Actively Recruiting

Age: 18Years - 75Years
All Genders
Healthy Volunteers
ID06666816

Observational Study for the Identification of Fatigue and Gait Biomarkers in Neuromuscular Diseases During Clinical Tests and Daily Life Monitoring

Led by IRCCS Eugenio Medea · Updated on 2026-01-20

120

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are observing walking patterns and fatigue in adults with neuromuscular diseases such as muscular dystrophies, myopathies, spinal muscular atrophy, and Charcot-Marie Tooth disease. The study aims to objectively measure fatigue through clinical walking tests and to explore how feasible it is to collect physical activity data during daily life using wearable sensors over a one-week period. Participants include adults aged 18 to 75 who can walk independently, with or without assistance. The study involves observing walking speed variability during a six-minute walking test and monitoring physical activity in everyday settings using wearable devices. Both patients with neuromuscular diseases and a control group are included for comparison. During the study, participants will undergo a six-minute walking test to assess changes in walking speed and gait variability. Subjective fatigue levels and clinical progression of their neuromuscular condition will also be recorded. Physical activity will be monitored for one week with wearable sensors to gather data on daily life movements. The study includes healthy volunteers and runs until December 2026.

CONDITIONS

Brief Title

Observational Study to Observe Variations of Gait Parameters in Patients With Neuromuscular Diseases

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged 18 to 75 with a genetic diagnosis of muscular dystrophy, myopathy, spinal muscular atrophy, or Charcot-Marie Tooth disease
  • Able to walk independently, with or without assistance
Not Eligible

You will not qualify if you...

  • Moderate dilated or ischemic heart disease
  • Chronic respiratory failure with forced vital capacity less than 40%
  • Spending more than 5% of the night with oxygen saturation below 90%

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo clinical tests to assess gait parameters and fatigue levels.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 6 months

Participants are observed during daily life to monitor variations in gait and fatigue over time.

Periodic assessments depending on participant availability

Trial Site Locations

Total: 2 locations

1

Scientific Institute IRCCS E. Medea - Sede di Bosisio Parini

Bosisio Parini, Lecco, Italy, 23842

Actively Recruiting

2

Scientific Institute IRCCS E. Medea - Polo di Conegliano

Conegliano, Treviso, Italy, 31015

Not Yet Recruiting

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Research Team

F

Fabio A Storm, PhD

E

Emilia Biffi, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Connecting real-world digital mobility assessment to clinical outcomes for regulatory and clinical endorsement-the Mobilise-D study protocol.

A Stefanie Mikolaizak, Lynn Rochester, Walter Maetzler...

https://pubmed.ncbi.nlm.nih.gov/36201476