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临床试验/NCT02337998
NCT02337998已完成不适用

The Effect of Load Carriage on Upper Limb Performance

Sheba Medical Center0 个研究点目标入组 10 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
主要终点
Neural performance of upper limb as measured by light touch sensitivity treshold

研究概览

简要总结

Purpose: Quantify the relationship between brachial plexus deformations caused by backpack carriage and upper extremity performance.

Significance of expected results:

The study will allow to quantify the effect of load carriage on both neural and vascular function parameters.

Study plan The effect of nerve strain on neural function: based on the strains obtained for each load from computational simulation, and from animal studies published in the literature, the expected neural function, (e.g., motor and sensory) dysfunction will be estimated.

Following signing an informed consent form, 12 young adult subjects (18-35 years) will don a military backpack loaded with 25-40 kg. Each volunteer will undergo the following test at baseline, following 45 min exposure, and following 15 min of recovery:

  1. Index finger microvascular flow will be measured by photoplethysmography (PPG).
  2. Sensory measurement at the finger; Light touch threshold will be measured by mechanical stimulation that will be applied using Von Frey Filaments of the Semmes-Weinstein Monofilament (SWM) type.
  3. Forearm thermal sensation threshold; As a measure of sensory function in the forearm, cold and warm sensation thresholds will be measured with a computerized quantitative thermal sensory device.

Immediately following the 45 min loading exposure, the fine motor function of the index finger will be tested by the following procedures (in an unloaded condition): 4. Index finger motor function; Force application profile during a trigger press will be measured using a force sensor located on a trigger of a dummy weapon simulator. Force application rate, peak force, and press-to-press peak force variability will be measured based on 10 trigger presses. 5. Accuracy of force application; Will be evaluated by the simulated shot accuracy, horizontal displacement (X) and vertical displacement (Y). 6. Subjective parameters; in all time points, the volunteers will be asked to rate their level of pain sensation intensity (VAS sensory) and degree of unpleasantness (VAS affective) in the shoulders and other load bearing sites, as well as ratings of perceived exertion (RPE). All subjective parameters will be assessed using visual analogue scales.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Healthy medical status, fit (regular physical activity > 3 times weekly) men Previous experience with heavy backpack carriage Age: 18-35

排除标准

  • Heavy load carrying activity in the past 48 hr
  • Known diseases or medical conditions that may interfere with the study, of:
  • Musculoskeletal system Nervous system Cardiovascular system Vascular disease

结局指标

主要结局

Neural performance of upper limb as measured by light touch sensitivity treshold

时间窗: 1 hour

Neural performance of upper limb as measured by Thermal sensation treshold

时间窗: 1 hour

Vascular performance of upper limb as measured by photoplethysmography of the index finger

时间窗: 1 hour

次要结局

  • Motor function of upper limb as measured by force application of the index finger(1 hour)

研究者

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

Dr. Gabriel Zeilig

Director, Department of Neurological Rehabilitation

Sheba Medical Center

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