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Socket is key to provide comfort and function to lower limb amputees. A new socket, the sub-ischial socket, will be compared to "traditional" ischial containment sockets, based on comfort self-evaluation, and locomotor capacities.
Subjects wearing ischail containment sockets will be proposed to enter the research. They will be provided and fitted with a sub-ischial socket. Randomly, they will use one or the other socket for four weeks, then be tested : finctional test and questionnaires. After this testing session, they will use the other socket, and be re-tested accordingly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sub-ischial socket | Experimental | Start using the sub-ischial socket for four weeks and be tested with this socket. |
|
| Ischial containment socket | Active Comparator | Start using the ischial containment socket for four weeks and be tested with this socket. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Socket evaluation | Device | The subject will wear the socket for 4 weeks, and then reply questionnaires and achieve a 2-minute walking test |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comfort evaluation | Socket Comfort Score (SCS) | 1 minute |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort evaluation in various situations | Same question for four detailed situations | 1 minute |
| Locomotor capability | PLUS-M questionnaire and 2-minute walking test |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Les Capucins | Angers | 49100 | France | |||
| UGECAM La Tour de Gassies |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| 5 minutes |
| Bruges |
| 33523 |
| France |
| Clinique du Cabirol | Colomiers | 31771 | France |
| Hôpital Léon Bérard | Hyères | 83418 | France |
| UGECAM - IRR Nancy | Nancy | 54000 | France |
| Institution Nationale des Invalides | Paris | 75007 | France |
| Centre Mutualiste de Kerpape | Ploemeur | 56275 | France |
| UGECAM La Tourmaline | Saint-Herblain | 44818 | France |
| CHBA Vannes | Vannes | 56000 | France |