NCT00061217

Brief Summary

People who have had a leg amputated often choose to use a prosthetic (artificial) leg. This study will evaluate a new method of making prosthetic legs for people who have had an amputation below the knee.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
59

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2001

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 23, 2003

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
Last Updated

June 24, 2005

Status Verified

October 1, 2004

First QC Date

May 22, 2003

Last Update Submit

June 23, 2005

Conditions

Amputation

Keywords

Transtibial amputeesRectified socketsUnrectified socketsGaitEnergy expenditureProsthetic evaluation questionnaire

Outcome Measures

Primary Outcomes (3)

  • socket selection

  • PEQ

  • gait speed

Secondary Outcomes (3)

  • gait kinematics

  • gait kinetics

  • energy consumption

Interventions

Unrectified prosthetic socketDEVICE
Rectified prosthetic socketDEVICE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral transtibial amputation
  • Mature residual limbs (i.e., no major change in stump volume due to atrophy or other destabilizing factors)
  • Continuously worn a prosthesis for at least 1 year prior to study entry
  • Scheduled for a new prosthesis
  • Independent ambulation
  • No acute health problems

You may not qualify if:

  • Constant recurring prosthetic problems (i.e., adherent scar tissue, neuromas, bony protuberances at distal end)
  • Requires gel inserts, additional ply socks, or other atypical fitting components or methods
  • Health status that prohibits patient from performing graded exercise test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jack R. Engsberg

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Engsberg JR, Sprouse SW, Uhrich ML, Ziegler BR, Luitjohan FD. Comparison of Rectified and Unrectified Sockets for Transtibial Amputees. J Prosthet Orthot. 2008;18(1):1-7. doi: 10.1097/00008526-200601000-00002.

    PMID: 18776945BACKGROUND

Study Officials

  • Jack R. Engsberg, Ph.D.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

May 22, 2003

First Posted

May 23, 2003

Study Start

April 1, 2001

Study Completion

March 1, 2005

Last Updated

June 24, 2005

Record last verified: 2004-10

Locations

US(1)