The Effect of Different Measurement-manufacturing Techniques on Load Distribution in Amputees

Study Overview
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Brief Summary
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Alignment of the prosthesis with the stump is performed through the socket. Good socket stump fit provides near-normal posture and weight-transfer pattern. It also ensures that the walk is painless and low-energy. Recently, studies have been carried out to use 3D printers in socket production. 3D method is accepted as an effective and reliable method in prosthetic socket production. The purpose of this study is to compare the pressures distrubution in the sockets produced by conventional and 3D scanners and printers in the transtibial amputee.

Official Title
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The Effect of Different Measurement-manufacturing Techniques on Stump and Soles Load Distribution in Transtibial Knee Prostheses

Conditions
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Transtibial Amputee, Loading, Conventional, 3D

Intervention / Treatment
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* Other: conventional manufactured socket
* Other: 3D manufactured socket


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being unilateral transtibial amputation To have enough perception level to understand and apply commands Exclusion Criteria: To have orthopedic, neurological, etc. disorder other than amputation that will affect posture or gait The presence of pain that will affect the posture or walking pattern Wound / tenderness on the stump Visual impairment that will affect the posture or gait pattern Use of any assistive device (walking stick, canary, etc.) during walking

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Unilateral transtibial amputees using conventinional manufactured socket | Other: conventional manufactured socket<br>* Presssure disturubition will be measured in conventional manufactured socket during walking and stairing up and down activities in unilateral transtibial amputees<br>|
| Group 2<br>Unilateral transtibial amputees using 3D manufactured socket | Other: 3D manufactured socket<br>* Presssure disturubition will be measured in 3D manufactured socket during walking and stairing up and down activities in unilateral transtibial amputees<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of load distrubution on stump in conventional manufactured socket | Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking. | Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking | 
| Measurement of load distrubution on stump in 3D manufactured socket | Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket sensories during walking. | Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking | 
| Measurement of load distrubution on stump in conventional manufactured socket | Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs. | Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs. | 
| Measurement of load distrubution on stump in 3D-manufactured socket | Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs | Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs | 
| Measurement of sole load distrubution (mmHg/N/Kg) in conventional manufactured socket | Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during walking | Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during walking | 
| Measurement of sole load distrubution (mmHg/N/Kg) in 3D-manufactured socket | Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during walking | Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during walking | 
| Measurement of sole load distrubution (mmHg/N/Kg) in conventional manufactured socket | Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during climbing up and down stairs | Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during climbing up and down stairs | 
| Measurement of sole load distrubution (mmHg/N/Kg) in 3D-manufactured socket | Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during climbing up and down stairs | Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during climbing up and down stairs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amputee, loading, 3D