NCT01161238

Brief Summary

The goal of this project is a useful clinical instrument for diagnosis and treatment of residual limb volume fluctuation in individuals who use prosthetic limbs. One hypothesis to be tested is that the instrument effectively measures short and long term volume fluctuations in individuals with trans-tibial amputation. Another hypothesis to be tested is that when subjects add a sock or insert to the prosthesis residual limb volume decreases, and when they remove the sock or insert residual limb volume increases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 13, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

April 25, 2014

Status Verified

April 1, 2014

Enrollment Period

1.3 years

First QC Date

July 9, 2010

Last Update Submit

April 24, 2014

Conditions

Amputation

Outcome Measures

Primary Outcomes (1)

  • Residual limb fluid volume

    1 day

Study Arms (1)

Lower-limb amputee

Subjects with at least one lower limb amputated at the trans-tibial level

Other: Monitored for limb volume

Interventions

Monitored for limb volumeOTHER

Subjects are monitored for limb volume change using bioimpedance analysis

Lower-limb amputee

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

people with lower limb amputation that are ambulatory

You may qualify if:

  • trans-tibial amputees who have a regular prosthetist and who wear the prosthesis at least five hours per day.

You may not qualify if:

  • Inability to ambulate continuously with a prosthesis (with or without the use of an assistive device such as a cane or walker) for 10 minutes indoors on a level walkway. 2. Inability to shift from horizontal to vertical posture in 30 seconds.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington, Bioengineering Department

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • Sanders JE, Harrison DS, Allyn KJ, Myers TR. Clinical utility of in-socket residual limb volume change measurement: case study results. Prosthet Orthot Int. 2009 Dec;33(4):378-90. doi: 10.3109/03093640903214067.

    PMID: 19961297BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 9, 2010

First Posted

July 13, 2010

Study Start

May 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

April 25, 2014

Record last verified: 2014-04

Locations

US(1)