NCT04772027|Unknown
Motor Parameters in Patients With Limb Girdle Muscular Dystrophy
EIDY
Characterization and Identification of Motor Parameters Using Instrumental Assessment in Patients With Limb Girdle Muscular Dystrophy
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EIDY
Characterization and Identification of Motor Parameters Using Instrumental Assessment in Patients With Limb Girdle Muscular Dystrophy
Sponsor study identifier
Secondary identifiers
REGISTRY · IDRCB
observational
80
1 country
1
Study Start
April 1, 2021
Actual (reported)Primary Completion
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The primary objective of the study is to perform 2-year follow up with motor parameters evolution using instrumental assessments in patients with limb girdle muscular dystrophie, and to identify which motor parameters are sensitive to change. The secondary objectives of the study are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 7, 2021
Actual (reported)February 25, 2021
Actual (reported)April 1, 2021
Actual (reported)January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change from baseline on maximal strength
Maximal strength and muscular activation of knee extensors will be evaluated by isometric test with an isokinetic dynamometer (Biodex Medical Systems Inc., Shirley, New York, USA).
Assessed at 6 months, 12 months, 18 months and 24 months
Change from baseline on peak hip flexion
Hip flexion peak during gait will be evaluated with tridimensional gait analysis with an optoelectronic system ((Optitrack system, Natural Point Inc. Corvallis, OR, USA)
Assessed at 6 months, 12 months, 18 months and 24 months
Change from baseline on speed of center of pression during standing postural control
Speed of center of pression will be measured by force platforms (AMTI, Advanced Mechanical Technology).
Assessed at 6 months, 12 months, 18 months and 24 months
Change from baseline on elbow peak extension during upper limb spatial exploration
Elbow peak extension will be measured biomechanically with an optoelectronic system during upper limb spatial exploration (Optitrack system, Natural Point Inc. Corvallis, OR, USA)
Assessed at 6 months, 12 months, 18 months and 24 months
Change from baseline on muscular parameters
Assessed at 6 months, 12 months, 18 months and 24 months
Joint kinematic parameters: change from baseline on gait speed
Assessed at 6 months, 12 months, 18 months and 24 months
Joint kinematic parameters: change from baseline on step length
Assessed at 6 months, 12 months, 18 months and 24 months
Joint kinematic parameters: change from baseline on cadence
Assessed at 6 months, 12 months, 18 months and 24 months
Joint kinematic parameters: change from baseline on step width
Assessed at 6 months, 12 months, 18 months and 24 months
40 patients with limb girdle muscular dystrophie
40 healthy volunteers without neuromuscular or squeletic disorder
Population with limb girdle muscular dystrophie for 2-year longitudinal follow-up in Raymond Poincaré hospital. The 4 most common types of diseases: calpainopathy, sarcoglycanopathy, dysferlinopathy and alpha-dystroglycanopathy. Control group: healthy population without neuromuscular or squeletic disorder.
Laboratoire d'analyse du mouvement, Service d'exploration fonctionnelles, Hôpital Raymond Poincaré, APHP
Garche, 92380, France
Céline BONNYAUD, PhD
Laboratoire d'analyse du mouvement, Service d'explorations fonctionnelles, Hôpital Raymond Poincaré, APHP
Samuel POUPLIN
Plateforme Nouvelles Technologies, Hôpital Raymond Poincaré, APHP
First Submitted
January 7, 2021
First Posted
February 25, 2021
Study Start
April 1, 2021
Actual (reported)Primary Completion
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 6, 2023
Record last verified: 2023-09
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Source: ClinicalTrials.gov.
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