Observational Study to Observe Variations of Gait Parameters 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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06666816

Enrollment

120

Registered

2024-10-31

Start date

2017-10-27

Completion date

2026-12-01

Last updated

2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Interventions

OTHERinapplicable

inapplicable

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Subjective fatigue	Baseline	Evaluation of subjective fatigue using the Fatigue Severity Scale (FSS). The minimum value is 0, the maximum is 63. Higher scores mean worse outcome.
Variation in walking speed during a 6-minutes walking test	Baseline	Variation in walking speed calculated as difference between the first and the final minute of the a 6-minutes walking test

Secondary

Measure	Time frame	Description
Clinical progression of the neuromuscular disease	Baseline	Progression of the neuromuscular disease using the Motor Function Measure-32 (MFM-32); the minimum score is 0, the maximum score is 100. Higher values mean better outcome.
Variation in gait variability during the 6-Minutes Walking Test	Baseline	Variation of step duration during the 6MWT extracted from a wearable inertial sensor. Measured in coefficient of variation (%). Higher values mean worse outcome.

Countries

Italy

Contacts

CONTACTFabio A Storm, PhD

fabio.storm@lanostrafamiglia.it+39031877111

CONTACTEmilia Biffi, PhD

emilia.biffi@lanostrafamiglia.it+39031877111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026