The Effect of Different Measurement-manufacturing Techniques on Load Distribution in Amputees
27 mars 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Anticipé)
30
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
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Istanbul, Turquie, 34000
- Marmara University
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 70 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
Unilateral transtibial amputees
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Group 1
Unilateral transtibial amputees using conventinional manufactured socket
|
Presssure disturubition will be measured in conventional manufactured socket during walking and stairing up and down activities in unilateral transtibial amputees
|
|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Measurement of load distrubution on stump in conventional manufactured socket
Délai: 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 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
Délai: 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
Délai: 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.
|
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
Délai: 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
|
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
Délai: Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during walking
|
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
Délai: Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during walking
|
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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: yasar tatar, Marmara University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
6 septembre 2019
Achèvement primaire (Anticipé)
10 avril 2020
Achèvement de l'étude (Anticipé)
30 juin 2020
Dates d'inscription aux études
Première soumission
25 mars 2020
Première soumission répondant aux critères de contrôle qualité
27 mars 2020
Première publication (Réel)
30 mars 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
30 mars 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
27 mars 2020
Dernière vérification
1 avril 2019
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 09.2019.359
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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