DT4RD

• Research type

  Research Study

• Full title

  Feasibility, validation and application of digital tools for the follow-up of neuromuscular patient mobility in daily living.

• IRAS ID

  331474

• Contact name

  Volker Straub

• Contact email

  volker.straub@newcastle.ac.uk

• Sponsor organisation

  Association Institut de Myologie

• Clinicaltrials.gov Identifier

  NCT05798325

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  The main goal of the study is to assess motor function in patients with neuromuscular diseases by remote monitoring of activities of daily living with digital tools that capture movement. The main clinical symptom of patients with neuromuscular diseases is muscle weakness and a decline in muscle function over time.
  This feasibility/pilot study will test if these tools are practical and beneficial, and if the results they provide are comparable to validated motor function assessments carried out by trained physiotherapists in a hospital setting. The study plan is to put together a set of assessments that focus on different aspects of motor function such as mobility, strength, range of motion, fatigue, lung function, pain, heart health, balance, coordination, falls, and tremor. The DT4RD study will involve 40 participants from 12 to 60 years of age who have been diagnosed with genetic neuromuscular disorders. To develop and validate a set of non-invasive digital tools, the study will measure and compare the mobility of patients using a sensor/wearable device connected to a mobile phone application. The participants will be fully informed about any potential discomfort or side effects that may arise due to physical pressure from the wearable device. We hypothesise that the remote measurements of motor function taken at home will be as informative and meaningful as the standardised physiotherapy assessments in a hospital setting. If this is the case, it would have direct implications for patient care, as remote assessments of activities of daily living are potentially less tiring and stressful for patients, may reduce the burden of travelling to a hospital, and reflect real-life situations. If we can show that digital tools are capturing motor function reliably, they could eventually be used in clinical trials for patients with movement disorders more generally.

• REC name

  East Midlands - Nottingham 1 Research Ethics Committee

• REC reference

  23/EM/0187

• Date of REC Opinion

  25 Sep 2023

• REC opinion

  Further Information Favourable Opinion