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OpenTrials
Completed

NCT Number: NCT02124915

Influence of Socket Volume on Prosthesis Performance

The purpose of this study is to investigate how residual limb fluid volume, gait, prosthesis use, perceived comfort, and satisfaction with the prosthesis are affected by size of the prosthetic socket. Subjects are tested after wearing a nominal socket for 1 month and again after wearing a slightly oversized socket for 1 month.

Completed

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Key information

Conditions

Lower Limb Amputation Below Knee (Injury) Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Washington

Seattle, Washington, 98075, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • transtibial amputee
  • at least 18 months post amputation
  • over 18 years of age
  • capable of treadmill walking and 90 seconds of continuous standing

Exclusion criteria

  • skin breakdown on the residual limb

Treatment and study plan

Primary outcomes

  1. Residual limb fluid volume

    Time frame: 1 month

Secondary outcomes

  1. Activity

    Time frame: 1 month

Other outcomes

  1. Comfort and prosthesis satisfaction

    Time frame: 1 month

  2. Gait

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Acronym: CAD

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 28, 2014
Registry last updated
Aug 24, 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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