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Completed

NCT Number: NCT02299674

Study of Medial-Lateral Center of Pressure Displacement in Unilateral Transfemoral Amputees

The purpose of this study is to examine the path and velocity of the center of mass (CoM) and center of pressure (CoP) during double support of persons walking with a unilateral above-the-knee prosthesis and determine the effects of prosthetic foot stiffness and effective length on CoM and CoP.Persons with a lower limb amputation walk with compensatory movements that affect the smooth trajectory of the center of mass (CoM) during weight transfer. The lack of control in the foot/ankle complex reduces fine motor movements, influencing the progression of the CoM and transfer of ground reaction forces represented by the center of pressure (CoP). Without control of the ankle joint, prosthetic users "fall" off of their trailing prosthetic limb during weight transfer, resulting in much more abrupt CoM and CoP transfers from trailing to leading limb. These abrupt movements during transfer not only increase stress on the sound limb, but also decrease the subject's energy efficiency during ambulation. The current study will further examine the CoP path and velocity in relation to the CoM path and velocity during double support of men with a transfemoral prosthesis, as well as explore how prosthetic foot ankle stiffness and effective length affects the CoP path and velocity.

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Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

V.A. Long Beach Healthcare System

Long Beach, California, 90822, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have a transfermoral amputation and use an above-the-knee prosthesis with an articulating knee joint on a daily basis.
  • Participants must be male.
  • Age greater than or equal to 18 years, but less than 65 years.
  • Participants must have no known pathology or comorbidites that would affect their ambulatory ability
  • Ability to tolerate walking for a minimum of 100 yards over the course of a two and a half hour time period.
  • Ability to walk one block without needing to rest.

Exclusion criteria

  • Use of ambulatory aids such as canes or crutches.
  • Any medical or psychosocial condition that, in the opinion of the investigator, could jeopardize the subject's participation, and compliance with the study criteria.
  • Bilateral amputations.

Treatment and study plan

Level overground ambulation

Other

Primary outcomes

  1. Center of Pressure Velocity

    Time frame: Double Support Phase of Gait Cycle (2.5 hour)

    The Center of Pressure velocity in the X and Y direction [cm/sec] will be collected using a motion capture system and forceplates during a single session. This data will be collected during a single 2.5 hour data collection session. The time frame is specifically the Double Support phase of the gait cycle.

Sponsors and collaborators

Lead sponsor

Southern California Institute for Research and Education

Other

Registry information

Official study title

Investigation of Medial Lateral Displacement of Center of Pressure and Center of Mass During Double Support in Men With Unilateral Transfemoral Amputations.

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Nov 24, 2014
Registry last updated
May 3, 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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