Influence of Socket Volume on Prosthesis Performance

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02124915

Acronym

CAD

Enrollment

Registered

2014-04-28

Start date

2013-02-28

Completion date

2014-12-31

Last updated

2017-08-24

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

Conditions

Lower Limb Amputation Below Knee (Injury)

Keywords

prosthetic socket, amputee

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Residual limb fluid volume	1 month

Secondary

Measure	Time frame
Activity	1 month

Other

Measure	Time frame
Comfort and prosthesis satisfaction	1 month
Gait	1 month

Countries

United States

Outcome results