Clinical usability of non-contact scanners in measuring stumpvolume of transtibial amputee patients

Completed

Conditions: transtibial amputation
amputatie

Registration Number: NL-OMON45575

Lead Sponsor: Isala Klinieken

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 36

Inclusion Criteria

Uni- or bilateral transtibial amputation
Operation of the stump more than 1 year ago
Older than 18 years
Informed consent
Availability at research data

Exclusion Criteria

Less than 1 year ago an operation of the stump
Large changes in stump volume during the day with co-morbidity like heart failure, kidney failure, deep vein thrombosis, lymphedema, fracture of the leg, rheumatoid artritis, CRPS, dermatologic diseases associated with edema.
Wound at the stump of more than 1 cm amplitude and/or signs of infection, in which clinically may be assumed that this will influence the stumpvolume
Weakness of upperleg which causes inability to lift the leg up in the air
Not able to make a transfer from (wheel)chair to research table
Not enough understanding of the Dutch language to give answer to simple questions, follow simple instructions or understand the informed consent letter

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Stumpvolume will be calculated per patient per CAD/CAM system, where the<br /><br>mid-patellar tendon point, tibial crest and supracondylar level will be used as<br /><br>measurement points. So every session there will be 8 measurements per patient,<br /><br>which will be repeated the second session. Per system per patient there will be<br /><br>a mean measured volume calculated per researcher and per session. With that the<br /><br>repeatability coefficient for intra-observer and test-retest reliability will<br /><br>be calculated. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The PSSUQ will be collected per CAD/CAM system in every researcher. Patients<br /><br>will be asked about how they experience the measurement on a scale from 1 to<br /><br>10. The mean score per system will be calculated and compared. Also the mean<br /><br>time necessary to perform the measurement will be calculated per CAD/CAM<br /><br>system. The shorter the mean time necessary per measurement, the better.</p><br>