Socket-leg Interface Movements in Transtibial Amputees

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorNorwegian University of Science and Technology

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

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

Norwegian University of Science and Technology

Lead sponsor

Trøndelag Ortopediske Verksted (English translation: Trøndelag Orthopedic Workshop)

Collaborator