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

I

IRCCS Eugenio Medea

Status

Enrolling

Conditions

Charcot Marie Tooth Disease
Spinal Muscular Atrophy (SMA)
Muscular Dystrophies
Myopathies

Treatments

Other: inapplicable

Study type

Observational

Funder types

Other

Identifiers

NCT06666816
RC 2024-2026 to E. Biffi (Other Grant/Funding Number)
GIP1112

Details and patient eligibility

About

This study has the general objective of observing walking parameters during a clinical test to objectively estimate fatigue in patients with neuromuscular diseases. Furthermore, the investigators want to evaluate the feasibility of collecting physical activity in daily life conditions during a one-week monitoring period using a wearable sensor.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

120 participants in 2 patient groups

Group with neuromuscular disease
Treatment:
Other: inapplicable
Control Group
Treatment:
Other: inapplicable

Trial contacts and locations

2

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Central trial contact

Fabio A Storm, PhD; Emilia Biffi, PhD

Data sourced from clinicaltrials.gov

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