Socket-leg Interface Movements in Transtibial Amputees

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.

NCT Number	NCT07521891
Lead Sponsor	Norwegian University of Science and Technology Collaborators: Trøndelag Ortopediske Verksted (English translation: Trøndelag Orthopedic Workshop)
Conditions	Transtibial Amputation - Unilateral
Enrollment	20 participants
Start Date	2026-04-20
Primary Completion	2027-02-27 (estimated)
Study Completion	2029-12-27 (estimated)
Updated on ClinicalTrials.gov	2026-04-13