (mm), and medial-lateral stability index (mm) will be calculated automatically by Noraxon software for each task to assess the ability of maintaining posture stability with two prostheses.
Measured: up to 12 weeks
Stability index with two prostheses by Tandem Test
Participants will be invited to the laboratory twice to participate in an experiment. In each session, they will be required to perform the Tandem Test on a force plate (Bertect, Ohio, USA). The test will be conducted three times, with each attempt lasting 30 seconds. Participants will perform the task using either a low-cost prosthesis or their own prosthetic foot. The averaged anterior-posterior stability index (mm), and medial-lateral stability index (mm) will be calculated automatically by Noraxon software for each task to assess the ability of maintaining posture stability with two prostheses.
Measured: up to 12 weeks
Functional Reach Test
Participants will move from the vertical standing position to the maximum lean forward position, with the feet firmly placed on the floor with either prosthetic foot for three times. The averaged distance (cm) with two prostheses will be compared.
Measured: up to 12 weeks
Gait analysis with two prostheses
For collecting the kinematic and kinetic data for gait analysis, thirty-nine passive-reflective markers were placed on the participant according to the landmarks set of the plug-in full body model. An 8-camera motion capturing system (VICON, Nexus 2.0 Inc., Oxford, UK) and 2 force plates (AMTI, Advanced Mechanical Technology, Inc., Watertown, USA) mounted under the walkway were recorded 100 frames per second simultaneously. All the systems were calibrated before the experiment. 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.
Measured: up to 12 weeks
Jump feasibility with two prostheses
Participants will be invited to visit the laboratory twice to participate in an experiment. During each visit, they will be asked to perform the countermovement jump on the force plate (Bertect, Ohio, USA) for three times, using either a low-cost prosthesis or their own prosthetic foot. The average of three times jump height, vertical ground reaction force during different jump phases with two different prostheses will be compared.
Measured: up to 12 weeks
Subjective evaluation by Locomotion Capabilities Index questionnaire
Participants will be asked to complete the Locomotion Capabilities Index questionnaire including 14 items, each item is rated with a 5-level scale. 0 indicates unable to perform, 4 indicates no difficulty.
Measured: up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 202330 Jun 2024

First posted29 Apr 2024
Study start30 Jun 2023
Primary completion30 Apr 2024
Study completion30 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for AmputationStudies of the same condition, open and under way.
More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Cross-sectional
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06390033
Sponsor's protocol ID: ITS/133/21
Status last verified: Apr 2024
First submitted: 13 Mar 2024
Last updated: 15 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD data related to this project will be only for publication purposes.

Publications

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.
PubMed 28704685
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.
PubMed 25802425
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.
PubMed 15129398
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.
PubMed 17436172
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.
PubMed 37892868
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.
PubMed 24597518
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.
PubMed 30112982
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.
PubMed 1468055
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.
PubMed 12422327
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.
PubMed 22389424
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.
PubMed 10960937

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingObservational study
CNS Changes Following Upper Limb Loss
Amputation, Congenital, Upper Limb; Amelia
Recruiting
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All Amputation trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Biomechanical Study of Different Prostheses for Unilateral Transtibial Amputees During Indoor and Outdoor Activities
ClinicalTrials.gov ID: NCT06390033
Acronym / sponsor ID: ITS/133/21
Conditions: Amputation, Prosthesis User
Keywords: unilateral transtibial amputee, low-cost prosthetic foot, elevated activities, biomechanical study
Study type: Observational
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: The Hong Kong Polytechnic UniversityUniversity, hospital or other
Study start: 30 Jun 2023 (actual)
Primary completion: 30 Apr 2024 (actual)
Study completion: 30 Jun 2024 (actual)
First posted: 29 Apr 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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?
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

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.
Participants are asked to refrain from consuming caffeine or any stimulants for 24 hours before the tests.
Participants will be required to perform the Berg Balance Test.
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.
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.
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.
Participants will be asked to perform a 2-minute walking test on flat concrete ground, stairs, and a ramp, respectively.
Finally, participants will be asked to complete the Locomotion Capabilities Index questionnaire.

Detailed description

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
K2 or above prosthesis	–	Device: Prosthetic footUnilateral transtibial amputees will engage in both indoor and outdoor activities, utilizing their own prosthesis (control).
A low-cost prosthesis	–	Device: Prosthetic footUnilateral transtibial amputees will engage in both indoor and outdoor activities, utilizing an experimental prosthesis

Who may qualify

Ages: 36 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult
Study population: Six unilateral transtibial amputees (two females and four males) (age: (mean ± SD) 52.5 ± 12.1 years; height: 170.5 ± 10.5 cm; weight: 71.5 ± 6.5 kg; years using a prosthetic: 31 ± 10.8 years) were recruited in this study.

Key inclusion criteria (4 listed)

unilateral transtibial amputees,
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.

Key exclusion criteria (8 listed)

with a short or an injured residual limb,
pregnant,
any neurological or musculoskeletal diseases,
have a record of active endocarditis and acute myocarditis/pericarditis,
experience ongoing unstable angina,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Prosthetic footExperimental prosthetic foot.	Device	A low-cost prosthesis, K2 or above prosthesis

Primary outcome

Basic mobility function with two prostheses by Berg Balance Test
Time frame: up to 12 weeks
Participants will be invited to visit the laboratory twice to participate in two prostheses will be compared by conducting Berg Balance Test including 14 items, each item is graded using a 5-point ordinal scale ranging from 0 to 4. 0-20 indicates high fall risk, 21-40 indicates medium fall risk, 41-56 indicates low fall risk.
Basic mobility function with two prostheses by Time to Go Up
Time frame: up to 12 weeks
Participants will be invited to visit the laboratory twice to participate in two prostheses will be compared by conducting Time to Go Up (seconds), including stand up from chair, walk 3 meters, turn around and back, then sit. Longer than 13.5 seconds indicates high risk of fall.
Basic mobility function with two prostheses by Four Square Step Test
Time frame: up to 12 weeks
Participants will be invited to visit the laboratory twice to participate in two prostheses will be compared by conducting Four Square Step Test (seconds).
Basic mobility function with two prostheses by 10-meter Walk Test
Time frame: up to 12 weeks
Participants will be invited to visit the laboratory twice to participate in two prostheses will be compared by conducting 10-Meter Walk Test (m/s).
Stability index with two prostheses by Eye Close Standing
Time frame: up to 12 weeks
Participants will be invited to the laboratory twice to participate in an experiment. In each session, they will be required to perform the Eye Close Standing on a force plate (Bertect, Ohio, USA). The test will be conducted three times, with each attempt lasting 30 seconds. Participants will perform the task using either a low-cost prosthesis or their own prosthetic foot. The averaged anterior-posterior stability index (mm), and medial-lateral stability index (mm) will be calculated automatically by Noraxon software for each task to assess the ability of maintaining posture stability with two prostheses.
Stability index with two prostheses by Tandem Test
Time frame: up to 12 weeks
Participants will be invited to the laboratory twice to participate in an experiment. In each session, they will be required to perform the Tandem Test on a force plate (Bertect, Ohio, USA). The test will be conducted three times, with each attempt lasting 30 seconds. Participants will perform the task using either a low-cost prosthesis or their own prosthetic foot. The averaged anterior-posterior stability index (mm), and medial-lateral stability index (mm) will be calculated automatically by Noraxon software for each task to assess the ability of maintaining posture stability with two prostheses.
Functional Reach Test
Time frame: up to 12 weeks
Participants will move from the vertical standing position to the maximum lean forward position, with the feet firmly placed on the floor with either prosthetic foot for three times. The averaged distance (cm) with two prostheses will be compared.
Gait analysis with two prostheses
Time frame: up to 12 weeks
For collecting the kinematic and kinetic data for gait analysis, thirty-nine passive-reflective markers were placed on the participant according to the landmarks set of the plug-in full body model. An 8-camera motion capturing system (VICON, Nexus 2.0 Inc., Oxford, UK) and 2 force plates (AMTI, Advanced Mechanical Technology, Inc., Watertown, USA) mounted under the walkway were recorded 100 frames per second simultaneously. All the systems were calibrated before the experiment. 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.
Jump feasibility with two prostheses
Time frame: up to 12 weeks
Participants will be invited to visit the laboratory twice to participate in an experiment. During each visit, they will be asked to perform the countermovement jump on the force plate (Bertect, Ohio, USA) for three times, using either a low-cost prosthesis or their own prosthetic foot. The average of three times jump height, vertical ground reaction force during different jump phases with two different prostheses will be compared.
Subjective evaluation by Locomotion Capabilities Index questionnaire
Time frame: up to 12 weeks
Participants will be asked to complete the Locomotion Capabilities Index questionnaire including 14 items, each item is rated with a 5-level scale. 0 indicates unable to perform, 4 indicates no difficulty.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
Results publication: PubMed 28704685Kent 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.
Results publication: PubMed 25802425Pickenbrock 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.
Results publication: PubMed 15129398Franchignoni 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.
Results publication: PubMed 17436172Segal 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.
Results publication: PubMed 37892868Shi 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.
Results publication: PubMed 24597518Arifin 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.
Results publication: PubMed 30112982Batten 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.
Results publication: PubMed 1468055Berg 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.
Results publication: PubMed 12422327Dite 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.
Results publication: PubMed 22389424Gremeaux 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.
Results publication: PubMed 10960937Shumway-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.
Individual participant dataSharing planned: Yes. IPD data related to this project will be only for publication purposes.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kit-lun Yick, PhD principal investigator

The Hong Kong Polytechnic University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Amputation and Prosthesis User, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Basic mobility function with two prostheses by Berg Balance Test (time frame: up to 12 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06390033, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.