Status:
COMPLETED
Protocole Access-Socket
Lead Sponsor:
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Collaborating Sponsors:
Institution Nationale des Invalides
Hôpital d'Instruction des armées Percy
Conditions:
Lower Limb Amputation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Lower limb amputation has a definitive impact on a person's locomotor abilities, considerably reducing his or her autonomy in everyday life. 50% of lower limb amputees in France are trans-femoral. The...
Eligibility Criteria
Inclusion
- Unilateral or bilateral trans-femoral amputees;
- Fitted with a rigid carbon insert;
- Any type of stump;
- Any etiology;
- Person able to understand simple commands, to read, write and give informed consent or having the possibility to be accompanied by a trusted person in case of inability to write or read independently;
- Person who has given informed consent;
- Person who has reached the age of 18 years;
- Person affiliated to the french social security system
Exclusion
- Fitted with a collar fixed on a socket
- Using SHA for inserting the insert;
- Pregnant or nursing woman;
- Minor;
- Person of full age under legal protection or unable to give consent;
- Person under guardianship or curatorship;
- Person under legal protection.
Key Trial Info
Start Date :
February 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT05224232
Start Date
February 14 2022
End Date
October 31 2023
Last Update
February 7 2024
Active Locations (4)
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1
Hôpital d'Instruction des Armées (HIA) Percy
Clamart, France, 92140
2
Institut Régional de Médecine Physique et de Réadaptation de Nancy
Nancy, France, 54000
3
Centre d'Etudes et de Recherche sur l'Appareillage des Handicapés
Paris, France, 75700
4
Institution Nationale des Invalides
Paris, France, 75700