Mechanical Load on the Shoulders While Carrying a Backpack- Towards a Knowledge-Based Backpack Design

NCT01066975 | Unknown

• 1 other identifier: SHEBA-10-7645-NS-CTIL
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Soldiers and recreational backpackers are often required to carry heavy loads on their body during military operations or hiking. Despite the advances in backpack design, the loads carried by soldiers still impose an extreme physiological strain (soft tissue deformation) which frequently results in discomfort, pain,musculoskeletal injuries, and loss sensorimotor function. In the current study, characterization of the pressures, evaluation of the deformations of the soft tissues, specifically the fat, muscles, Brachial plexus and subclavian vessels applied on the shoulder while sitting with a heavy backpack will performed. The data acquired in the current trials will be used for development of a finite element (FE) 3D shoulder model. The purpose is to better understand the mechanical loads that are being transferred to the underlying tissue below the shoulder straps during walking/marching with a backpack. During the 2nd phase of this project, data collected during this research will be used to develop gear that will alleviate the strain on the shoulders, prevent injury, and enhance performance. Hypothesis

• High focal strain (hot-spots) on the shoulder tissue that are observed with the pressure mapping will be observed also in the MR scans.
• The strain at those hot-spots can be reduced by personal-geometry adjusted straps. Volunteers Five young (18-30 yrs), healthy, and fit males will participate in this study. Trials design
• MR Scans- The scan will be performed for analysis of personal shoulder anatomy, and will be used for developing a 3D FE model. The sagittal view will be used to develop the 3D model. The coronal and axial sectional views will be used to assess the deformations applied on the shoulder tissue. The scan will then be repeated while carrying a 25 kg standard commercial backpack while sitting in the same position, for the assessment of shoulder girdle tissues deformations. Time estimation for each scan is 40 min (80 min total). The subjects are not required to carry the backpack prior to those scans.
• Static pressure measurement- each volunteer will be asked to sit for 30 seconds while carrying the 25 kg backpack. During this session, pressure will be measured using a pressure mapping pad (Sensor Products Inc., USA) placed between the shoulder strap and the underlying tissue.

Conditions

Healthy; Strain

Keywords

loaded backpack; unloaded backpack

Study Arms (1)

young and fit

5 healthy subjects, age lower than 30 yrs and high physical fitness

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Five young (18-30 yrs), healthy, and fit males will participate in this study. Prior to signing a consent form, the PI will explain to the subjects about the MRI that they are about to participate in if they will decide to sign including all the discomforts involved in this study. For subjects that don't have contraindications for MRI there are no reported risks. The subjects will be informed that each one of them is free to decide, and is free to stop his participation any time he wishes to.

You may qualify if:

• yrs
• healthy
• fit
• males

You may not qualify if:

• contraindications for MRI

Sponsors & Collaborators

• Sheba Medical Center: lead
• Tel Aviv University: collaborator

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Amir Hadid, BSc

  Sheba Medical Center

  STUDY DIRECTOR

Central Study Contacts

Nogah Shabshin, MD

CONTACT

972 52 6666652; shabshin@gmail.com

Amir Hadid, BSc

CONTACT

972 57 8119887; amir.hadid@sheba.health.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 10, 2010
• Study Start: February 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: April 1, 2011
• Last Updated: February 10, 2010

Record last verified: 2010-02

Locations

IL (1)