Amputee Residual Limb Volume Fluctuation

Measuring and Controlling In-Socket Residual Limb Volume Fluctuation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01161238

Enrollment

Registered

2010-07-13

Start date

2010-05-31

Completion date

2011-09-30

Last updated

2014-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amputation

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.

Interventions

OTHERMonitored for limb volume

Subjects are monitored for limb volume change using bioimpedance analysis

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
Residual limb fluid volume	1 day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026