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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
| Bispebjerg Hospital | OTHER |
| Odense University Hospital | OTHER |
| Copenhagen University Hospital, Hvidovre |
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Patients with chronic edema of the lower limb referred to compression bandaging in a hospital setting will be invited to participate in the validation study of a novel sensor (CIMON), which have been developed for assessing the effect of compression bandaging. Participants will have the sensor applied to the lower limb before initiation of compression bandaging and will receive usual compression treatment according to severity of the edema and usual practice at the treatment site. Duration of participation is 14 days.
The CIMON sensor is developed with the purpose of monitoring the effectiveness of compression bandaging (CB) in patients with chronic edema by application to the widest circumference of the calf. CIMON measures the difference in capacitance by stretching the circumferential sensor. Data from the sensor is transferred by Bluetooth technology to a secured webserver, where healthcare professionals can monitor the effect of compression bandaging.
The study aims to assess the psychometric properties of the CIMON (reliability, validity and responsiveness) and assess the correlation between edema reduction and physical activity during compression bandaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with chronic edema of the lower limbs | Patients with chronic edema of the lower limbs referred to compression bandaging in a hospital setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CIMON | Other | The sensor assess changes in the circumference of the limb and will be applied to the lower limb before compression bandaging is applied. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Edema reduction | Assessed by Cimon sensor (in capacitans, pF) | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Edema reduction | Assessed by tape measurement (in cm), converted to volume by formula of truncated cone | 14 days |
| Edema reduction | Assessed by perometry (in ml) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic edema of the lower limbs referred to compression bandaging in a hospital setting.
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| Name | Affiliation | Role |
|---|---|---|
| Carsten Bogh Juhl, Professor | Herlev and Gentofte Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, Frederiksberg Bispebjerg Hospital | Bispebjerg | Capital Region | Denmark | |||
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| ID | Term |
|---|---|
| D014689 | Venous Insufficiency |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
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| Sens Motion | Other | The sensor assess physical activity and the amount of time spent at rest, standing, walking, running and count steps. |
|
| 14 days |
| Edema reduction | Assessed by Dual energy X-ray Absorptiometry (in kg) | 14 days |
| Symptoms related to chronic edema | Self-reported pain, tension and heaviness | 14 days |
| Physical Activity (PA) | Assessed by Sens Motion sensor (PA by sedentary time, low+moderate and high intensity in minutes) | 14 days |
| Adverse events | Any adverse events related to compression bandaging and the application of sensors | 14 days |
| Department of Physiotherapy and Occupational Therapy, Rigshospitalet |
| Copenhagen |
| Capital Region |
| 2100 |
| Denmark |
| Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital | Herlev | Capital Region | 2730 | Denmark |
| Department of Physiotherapy and Occupational Therapy, Amager Hvidovre Hospital | Hvidovre | Capital Region | Denmark |
| Department of Oncology, Unit of Lymphedema care, Odense University Hospital Svendborg | Odense | Region Syddanmark | Denmark |