RecruitingNot ApplicableNCT06562283

Evaluation of the Reproducibility of a Fatigability Test Fitted to Patients With Spinal Muscular Atrophy


Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Enrollment

80 participants

Start Date

Dec 6, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Spinal muscular atrophy (SMA) is an autosomal recessive neuromuscular disease caused by the degeneration of motor neurons in the anterior horn of the spinal cord, due to the absence of the SMN1 gene and the resulting lack of SMN protein. Some patients with particularly severe forms (types 0 or 1) die before the age of 2 in the absence of treatment, while others retain autonomous walking throughout their lives, with no reduction in life expectancy. Three treatments aimed at restoring SMN (TRS) protein expression have recently been approved by the US Food and Drug Administration and the European Medicines Agency (i.e. Nusinersen / Onasemnogene Abeparvovec / Risdiplam). Patients treated with TRS after the onset of symptoms (symptomatic patients) may show significant motor improvement, but retain difficulties such as muscle weakness and fatigue leading to limitations in activities of daily living. The aim of this study is to adapt a fatigability test, widely validated in its original version in different populations (QIF test), but adapted in this protocol to the motor level and low abilities of certain SMA patients. Our objectives are to determine whether these assessments are feasible in SMA patients, reproducible, and relevant for monitoring this population, either routinely or for future clinical trials.


Eligibility

Min Age: 6 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Grip test, Quadriceps Intermittent Fatigue test (QIF test)), and others for people with infantile spinal muscular atrophy, juvenile spinal muscular atrophy, and other related conditions. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 6 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERThumb test

Thumb adduction test consisting of intermittent, repetitive isometric contractions lasting 5 seconds at incremental percentages of maximum force.

OTHERGrip test

Muscle contraction gripping test, consisting of intermittent, repetitive isometric contractions lasting 5 seconds at incremental percentages of maximum force.

OTHERQuadriceps Intermittent Fatigue test (QIF test))

Quadriceps muscle contraction test consisting of intermittent, repetitive isometric contractions lasting 5 seconds at incremental percentages of maximum force.


Locations(4)

Unités de Myologie et de Médecine du Sport

Saint-Etienne, France, France

HCL - Hôpital Croix Rousse

Lyon, France

HFME - Hospices Civils de Lyon

Lyon, France

Aphp - Hopital Pitie Salpetriere

Paris, France

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NCT06562283


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