Mechanical Load on the Shoulders While Carrying a Backpack- Towards a Knowledge-Based Backpack Design
Recruitment status was Not yet recruiting
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | February 3, 2010 | ||||||||
| Last Updated Date | February 9, 2010 | ||||||||
| Start Date ICMJE | February 2010 | ||||||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01066975 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Mechanical Load on the Shoulders While Carrying a Backpack- Towards a Knowledge-Based Backpack Design | ||||||||
| Official Title ICMJE | Mechanical Load on the Shoulders While Carrying a Backpack- Towards a Knowledge-Based Backpack Design | ||||||||
| 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
Volunteers Five young (18-30 yrs), healthy, and fit males will participate in this study. Trials design
The maximal total participation time of each volunteer will be 2 hours total (inside and outside the MR). Data acquired in the current trials will be used for the development of a FE (finite element) 3D shoulder model. MR scans will be utilized for composing geometry and for the boundary conditions assessment (strain magnitude). Pressure measurements will be used as boundary conditions (stress magnitude). MR scans and pressure measurements will be performed in the Sheba medical center facilities. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | young and fit
5 healthy subjects, age lower than 30 yrs and high physical fitness |
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 5 | ||||||||
| Estimated Completion Date | April 2011 | ||||||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Male | ||||||||
| Ages | 18 Years to 30 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Israel | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01066975 | ||||||||
| Other Study ID Numbers ICMJE | SHEBA-10-7645-NS-CTIL | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Nogah Shabshin, Sheba Medical Center | ||||||||
| Study Sponsor ICMJE | Sheba Medical Center | ||||||||
| Collaborators ICMJE | Tel Aviv University | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Sheba Medical Center | ||||||||
| Verification Date | February 2010 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||