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The Effect of Custom-Made Biomechanical Perturbation Platform on Kinetics, Kinematics and Electromyography in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00476333
Recruitment Status : Unknown
Verified April 2007 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : May 22, 2007
Last Update Posted : May 22, 2007
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center

Tracking Information
First Submitted Date  ICMJE May 19, 2007
First Posted Date  ICMJE May 22, 2007
Last Update Posted Date May 22, 2007
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Custom-Made Biomechanical Perturbation Platform on Kinetics, Kinematics and Electromyography in Healthy Subjects
Official Title  ICMJE Not Provided
Brief Summary

Introduction: Kinetic, kinematic and electromyographic activity of the lower limb have been shown to be influenced by various footwear-generated biomechanical manipulations (e.g. soles. Insoles, orthoses). A novel biomechanical device comprising four modular elements attached onto foot-worn platforms was recently developed. Each element can be individually calibrated (Position, convexity, height and resilience) to induce a specific biomechanical challenge.

Objectives: The aim of this study is to evaluate the influence of specific biomechanical challenges on Kinetics, kinematics and electromyographic activity of the lower limb.

Design: Prospective, case control Setting: Motion analyses will be conducted during level walking with (1) a three-dimensional motion analysis system and (2) ground reaction force analysis using force platforms (3) Electro-Myography system. Each subject will be examined in 16 different settings of the biomechanical system

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Device: APOS biomechanical gait system
Study Arms  ICMJE Not Provided
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 Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy
  • Similar anthorpometric profile (i.e. weight, shoe size, height, dominant leg)

Exclusion Criteria:

  • Previous orthopedic, musculosceletal or neurological pathology
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00476333
Other Study ID Numbers  ICMJE 70/07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Assaf-Harofeh Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nahum Halperin, MD Asaf-Harofeh Medical Center
PRS Account Assaf-Harofeh Medical Center
Verification Date April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP