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NCT Number: NCT06666816

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

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.

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Key information

Conditions

Muscular Dystrophies Central Nervous System Diseases Charcot Marie Tooth Disease Charcot-Marie-Tooth Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Sensory and Motor Neuropathy Heredodegenerative Disorders, Nervous System Motor Neuron Disease Muscular Atrophy, Spinal Muscular Diseases Muscular Disorders, Atrophic Musculoskeletal Diseases Myopathies Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Polyneuropathies Spinal Cord Diseases Spinal Muscular Atrophy (SMA)

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Scientific Institute IRCCS E. Medea - Sede di Bosisio Parini, Bosisio Parini, Lecco, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

inapplicable

Other

inapplicable

Primary outcomes

  1. Variation in walking speed during a 6-minutes walking test

    Time frame: Baseline

    Variation in walking speed calculated as difference between the first and the final minute of the a 6-minutes walking test

  2. Subjective fatigue

    Time frame: 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.

Secondary outcomes

  1. Clinical progression of the neuromuscular disease

    Time frame: 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.

  2. Clinical progression of the neuromuscular disease

    Time frame: Baseline

    Progression of the neuromuscular disease using the Hammersmith Functional Motor Scale- Expanded (HFMS-E); the minimum value is 0, the maximum value is 69. Higher values mean better outcome.

  3. Variation in gait variability during the 6-Minutes Walking Test

    Time frame: Baseline

    Variation of step duration during the 6MWT extracted from a wearable inertial sensor. Measured in coefficient of variation (%). Higher values mean worse outcome.

Other outcomes

  1. Acceptability of the activity monitoring device during daily life

    Time frame: Baseline

    Acceptability of the device during activity monitoring in daily life using the Comfort Rating Scale (CRS). Minimum value is 0, maximum value is 20. Higher values mean lower acceptability.

  2. User friendliness of the activity monitoring device during daily life

    Time frame: Baseline

    User friendliness of the device during activity monitoring in daily life using the Questionnaire on User Friendliness of Activity Monitors (QUFAM). Maximum value is 5, minimum value is 0. Higher values mean higher acceptability.

  3. Physical activity in daily life

    Time frame: Baseline

    Steps/day measured using a wearable inertial sensor. Higher values mean better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Emilia Biffi, PhD

CONTACT

[email protected]

+39031877111

Fabio A Storm, PhD

CONTACT

[email protected]

+39031877111

Sponsors and collaborators

Lead sponsor

IRCCS Eugenio Medea

Other

Registry information

Official study title

Observational Study for the Identification of Fatigue and Gait Biomarkers in Populations With Neuromuscular Pathologies in the Clinical Context and Daily Life

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Oct 31, 2024
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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