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| Name | Class |
|---|---|
| KU Leuven | OTHER |
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This clinical study evaluates the reliability, concurrent validity, and clinical feasibility of a new method to determine leg volume, namely the Structure Sensor Scanner.
The volume of both legs will be determined using three different measurement methods:
To investigate the reliability, the intra-class correlation coefficient (ICC) is calculated as well as the SEM, SRD and a two-tailed paired samples t-test or a wilcoxon signed rank test (in case of not-normally distributed data). To investigate the concurrent validity of the Structure Sensor Scanner, the results from the scanner method will be compared with those of the two other methods. Regarding the clinical feasibility the duration of each measurement is recorded and a purpose-designed feasibility questionnaire which is completed by the assessors is used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 33 patients with LLL | patients with unilateral or bilateral, primary or secundary LLL who visit the center for lymphedema at UZ Leuven |
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| Measure | Description | Time Frame |
|---|---|---|
| Within-session reliability of leg volume measurements using the Structure Sensor Scanner, circumference measurements, and optoelectronic volumetry. | Leg volumes were measured using three methods: the Structure Sensor Scanner device, manual circumference measurements, and optoelectronic volumetry. Intra-rater and inter-rater reliability were assessed through two measurements conducted by assessor A and one by assessor B. Reliability was evaluated using Intraclass Correlation Coefficients (ICC), Standard Error of Measurement (SEM), paired samples t-tests, and Smallest Real Difference (SRD). | One visit linked to a routine follow-up appointment at the hospital (within-session) |
| Within-session concurrent validity of leg volume measurements using the Structure Sensor Scanner, circumference measurements, and optoelectronic volumetry. | Leg volumes were measured using three methods: the Structure Sensor Scanner device, manual circumference measurements, and optoelectronic volumetry. Concurrent validity was assessed through Pearson correlation coefficients between the measurement methods. | One visit linked to a routine follow-up appointment at the hospital (within-session) |
| Clinical feasibility of leg volume measurements using the Structure Sensor Scanner, circumference measurements, and optoelectronic volumetry. | Leg volumes were measured using three methods: the Structure Sensor Scanner device, manual circumference measurements, and optoelectronic volumetry. Clinical feasibility was determined by recording the duration of each measurement and using a purpose-designed feasibility questionnaire completed by the assessors. | One visit linked to a routine follow-up appointment at the hospital |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with unilateral or bilateral, primary or secondary LLL will be recruited at the center for lymphedema in UZ Leuven.
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| Name | Affiliation | Role |
|---|---|---|
| Nele Devoogdt, PhD | KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Leuven, center for lymphedema | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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