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临床试验/NCT06562283
NCT06562283招募中不适用

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

Centre Hospitalier Universitaire de Saint Etienne5 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年12月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
5
主要终点
Feasibility of a fatigability test adapted to the motor level of the entire population of patients with spinal muscular atrophy.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
6 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Genetically confirmed spinal muscular atrophy
  • Age ≥ 6 years
  • No orthopaedic surgery in the 6 months prior to inclusion
  • Informed consent signed by the patient(s) or parent(s)/legal guardian(s) and assent of the patient
  • Affiliated or beneficiary of a health insurance scheme (for inclusion in France)

排除标准

  • Other condition that may significantly interfere with the assessment of the SMA and which is clearly unrelated to the disease
  • Other associated neurological disease
  • Joint deformities that prevent correct and comfortable positioning with the various different measuring devices (thumb-index clamp, handgrip and QIF-test)
  • Contraindication to transcranial magnetic stimulation

研究组 & 干预措施

Ambulatory patients (SMA-AMB)

Experimental

The patient is said to be "ambulant" if he or she is able to walk and perform a muscle contraction test with the quadriceps.

干预措施: Grip test (Other)

Non-ambulatory patients without grasping ability (SMA-POU)

Experimental

The patient is said to be "non-ambulant", with the ability to contract the thumb, but without the ability to grasp the hand.

干预措施: Thumb test (Other)

Ambulatory patients (SMA-AMB)

Experimental

The patient is said to be "ambulant" if he or she is able to walk and perform a muscle contraction test with the quadriceps.

干预措施: Quadriceps Intermittent Fatigue test (QIF test)) (Other)

Non-ambulatory patients capable of effective grasping (SMA-PRE)

Experimental

The patient is said to be "non-ambulant", with the ability to grasp the hand.

干预措施: Thumb test (Other)

Non-ambulatory patients capable of effective grasping (SMA-PRE)

Experimental

The patient is said to be "non-ambulant", with the ability to grasp the hand.

干预措施: Grip test (Other)

结局指标

主要结局

Feasibility of a fatigability test adapted to the motor level of the entire population of patients with spinal muscular atrophy.

时间窗: Day : 1

Feasibility will be assessed by the patient's success in performing the fatigability test: i.e. performing at least 2 incremental steps (i.e. at least 10 contractions at 10% of their maximum strength, then 10 contractions at 20% of their maximum strength). Validation of the feasibility of the fatigability test will be obtained if at least 80% of patients are able to perform at least the first 2 stages.

次要结局

  • Tolerance of fatigability test - Pain(Day : 1)
  • Tolerance of fatigability test - RPE(Day : 1)
  • Tolerance of fatigability test - AEs(Day : 1)
  • Reproducibility of the fatigability test(Day : 1)
  • Reproducibility of the central and peripheral components of fatigue - VA(Day : 1)
  • Reproducibility of the central and peripheral components of fatigue - magnetic jerk(Day : 1)
  • Perceived fatigue - FACIT-F(Day : 1)
  • Perceived fatigue - PedsQL 4.0(Day : 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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