Observational Study to Observe Variations of Gait Parameters in Patients With Neuromuscular Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorIRCCS Eugenio Medea
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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 population
Potentially eligible participants will be selected from clinical databases of IRCCS Medea
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
inapplicable
Other interventioninapplicable
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Group with neuromuscular disease1 intervention
Group B: Control Group1 intervention
Trial outcomes
Primary outcomes
1
Variation in walking speed during a 6-minutes walking test
Variation in walking speed calculated as difference between the first and the final minute of the a 6-minutes walking test
Time frame
Baseline2
Subjective fatigue
Evaluation of subjective fatigue using the Fatigue Severity Scale (FSS). The minimum value is 0, the maximum is 63. Higher scores mean worse outcome.
Time frame
BaselineSecondary outcomes
1
Clinical progression of the neuromuscular disease
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.
Time frame
Baseline2
Clinical progression of the neuromuscular disease
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.
Time frame
Baseline3
Variation in gait variability during the 6-Minutes Walking Test
Variation of step duration during the 6MWT extracted from a wearable inertial sensor. Measured in coefficient of variation (%). Higher values mean worse outcome.
Time frame
BaselineOther outcomes
1
Acceptability of the activity monitoring device during daily life
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.
Time frame
Baseline2
User friendliness of the activity monitoring device during daily life
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.
Time frame
Baseline3
Physical activity in daily life
Steps/day measured using a wearable inertial sensor. Higher values mean better outcome.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov