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- W4245451013 abstract "ActiMyoⓇ is a wearable device aiming to be used in clinical trials studying patients’ upper-and lower-limb movements. The 95th centile of Stride Velocity (SV95C), i.e. the speed of the five percent fastest strides, is an output from ActiMyoⓇ. It represents the walk/run maximal performance of a subject. SV95C has been qualified by the EMA as a secondary endpoint in clinical trial on ambulant patients presenting with Duchenne muscular dystrophy. Content validation plays an important role in the development of any new instrument. It provides evidence about the validity of an instrument by assessing the degree to which the instrument measures the targeted concept. As part of the content validity, to assess the clinical meaningfulness of ActiMyoⓇ’s outputs, we build an online survey aiming to collect opinion, expectations and concerns regarding the use of the wearable device in clinical trial and the clinical meaningfulness of its potential outputs. The survey is developed in collaboration between, Sysnav, the company developing ActiMyoⓇ, physician expert in neuromuscular diseases and members of patient groups. The final version will be constructed with the SurveyMonkey website. Before the launch, the survey will be tested for technical functionality, and then sent by email to patients and caregivers by patients groups. Data will be completely anonymous. Respondents will be characterized by group (patients vs family/caregivers), pathology, ambulant status and age. Here we report the qualitative assessment through an online survey of the content validity of the ActiMyoⓇ outcome measures and their appropriateness for use in clinical trials on neuromuscular diseases." @default.
- W4245451013 created "2022-05-12" @default.
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- W4245451013 date "2020-10-01" @default.
- W4245451013 modified "2023-09-26" @default.
- W4245451013 title "OUTCOME MEASURES" @default.
- W4245451013 doi "https://doi.org/10.1016/j.nmd.2020.08.248" @default.
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