This trial is active, not recruiting.

Condition healthy
Treatment load carriage
Sponsor Sheba Medical Center
Collaborator Tel Aviv University
Start date January 2015
End date December 2016
Trial size 12 participants
Trial identifier NCT02337998, 1593-14-SMC


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose prevention
each individual will serve as his own control by comparing baseline values to post intervention values
load carriage

Primary Outcomes

Neural performance of upper limb as measured by light touch sensitivity treshold
time frame: 1 hour
Neural performance of upper limb as measured by Thermal sensation treshold
time frame: 1 hour
Vascular performance of upper limb as measured by photoplethysmography of the index finger
time frame: 1 hour

Secondary Outcomes

Motor function of upper limb as measured by force application of the index finger
time frame: 1 hour

Eligibility Criteria

Male participants from 18 years up to 35 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Sheba Medical Center.