Table 2.
Inclusion and exclusion criteria
Inclusion criteria | Exclusion criteria |
---|---|
- Male or female aged >18 years old - Unilateral transtibial amputation > 6 months - Equipped with a Seal-in linera without VASS since at least 3 months - Equipped with a class II or III prosthetic footb compatible with the Unity system - ICF classification d4602 and/or d4608c [17] - Presenting some discomfort in the socket evaluated by a SCS ≤ 7/10 - Availability of daily smartphone use and functional 4G connection |
- Cognitive impairment impeding comprehension of the trial instructions - Patients who have already been equipped with the Unity VASS system in the past - Pregnancy - Adult under curatorship or guardianship - Patient with no health insurance - Severe comorbidities |
VASS Vacuum-Assisted Suspension System, ICF International Classification Of Functioning, Disability and Health, SCS Socket Comfort Score
aSeal-in is an Össur liner, compatible with the Unity system
bClass II or III stand for ICF d4602 and d4608, respectively, in the French National Health system
cd4602 = moving outside the house and other building; d4608 = other specified activities related to moving in and out of other locations (i.e. physical activities, professional activities, etc..)