This report reviews a completed clinical trial entry testing inspiratory muscle training and manual therapy for neuromuscular disease and highlights potential regulatory considerations for device classification.
The ClinicalTrials.gov record lists conditions as Neuromuscular Disease and interventions including inspiratory muscle training, manual therapy and a conventional physiotherapy programme. The sponsor is Istinye University and the study status is Completed. The record reference is NCT07416929 and the public link appears below. The record shows a timestamp of 2026 02 19.
What changed for device evaluation in neuromuscular related trials?
The listing shows a trial framework that combines inspiratory muscle training and manual therapy with a conventional physiotherapy program. While the entry is not a completed device evaluation, the combination of non pharmacological interventions in a registered trial may influence how future studies are categorized for regulatory purposes. Observers should track how such trials are labeled in regulatory submissions and how outcomes are reported when devices are involved.
What are the trial components?
Interventions listed include inspiratory muscle training and manual therapy along with a conventional physiotherapy programme. The entry identifies Istinye University as sponsor and notes the status Completed. No efficacy results are provided in this record.
Trial details and sponsor information
Key details from the record include the conditions Neuromuscular Disease and the interventions listed. The sponsor is Istinye University. The status is Completed, indicating the record no longer shows ongoing activity for this entry. The public access link is provided below for reference.
Regulatory implications for neuromuscular trial interventions
Regulators may consider how non pharmacological interventions are described in trial records when device related claims or devices enter the clinical workflow. This entry underscores the need for clear statements of intended use and safety considerations for any device related component that may be used for inspiratory training or manual therapy in neuromuscular populations.
Who is affected by this information?
Researchers and trial sponsors will want to monitor how such interventions are registered and reported. Manufacturers providing inspiratory muscle training devices or manual therapy tools should note how trials describe use cases and outcomes. Regulatory teams can use this record to inform classification questions and future submissions.
FAQ
- 1. What is the status of this trial?
The record indicates Completed status on ClinicalTrials.gov. - 2. What interventions are listed in the trial?
The interventions include inspiratory muscle training, manual therapy and a conventional physiotherapy program.
Conclusion and implications
This record signals a focus on non pharmacological methods in neuromuscular disease research. Stakeholders should monitor how such interventions are described and regulated, and how future submissions may reference device related components used in respiratory or manual therapy contexts.
Disclaimer: This article is for professional informational purposes only. It is not legal advice. Consult MDR guidance and regulatory counsel for decisions about device submissions.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07416929?term=medical+device