NCT04791163
Completed
N/A
AK Socket Evaluation : Sub-ischial vs Ischial Containment. Multi-center Randomised Crossover Study
Proteor Group9 sites in 1 country25 target enrollmentApril 15, 2021
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Lower Limb Amputation Above Knee (Injury)
- Sponsor
- Proteor Group
- Enrollment
- 25
- Locations
- 9
- Primary Endpoint
- Comfort evaluation
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •can give informed consent
- •aged 18 or more
- •above-knee amputee, wearing a definitive ischial containment socket
- •stump longer than 16cm
- •wearing a liner, whatever the suspension system
- •able to walk (d4600, d4601, d4602, d4608 accordinf to IFC)
- •unilaterla or bilateral amputee
- •able to done the socket standing
- •whatever the etiology
Exclusion Criteria
- •protected person
- •pregnant woman or nursing mother
- •subject having comorbidities heavily impacting feeling or socket donning
- •allergic to silicon
- •suffering from big volume variations in a same day
- •infecté stump (may lead to lymphatic problems)
Outcomes
Primary Outcomes
Comfort evaluation
Time Frame: 1 minute
Socket Comfort Score (SCS)
Secondary Outcomes
- Comfort evaluation in various situations(1 minute)
- Locomotor capability(5 minutes)
Study Sites (9)
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