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临床试验/NCT07381920
NCT07381920暂停不适用

Effects of Muscle Cooling on Motor Unit Firing of the Quadriceps: A Pilot Feasibility Study

Wake Forest University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年1月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
暂停
入组人数
24
试验地点
2
主要终点
Motor Unit (MU) Yield

研究概览

简要总结

The overall objective of this pilot study is to establish the feasibility and methodological validity of using high-density surface electromyography to characterize motor unit behavior of the quadriceps under thermoneutral and locally cooled conditions, and to generate preliminary data to inform the design of a larger, hypothesis-driven study.

详细描述

This randomized, cross-over pilot study will recruit 24 healthy young adults (12 men and 12 women) between the ages of 18 and 35 years. Participants will attend two in-person laboratory visits separated by a minimum of 48 hours. Visit 1 will include informed consent, eligibility confirmation, baseline assessments, and familiarization procedures. Visit 2 will include experimental testing under thermoneutral and cooled conditions.

研究设计

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

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women between the ages of 18 and 35 years
  • Healthy adults, defined as absence of significant acute/chronic medical condition, injury, and/or illness that may compromise subject safety, limit the ability of the participant to complete the study, and/or compromise the objectives of the study as determined by the Principal Investigator.

排除标准

  • Current diagnosis or history of:
  • major metabolic disease (e.g., type I and type II diabetes),
  • neuromuscular disease (e.g., cervical spondylotic radiculomyelopathy, lumbar spondylosis, amyotrophic lateral sclerosis, Guillain-Barré syndrome, and acquired demyelinating polyneuropathies),
  • cardiovascular disease (e.g., stage II hypertension, heart failure, myocardial infarction/ischemia, peripheral vascular disease, Raynaud's phenomenon, or other conditions associated with impaired peripheral circulation),
  • significant myocardial or pericardial diseases (e.g. amyloidosis, constriction),
  • moderate or severe valvular disease,
  • pulmonary/respiratory disease (e.g., asthma, chronic bronchitis, emphysema, chronic obstructive pulmonary disease),
  • renal disease,
  • liver disease,
  • or anemia.
  • Current or recent musculoskeletal injury (e.g. fracture, sprain, dislocation) or any physical disability that precludes safe and adequate testing.
  • Pregnancy or breastfeeding.
  • Thigh circumference greater than 23 inches
  • Mid-thigh skinfold thickness greater 40 mm

研究组 & 干预措施

Sequence A

Experimental

Those randomized to Group A (n=12, 50% men) will perform the thermoneutral condition first, followed by the cooled condition.

干预措施: Cryotherapy (Procedure)

Sequence B

Experimental

Those randomized to Group B (n=12, 50% men) will perform the cooled condition first, followed by the thermoneutral condition.

干预措施: Cryotherapy (Procedure)

结局指标

主要结局

Motor Unit (MU) Yield

时间窗: Immediately after the intervention

Number of unique motor units successfully identified (decomposed) from quadriceps HDsEMG recordings during maximal voluntary contractions (MVCs) under thermoneutral and cooled conditions.

HDsEMG Decomposition Accuracy

时间窗: Immediately after the intervention

Quality/accuracy of motor unit decomposition from quadriceps HDsEMG recorded during MVCs under thermoneutral and cooled conditions, based on decomposition quality metrics generated by the Delsys Neuromap Precision Decomposition III algorithm.

Proportion of Analyzable MVC Trials

时间窗: Immediately after the intervention

Percentage of MVC trials that yield HDsEMG data suitable for motor unit decomposition and analysis under thermoneutral and cooled conditions (successful decomposition and acceptable signal quality).

次要结局

  • Slope of MUAP-FR relationship(Immediately after the intervention)
  • Y-intercept of MUAP-FR relationship(Immediately after the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eliott Arroyo

Assistant Professor

Wake Forest University

研究点 (2)

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