ArticleJournal of neuromuscular diseases2022
Stride Velocity 95th Centile: Insights into Gaining Regulatory Qualification of the First Wearable-Derived Digital Endpoint for use in Duchenne Muscular Dystrophy Trials.
Article in Journal of neuromuscular diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 55 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
55 citing papers in PubMed, 3 syntheses or guidelines pooled it, 75 citations in OpenAlex.
- Identifying Concepts of Physical Activity Which Are Clinically Meaningful to Patients and Care Providers: A Systematic Review of Qualitative Research.Clinical and translational science · 2025Pooled it
- Concurrent Validity Evidence for Pressure-Sensing Walkways Measuring Spatiotemporal Features of Gait: A Systematic Review and Meta-Analysis.Sensors (Basel, Switzerland) · 2024Pooled it
- The use of digital outcome measures in clinical trials in rare neurological diseases: a systematic literature review.Orphanet journal of rare diseases · 2023Pooled it
- AAV gene therapy for Duchenne muscular dystrophy: the EMBARK phase 3 randomized trial.Nature medicine · 2025Trial
- Artificial Intelligence in Neuromuscular Diseases: Opportunities for a Data-Scarce Field.Neurology and therapy · 2026Review
- Article
- Powering Neurology Drug Development Trials to Reduce False Negative Results.Clinical and translational science · 2026Review
- Feasibility, validation and application of digital tools for remote monitoring in neuromuscular diseases: the DT4RD protocol.BMJ open · 2026Article
- Assessing movement quality in individuals with Duchenne muscular dystrophy utilizing accelerometry: Comparisons with healthy controls.PLOS digital health · 2026Article
- Artificial Intelligence in Drug Discovery and Development: Raising Quality per Decision.Pharmacopsychiatry · 2026Review
- Using wearable sensors during the timed up and go and 6-minute walk test in Spinal Bulbar Muscular Atrophy.PLOS digital health · 2026Article
- Non-invasive biomarkers for diagnosis and monitoring of primary mitochondrial diseases.Journal of neurology · 2026Review
- WearGait-PD: An Open-Access Wearables Dataset for Gait in Parkinson's Disease and Age-Matched Controls.Scientific data · 2026Article
- Six-Minute Activity-95Pediatric neurology · 2026Observational
- Digital outcome measures in Duchenne muscular dystrophy: Lessons learnt from clinical trials.Journal of neuromuscular diseases · 2026Review
- Objective Assessment of Media Screens Effect on Physical Activity in Preschool Children.IEEE access : practical innovations, open solutions · 2026Article
- Feasibility of a Home-Based Exergaming Intervention for Youth With Spinal Muscular Atrophy.Muscle & nerve · 2025Article
- Exploring the role of digital health technologies in assessing functional mobility and physical activity: Insights from qualitative interviews in adults with obesity or overweight.Obesity pillars · 2025Article
- The interplay between pitch control and top speed in soccer considering the stamina factor.Scientific reports · 2025Article
- Integrated Modeling of Digital-Motor and Clinician-Reported Outcomes Using Item Response Theory: Towards Powerful Trials for Rare Neurological Diseases.CPT: pharmacometrics & systems pharmacology · 2025Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 4 countries.
Funding
Abstract
In 2019, stride velocity 95th centile (SV95C) became the first wearable-derived digital clinical outcome assessment (COA) qualified by the European Medicines Agency (EMA) for use as a secondary endpoint in trials for Duchenne muscular dystrophy. SV95C was approved via the EMA's qualification pathway for novel methodologies for medicine development, which is a voluntary procedure for assessing the regulatory acceptability of innovative methods used in pharmaceutical research and development. SV95C is an objective, real-world digital ambulation measure of peak performance, representing the speed of the fastest strides taken by the wearer over a recording period of 180 hours. SV95C is correlated with traditional clinic-based assessments of motor function and has greater sensitivity to clinical change over 6 months than other wearable-derived stride variables, for example, median stride length or velocity. SV95C overcomes many limitations of episodic, clinic-based motor function testing, allowing the assessment of ambulation ability between clinic visits and under free-living conditions. Here we highlight considerations and challenges in developing SV95C using evidence generated by a high-performance wearable sensor. We also provide a commentary of the device's technical capabilities, which were a determining factor in the regulatory approval of SV95C. This article aims to provide insights into the methods employed, and the challenges faced, during the regulatory approval process for researchers developing new digital tools for patients with diseases that affect motor function.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.