Application of ultrasound to monitor bone movement within transtibial prosthetic sockets: A pliot study

Completed

• Conditions: onderbeen amputatie; below knee amputation; transtibial amputation

• Registration Number: NL-OMON54922
• Lead Sponsor: Militair Revalidatie Centrum Aardenburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

Uni-lateral transtibial amputees;
Wearing a prosthetic for at least 1 year;
Able to walk without assistive walking aid during measurements;
At least 18 years old;
Stump is considered suitable for sub-atmospheric pressure fitting
No restrictions are being made due to: gender or ethnic background.

Exclusion Criteria

Stump problems;
Cognitive or communicative disorders;
Visual impairments which would limit the participants balance

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Total displacement of the distal tibia relative to the socket for each step in<br /><br>5 stepping conditions and the maximal displacement in anterior/posterior/medial<br /><br>and lateral direction. Influence of alignment changes on tibial movement will<br /><br>be investigate by comparing the mean tibial movement between alignment<br /><br>conditions within the same step direction. In addition, test-retest and<br /><br>inter-observer reliability will be investigated with two-way mixed effect ICC<br /><br>model for absolute agreement.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-</p><br>