Comparison between a novel helical and a posterior ankle-foot orthosis on gait in people with unilateral foot drop: a randomised crossover trial.

"Declarations Ethics approval and consent to participateEthical approval was granted by the institutional review board at our facility (CPP RC31/16/8711UA 0961/2016; 2016-AO1037-44) and all participants gave informed consent for their participation. Consent for publicationNot applicable. Competing interestsOne of the authors, Benoit Caussé is the inventor of the orthosis [21]. He did not participate in any of the data collection. This study was promoted by InnovPulse, i.e., InnovPulse paid the insurance, paid the hospital for study-related costs (evaluations and orthoses), covered participant transport costs and paid a contract research organisation to draft the protocol and documents for ethical approval. The promotor played no part in the study design, data collection, data analysis or writing of this article. Competing interests One of the authors, Benoit Caussé is the inventor of the orthosis [21]. He did not participate in any of the data collection. This study was promoted by InnovPulse, i.e., InnovPulse paid the insurance, paid the hospital for study-related costs (evaluations and orthoses), covered participant transport costs and paid a contract research organisation to draft the protocol and documents for ethical approval. The promotor played no part in the study design, data collection, data analysis or writing of this article."

"Funding Funding was provided by InnovPulse."

"Trial registration The trial began before registration was mandatory"