NCT Number: NCT02337998
The Effect of Load Carriage on Upper Limb Performance
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.
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Notify MeKey information
Conditions
Age range
18 year–35 year
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
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
Sponsors and collaborators
Lead sponsor
Sheba Medical Center
Other Gov
Collaborators
- Tel Aviv University
Registry information
Important dates
- Study start
- 2015
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Jan 14, 2015
- Registry last updated
- May 2, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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