NCT06666816
Recruiting
Not Applicable
Observational Study for the Identification of Fatigue and Gait Biomarkers in Populations With Neuromuscular Pathologies in the Clinical Context and Daily Life
IRCCS Eugenio Medea2 sites in 1 country120 target enrollmentOctober 27, 2017
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Muscular Dystrophies
- Sponsor
- IRCCS Eugenio Medea
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Variation in walking speed during a 6-minutes walking test
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
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.
Investigators
Eligibility Criteria
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
- •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.
Outcomes
Primary Outcomes
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
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
- Clinical progression of the neuromuscular disease(Baseline)
- Variation in gait variability during the 6-Minutes Walking Test(Baseline)
Study Sites (2)
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