NCT04791163

Above-knee Socket Evaluation : Sub-ischial vs Ischial Containment

AK Socket Evaluation : Sub-ischial vs Ischial Containment. Multi-center Randomised Crossover Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Proteor Group · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lower Limb Amputation Above Knee (Injury)

Interventions

Type	Name	Description
DEVICE	Socket evaluation	The subject will wear the socket for 4 weeks, and then reply questionnaires and achieve a 2-minute walking test

Timeline

• Start date: 2021-04-15
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2021-03-10
• Last updated: 2022-08-09

Locations

9 sites across 1 country: France