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RECRUITING
NCT06924125

Spanish Natural History Study for LAMA2 Muscular Dystrophy

Sponsor: Hospital Universitari Vall d'Hebron Research Institute

View on ClinicalTrials.gov

Summary

The objective of this natural history study is to comprehensively characterize the disease progression and clinical features of LAMA2-related dystrophies (LAMA2-RD) in the pediatric population. The study aims to establish a well-defined cohort of patients in Spain, enabling long-term follow-up and facilitating recruitment for future clinical trials.

Key Details

Gender

All

Age Range

0 Minutes - 100 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2021-07-27

Completion Date

2030-07-01

Last Updated

2025-04-11

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Motor function scales

Evaluation of patients motor function using motor scales (MFM32, CHOP)

DIAGNOSTIC_TEST

MUSCLE ULTRASOUND

Ultrasound guided evaluation of 28 muscles evaluated accross different body regions, assessed using the Heckmatt gradinf system (semiquantitative scale).

DIAGNOSTIC_TEST

Muscle Elastography

Assess the mechanical properties of muscles, such as stiffness and elasticity.

OTHER

Complete physical examination

Complete physical evaluations including muscle power and goniometry measurements

OTHER

Ventilatory/ respiratory and other support assessment

Assessment of ventilatory, respiratory, and other support needs to evaluate the necessity of assistive devices

OTHER

Oromotor function and nutrition

Assessment of bulbar funcionality: feeding devices, nutritional status.

OTHER

Motor Milestone Assessments

Motor milestones age of acquisition and loss

Locations (1)

University Hospital Vall d'Hebron

Barcelona, Barcelona, Spain