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

NCT02299674 | Completed

• 1 other identifier: 1316
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unilateral Transfemoral Amputation

Outcome Measures

Primary Outcomes (1)

• Center of Pressure Velocity

  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.

  Double Support Phase of Gait Cycle (2.5 hour)

Study Arms (1)

Persons with unilateral transfemoral amputation

Other: Level overground ambulation

Interventions

Level overground ambulation OTHER

Persons with unilateral transfemoral amputation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Persons with unilateral transfemoral amputation who are ambulatory with a prosthesis and no assistive device.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southern California Institute for Research and Education: lead

Study Sites (1)

V.A. Long Beach Healthcare System

Long Beach, California, 90822, United States

Location

Related Publications (9)

• Au, S. K., Weber, J., & Herr, H. (2009). Powered Ankle-Foot Prosthesis Improves Walking Metabolic Economy. IEEE Transactions on Robotics, 25(1), 51-66.

  BACKGROUND

• Donelan JM, Kram R, Kuo AD. Simultaneous positive and negative external mechanical work in human walking. J Biomech. 2002 Jan;35(1):117-24. doi: 10.1016/s0021-9290(01)00169-5.

  PMID: 11747890 BACKGROUND

• Herr HM, Grabowski AM. Bionic ankle-foot prosthesis normalizes walking gait for persons with leg amputation. Proc Biol Sci. 2012 Feb 7;279(1728):457-64. doi: 10.1098/rspb.2011.1194. Epub 2011 Jul 13.

  PMID: 21752817 BACKGROUND

• Hof AL, van Bockel RM, Schoppen T, Postema K. Control of lateral balance in walking. Experimental findings in normal subjects and above-knee amputees. Gait Posture. 2007 Feb;25(2):250-8. doi: 10.1016/j.gaitpost.2006.04.013. Epub 2006 Jun 5.

  PMID: 16740390 BACKGROUND

• Kadaba MP, Ramakrishnan HK, Wootten ME. Measurement of lower extremity kinematics during level walking. J Orthop Res. 1990 May;8(3):383-92. doi: 10.1002/jor.1100080310.

  PMID: 2324857 BACKGROUND

• Nolan KJ, Yarossi M. Weight transfer analysis in adults with hemiplegia using ankle foot orthosis. Prosthet Orthot Int. 2011 Mar;35(1):45-53. doi: 10.1177/0309364610393061.

  PMID: 21515889 BACKGROUND

• Orendurff MS, Segal AD, Klute GK, Berge JS, Rohr ES, Kadel NJ. The effect of walking speed on center of mass displacement. J Rehabil Res Dev. 2004 Nov-Dec;41(6A):829-34. doi: 10.1682/jrrd.2003.10.0150.

  PMID: 15685471 BACKGROUND

• Schmid M, Beltrami G, Zambarbieri D, Verni G. Centre of pressure displacements in trans-femoral amputees during gait. Gait Posture. 2005 Apr;21(3):255-62. doi: 10.1016/j.gaitpost.2004.01.016.

  PMID: 15760740 BACKGROUND

• Turnbull GI, Charteris J, Wall JC. Deficiencies in standing weight shifts by ambulant hemiplegic subjects. Arch Phys Med Rehabil. 1996 Apr;77(4):356-62. doi: 10.1016/s0003-9993(96)90084-2.

  PMID: 8607759 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Health System Specialist

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: November 24, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: May 1, 2017
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

US (1)