Observing walking patterns in patients with neuromuscular diseases
Observational Study for the Identification of Fatigue and Gait Biomarkers in Populations With Neuromuscular Pathologies in the Clinical Context and Daily Life
This study is testing how walking patterns change in people with neuromuscular diseases and whether wearable sensors can help track their daily activity and fatigue levels.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | IRCCS Eugenio Medea Academic / other |
| Locations | 2 sites (Bosisio Parini, Lecco and 1 other locations) |
| Trial ID | NCT06666816 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess variations in gait parameters among patients with neuromuscular diseases, including muscular dystrophies, myopathies, spinal muscular atrophy, and Charcot-Marie-Tooth disease. The study will involve a clinical test to objectively measure fatigue during walking and will also evaluate the feasibility of using wearable sensors to monitor physical activity in daily life over a one-week period. By collecting this data, the researchers hope to gain insights into the impact of these conditions on mobility and daily functioning.
Who should consider this trial
Good fit: Ideal candidates include ambulant adult patients with a genetic diagnosis of muscular dystrophy, myopathy, spinal muscular atrophy, or Charcot-Marie-Tooth disease who can walk independently, even with assistance.
Not a fit: Patients with significant heart disease or chronic respiratory failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of gait and fatigue in neuromuscular diseases, potentially leading to improved management strategies for patients.
How similar studies have performed: While similar observational studies have been conducted, this specific approach focusing on gait parameters and daily activity monitoring in this patient population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ambulant adult patients with genetic diagnosis of muscular dystrophy/myopathy (dystrophinopathies, muscular dystrophies and congenital and non-congenital myopathies), of spinal muscular atrophy (SMA) and with molecular diagnosis of Charcot-Marie Tooth 1 or 2. * independent walking, even with assistance; Exclusion Criteria: * Dilated or ischemic heart disease with moderate impairment; * Chronic respiratory failure: forced vital capacity (FVC) \< 40%; more than 5% of nocturnal time spent with peripheral oxygen saturation levels \< 90.
Where this trial is running
Bosisio Parini, Lecco and 1 other locations
- Scientific Institute IRCCS E. Medea - Sede di Bosisio Parini — Bosisio Parini, Lecco, Italy (Recruiting)
- Scientific Institute IRCCS E. Medea - Polo di Conegliano — Conegliano, Treviso, Italy (Not_yet_recruiting)
Study contacts
- Study coordinator: Fabio A Storm, PhD
- Email: fabio.storm@lanostrafamiglia.it
- Phone: +39031877111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.