About this trial
This exploratory interventional study investigates dynamic prosthetic fit in unilateral transtibial prosthesis users by objectively measuring socket-leg interface movements (SLMs) during functional activities. During one single study visit, participants complete standardized laboratory tasks using three different suspension systems (pin-lock, passive vacuum, and active vacuum) applied to a transparent replica of their current prosthetic socket. Motion capture, force measurements, and patient-reported outcomes are used to evaluate how suspension systems influence interface motion, rotation resistance, gait characteristics, and user comfort. The study aims to improve clinical understanding of prosthetic fit and support more informed prosthetic decision-making in routine care.
Eligibility criteria
Qualifiers
Age ≥16 years
Unilateral transtibial amputation
Activity level K2-K4
Actively using a prosthesis for ≥12 months
Disqualifiers
Use of a thigh corset attached to the prosthesis
Requirement of a walker for ambulation
Open wounds, skin ulcers, or blisters on the residual limb
No liner
Trial design
Treatments tested in this trial
- Pin-Lock Suspension System
- Passive Vacuum Suspension System
- Active Vacuum Suspension System
Treatment groups
Sponsors and collaborators
Norwegian University of Science and Technology
Lead sponsor
Trøndelag Ortopediske Verksted (English translation: Trøndelag Orthopedic Workshop)
Collaborator