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| Name | Class |
|---|---|
| University of South Wales | OTHER |
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The treatment of lymphoedema and its associated complications represent a considerable drain on increasingly limited NHS resources. Intermittent pneumatic compression (IPC) represents an innovative treatment for this condition, however the efficacy of IPC as a treatment for lower limb lymphoedema needs to be investigated via robust clinical research.
The primary aim of this research is to evaluate the effectiveness of intermittent pneumatic compression (IPC) as a treatment for lower limb lymphoedema as a whole, and to compare the effectiveness of a new generation device, in this case the LymphAssist (Huntleigh Healthcare), against older sequential models. The study methodology consists of a pilot randomised control trial of two groups - Intervention group A will continue to receive their standard lymphoedema care but will also be provided with a LymphAssist IPC device to use, mimicking manual lymph drainage therapy. Participants in intervention group B will receive their standard care plus an IPC device that uses sequential therapy. Each participant will act as a control for a 5 week period continuing with their standard treatment only. Outcome measures include impact on limb volume, skin stiffness and elasticity score and impact on quality of life scores.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group A | Experimental | LymphAssist IPC device - participants act as their own control for 5 weeks, receiving standard care only. After 5 weeks the group use the device twice a day, every day for a 5 week period. |
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| Intervention Group B | Experimental | Sequential IPC device - participants act as their own control for 5 weeks, receiving standard care only. After 5 weeks the group use the device twice a day, every day for a 5 week period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent Pneumatic Compression | Device | Participants administer an intermittent pneumatic compression device in addition to their standard lymphoedema care for a 5 week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Leg Volume | Circumferential measurements at every 4cm from the top of the ankle to the thigh will be used to calculate limb volume in mls | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Myoton Scores | The effect IPC has on skin stiffness (N/m), tone (Hz) and elasticity (D) | 5 weeks |
| Quality of Life Scores | The effect IPC has on quality of life scores - raw score created from a series of Likert Scales |
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Inclusion Criteria:
Exclusion Criteria:
• Unable to provide written consent
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| Name | Affiliation | Role |
|---|---|---|
| Mark Williams, PhD | University of South Wales | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dewi Sant Hospital | Pontypridd | CF37 1LB | United Kingdom |
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| ID | Term |
|---|---|
| D048228 | Intermittent Pneumatic Compression Devices |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| 5 weeks |