HealthyNCT02337998
The Effect of Load Carriage on Upper Limb Performance
A study testing load carriage in people with Healthy, run by Sheba Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- load carriage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy medical status, fit (regular physical activity > 3 times weekly) men Previous experience with heavy backpack carriage Age: 18-35
Who cannot join
- 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
About this study
Purpose: Quantify the relationship between brachial plexus deformations caused by backpack carriage and upper extremity performance.
Significance of expected results:
Read more
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:
- Index finger microvascular flow will be measured by photoplethysmography (PPG).
- 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.
- 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):
- 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.
- Accuracy of force application; Will be evaluated by the simulated shot accuracy, horizontal displacement (X) and vertical displacement (Y).
- 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.
- Conditions
- Healthy
- Being tested
- load carriage
- Keywords
- Neurology, Sports Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
load carriageOther
| Study group | Role | What they receive |
|---|---|---|
| Healthy men | Experimental | each individual will serve as his own control by comparing baseline values to post intervention values Receives: Other: load carriage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural performance of upper limb as measured by light touch sensitivity treshold
Measured: 1 hour
Neural performance of upper limb as measured by Thermal sensation treshold
Measured: 1 hour
Vascular performance of upper limb as measured by photoplethysmography of the index finger
Measured: 1 hour
Secondary outcomes (1)
Motor function of upper limb as measured by force application of the index finger
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Tel Aviv University
- Responsible party
- Principal investigator, Dr. Gabriel Zeilig, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337998
- Sponsor's protocol ID
- 1593-14-SMC
- Status last verified
- May 2017
- First submitted
- 6 Jan 2015
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Load Carriage on Upper Limb Performance
- ClinicalTrials.gov ID
- NCT02337998
- Acronym / sponsor ID
- 1593-14-SMC
- Conditions
- Healthy
- Keywords
- Neurology, Sports Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Tel Aviv University
- Study start
- Jan 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 14 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Index finger microvascular flow will be measured by photoplethysmography (PPG).
- 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.
- 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):
- 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.
- Accuracy of force application; Will be evaluated by the simulated shot accuracy, horizontal displacement (X) and vertical displacement (Y).
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy men | Experimental | Other: load carriageeach individual will serve as his own control by comparing baseline values to post intervention values |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy medical status, fit (regular physical activity > 3 times weekly) men Previous experience with heavy backpack carriage Age: 18-35
Key exclusion criteria (3 listed)
- Heavy load carrying activity in the past 48 hr
- Musculoskeletal system Nervous system Cardiovascular system Vascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| load carriage | Other | Healthy men |
Primary outcome
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
1 secondary outcome
Motor function of upper limb as measured by force application of the index finger
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing load carriage in people with Healthy, run by Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural performance of upper limb as measured by light touch sensitivity treshold (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017.