Daily socket comfort in transtibial amputee with a vacuum-assisted suspension system: study protocol of a randomized, multicenter, double-blind multiple N-of-1 trial.

Fiche publication

Date publication

juillet 2023

Journal

BMC sports science, medicine & rehabilitation

Auteurs

Membres identifiés du Cancéropôle Est :
Pr GODET Julien

Tous les auteurs :
Klotz R, Emile G, Daviet JC, De Sèze M, Godet J, Urbinelli R, Krasny-Pacini A

Lien Pubmed

https://www.ncbi.nlm.nih.gov/pubmed/37452356

Résumé

The main aim of this paper is to present the feasibility of rigorously designed multiple N-of-1 design in prosthetics research. While research of adequate power and high quality is often lacking in rehabilitation, N-of-1 trials can offer a feasible alternative to randomized controlled group trials, both increasing design power at group level and allowing a rigorous, statistically confirmed evaluation of effectiveness at a single patient level. The paper presents a multiple N-of-1 trial protocol, which aim is to evaluate the effectiveness of Unity, a prosthetic add-on suspension system for amputees, on patient-reported comfort during daily activities (main outcome measure), prosthesis wearing time, perception of limb-prosthesis fitting and stump volume and functional walking parameters.