Clinical trial NCT06390033: Biomechanical Study of Different Prostheses for Unilateral Transtibial Amputees During Indoor and Outdoor Activities
Official title: Biomechanical Study of Different Prostheses for Unilateral Transtibial Amputees During Indoor and Outdoor Activities
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Amputation
Prosthesis User
Keywords: unilateral transtibial amputee
low-cost prosthetic foot
elevated activities
biomechanical study
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 6
Sex: ALL
Minimum age (years): 36
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Basic mobility function with two prostheses by Berg Balance Test
timeFrame: up to 12 weeks
measure: Basic mobility function with two prostheses by Time to Go Up
timeFrame: up to 12 weeks
measure: Basic mobility function with two prostheses by Four Square Step Test
timeFrame: up to 12 weeks
measure: Basic mobility function with two prostheses by 10-meter Walk Test
timeFrame: up to 12 weeks
measure: Stability index with two prostheses by Eye Close Standing
timeFrame: up to 12 weeks
measure: Stability index with two prostheses by Tandem Test
timeFrame: up to 12 weeks
measure: Functional Reach Test
timeFrame: up to 12 weeks
measure: Gait symmetry analysis of lower limb joint angle
timeFrame: up to 12 weeks
measure: Gait symmetry analysis of lower limb joint power
timeFrame: up to 12 weeks
measure: Gait symmetry analysis of lower limb joint moment
timeFrame: up to 12 weeks
measure: Walking feasibility with two prostheses
timeFrame: up to 12 weeks
measure: Jump feasibility with two prostheses
timeFrame: up to 12 weeks
measure: Subjective evaluation by Locomotion Capabilities Index questionnaire
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Kit-lun Yick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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