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. 2023 Jul 14;15:85. doi: 10.1186/s13102-023-00694-4

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..)