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Completed

NCT Number: NCT01684501

Comparing Active and Passive Ankle-foot Prostheses

The purpose of this study is to perform a biomechanical study of a prototype prosthetic foot and evaluate if it provides a physiological generation of power at the ankle in transtibial amputees. The prosthetic foot is a prototype system that generates power via actuators (i.e. robotic system).

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Key information

Conditions

Trans-tibial Amputation

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Spaulding Rehabilitation Hospital Boston

Boston, Massachusetts, 02114, United States

About this study

Subjects will be studied during level-ground walking. A camera-based motion capture system will be used to study the biomechanics of motion and evaluate if the pattern of ankle power generation by the prosthetic foot is physiological. In addition, the metabolic cost of ambulation will be monitored during walking at constant speed over a period of several minutes. The data will allow us to assess if the prosthetic foot leads to a decreased metabolic cost of ambulation compared to passive prosthetic feet.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • weigh more than 200 lbs
  • are high level ambulators corresponding to levels E to F of the Special Interest Group of Amputee Medicine (SIGAM) mobility grade
  • have the ability to follow multi-step commands.

Exclusion criteria

  • score level D on the SIGAM mobility grade
  • have experienced 1 or more falls in the last month before the study
  • have a residual limb length which does not allow for seven inches clearance of bracket attachment for the PowerFoot
  • the residual limb must be stable in volume (no change in socket or socket padding in last 6 months) and without pain that limits function
  • the sound-side (contralateral) lower extremity must be free of impediments that affect gait, range of motion, or limb muscle activity
  • Any diagnosed cardiovascular, pulmonary, neurological, and/ or orthopedic conditions that would interfere with subject participation

Treatment and study plan

Primary outcomes

  1. Ankle power generation

    Time frame: During the session trial (approx 10 minutes)

    Ankle power derived using a camera-based motion capture system during walking

Secondary outcomes

  1. Metabolic cost of ambulation

    Time frame: During the session trial (approx 10 minutes)

    Oxygen consumption during level-ground walking

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 13, 2012
Registry last updated
Apr 12, 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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