Pilot Efficacy Study of the Stendo Pulsating Suit in Patient With Leg Lymphoedema
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|ClinicalTrials.gov Identifier: NCT02234674|
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : May 22, 2015
This study aims at evaluating the efficacy of the Stendo pulsating suit in patients with a leg lymphedema hospitalized for intensive Complex Decongestive Physiotherapy (CDP).
This study is a pilot controlled randomized study with two arms.
|Condition or disease||Intervention/treatment||Phase|
|Primary Lower Limb Lymphedema Secondary Lower Limb Lymphedema||Other: Current intensive CDP Other: intensive CDP where Stendo pulsating suit replaces pressotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Efficacy Study of the Stendo Pulsating Suit in Patient With Leg Lymphoedema|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
Active Comparator: Standard intensive CDP
This arm is the controlled group ; patients in that group will undergo a current practice performed in the lymphology unit.
Other: Current intensive CDP
Standard Intensive CDP including
Experimental: Stendo group
This arm contitutes the group where the Stendo pulsating suit sessions are investigated in the frame of the CDP in replacement of the pressotherapy sessions.
Other: intensive CDP where Stendo pulsating suit replaces pressotherapy
The intervention consist to perform daily during 5 days an intensive CDP where pressotheray is replaced by Stndo pulsating suit sessions.
- volume of the most affected leg [ Time Frame: baseline ; after 5 days intensive CDP ]Change in % of the volume of the most affected leg according to disk model method
- Quality of Life [ Time Frame: baseline ; after 5 days intensive CDP ]36 health survey questionnaire (SF-36) and Visual Analogical Scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234674
|CHIC Des Andaines|
|La FERTE MACE, France, 61600|