Lymphedema
Conditions
Keywords
3D sensor, Lower Extremity, Upper Extremity, Body Regions, Measurement, Monitoring, Water displacement, Volume
Brief summary
Up to now, the diagnosis of lymphedema remains hard and delayed. It suffers from many limitations such as lack of coordination and formation of the health-care network. The diversity of used tools is another obstacle because all provided solutions on the market are either costless with poor accuracy, or highly expensive but with excellent accuracy. Therefore, we decided to evaluate an affordable and open-source 3D iPad sensor sharing the same technology used in Kinect sensors.
Interventions
DEVICEWater displacement volumetry
The examination will take place in several stages and by two operators. Initially, the patient will strip the limb concerned (leg or arm). Once the member is in the water column of the volumeter, a delimitation of the submerged area of the member will be carried out using a marking (black dermographic marker). Indeed, the level of acquisition in 3D is determined relative to the height of the water line marked on the skin with a black felt, this felt is usually used for venous mapping and is well tolerated The first operator will carry out two measurements one after the other with a change of water previously stabilized at room temperature.
DEVICEThree dimension volumetry
The 3D volumetric acquisition is done with the sensor (CE marking) attached to the touch pad and does not require invasive or cutaneous contact with the patient (minimum acquisition distance of 40 cm). The operator triggers the acquisition via a button in an application installed on the tablet and physically turns around the patient to carry out the acquisition of the affected member. At the end of the acquisition, the operator presses a stop button and chooses whether or not to calculate the volume using another button depending on the quality of the acquisition.
Sponsors
University Hospital, Brest
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Unilateral lymphedema
Exclusion criteria
* Minor patient, * Bilateral lymphedema, * Trophic disorders: Acute or recent skin infection (\<1 month after the end of antibiotic therapy), unhealed wounds. * Predictable difficulties in carrying out the measurements due to the patient's physical limitations (maintenance of orthostatic or sitting position \<5 minutes) * Single or bilateral edema with a different etiology than lymphedema.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of a 3D sensor for lymphedema volumetry | One hour | Intra-class correlation coefficient (ICC) Mean bias and limits of agreement (LOA) derived from the Blant-Altman diagram Mean bias and limits of agreement (LOA) derived from the Blant-Altman diagram |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reproducibility of measurements made with a 3D sensor for lymphedema volumetry | One hour | Intra-class correlation coefficient (ICC) |
Countries
France
Outcome results
None listed