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/Actively Recruiting
Led by IRCCS Eugenio Medea · Updated on 2026-01-20
120
Participants Needed
2
Research Sites
N/A
Total Duration
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
Observational Study to Observe Variations of Gait Parameters in Patients With Neuromuscular Diseases
F
Fabio A Storm, PhD
E
Emilia Biffi, PhD
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IRCCS Eugenio Medea
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo clinical tests to assess gait parameters and fatigue levels.
1 visit (in-person)
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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/29715279/IRCCS Eugenio Medea
Lead Sponsor