The Effect of Different Measurement-manufacturing Techniques on Load Distribution in Amputees
27 maart 2020 bijgewerkt door: Marmara University
The Effect of Different Measurement-manufacturing Techniques on Stump and Soles Load Distribution in Transtibial Knee Prostheses
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.
Studie Overzicht
Toestand
Onbekend
Conditie
Interventie / Behandeling
Studietype
Observationeel
Inschrijving (Verwacht)
30
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Istanbul, Kalkoen, 34000
- Marmara University
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 70 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
Unilateral transtibial amputees
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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Group 1
Unilateral transtibial amputees using conventinional manufactured socket
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Presssure disturubition will be measured in conventional manufactured socket during walking and stairing up and down activities in unilateral transtibial amputees
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Group 2
Unilateral transtibial amputees using 3D manufactured socket
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Presssure disturubition will be measured in 3D manufactured socket during walking and stairing up and down activities in unilateral transtibial amputees
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Measurement of load distrubution on stump in conventional manufactured socket
Tijdsspanne: Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking
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Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking.
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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
Tijdsspanne: Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking
|
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
Tijdsspanne: Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs.
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Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs.
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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
Tijdsspanne: Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs
|
Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs
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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
Tijdsspanne: Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during walking
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Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during walking
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Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during walking
|
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Measurement of sole load distrubution (mmHg/N/Kg) in 3D-manufactured socket
Tijdsspanne: Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during walking
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Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during walking
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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
Tijdsspanne: Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during climbing up and down stairs
|
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
Tijdsspanne: Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during climbing up and down stairs
|
Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during climbing up and down stairs
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Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during climbing up and down stairs
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: yasar tatar, Marmara University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Dou P, Jia X, Suo S, Wang R, Zhang M. Pressure distribution at the stump/socket interface in transtibial amputees during walking on stairs, slope and non-flat road. Clin Biomech (Bristol, Avon). 2006 Dec;21(10):1067-73. doi: 10.1016/j.clinbiomech.2006.06.004. Epub 2006 Aug 17.
- Jia X, Suo S, Meng F, Wang R. Effects of alignment on interface pressure for transtibial amputee during walking. Disabil Rehabil Assist Technol. 2008 Nov;3(6):339-43. doi: 10.1080/17483100802044634.
- Xiaohong J, Xiaobing L, Peng D, Ming Z. The Influence of Dynamic Trans-tibial Prosthetic Alignment on Standing Plantar Foot Pressure. Conf Proc IEEE Eng Med Biol Soc. 2005;2005:6916-8. doi: 10.1109/IEMBS.2005.1616096.
- Lee VS, Solomonidis SE, Spence WD. Stump-socket interface pressure as an aid to socket design in prostheses for trans-femoral amputees--a preliminary study. Proc Inst Mech Eng H. 1997;211(2):167-80. doi: 10.1243/0954411971534287.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
6 september 2019
Primaire voltooiing (Verwacht)
10 april 2020
Studie voltooiing (Verwacht)
30 juni 2020
Studieregistratiedata
Eerst ingediend
25 maart 2020
Eerst ingediend dat voldeed aan de QC-criteria
27 maart 2020
Eerst geplaatst (Werkelijk)
30 maart 2020
Updates van studierecords
Laatste update geplaatst (Werkelijk)
30 maart 2020
Laatste update ingediend die voldeed aan QC-criteria
27 maart 2020
Laatst geverifieerd
1 april 2019
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 09.2019.359
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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