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Master Thesis

Confort en milieu écologique chez la personne présentant une amputation transtibiale équipée d’un système à dépressurisation active : protocole de recherche d’une étude de type N-of-1 trial, randomisée, multicentrique, en double-aveugle

Abstract : Background: vacuum suspension could improve comfort and quality of life for people with limb loss. Research is lacking to inform clinical practice, especially according to prospective studies in the ecological environment. Objective: the aim of this study is to evaluate the comfort of the UnityTM elevated vacuum system in daily routine in individuals with unilateral transtibial amputation. Methods and design. A multicenter, randomized, prospective, double-blind clinical N-of-1 trial will be performed. People (n = 20) with unilateral transtibial amputation will be fit with the Ossur UnityTM elevated vacuum suspension system. After one-month accommodation period, they will be randomly distributed into active or inactive vacuum 7 to 28 days phases with at least three phase change and a maximum of 50 days. Comfort will be daily assessed with the 0 to 10 Socket Comfort Score in the ecological environment as well as function scores at each phase change. Discussion: we believe that an approach in an ecological environment and with daily measures will stick to reality. Also, this method seems to be more appropriate for assessing this population with a high level of evidence. Large randomized controlled trials are difficult to adapt to the small amputee population. N-of-1 trial is particularly suitable for the on/off effect of active vacuum systems combining a high level of evidence with a small sample size. The results of this study could provide valuable insight to enhance the understanding of VASS and to guide the choice of patients with unilateral transtibial amputation and prescribers.
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https://dumas.ccsd.cnrs.fr/dumas-03048550
Contributor : Médecine Ub <>
Submitted on : Wednesday, December 9, 2020 - 2:03:52 PM
Last modification on : Tuesday, January 26, 2021 - 3:10:16 AM

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Guilhem Emile. Confort en milieu écologique chez la personne présentant une amputation transtibiale équipée d’un système à dépressurisation active : protocole de recherche d’une étude de type N-of-1 trial, randomisée, multicentrique, en double-aveugle. Sciences du Vivant [q-bio]. 2020. ⟨dumas-03048550⟩

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