Socket-leg Interface Movements in Transtibial Amputees
Norway20 participantsStarted 2026-04-20
Plain-language summary
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.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥16 years
* Unilateral transtibial amputation
* Activity level K2-K4
* Actively using a prosthesis for ≥12 months
* Ability to understand and communicate in Norwegian (oral and written)
* Digital file of current socket model available (required for test socket fabrication)
Exclusion Criteria:
* 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
* Missing digital socket model file
* Medical advice to avoid physical activity similar to study tasks
* Other medical conditions that may worsen with activity and have not been cleared by a healthcare professional
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Socket-Liner Motion [mm]
Timeframe: Within 1 hour after fitting the suspension system
2
Proximal-distal Socket-Leg Motion [mm]
Timeframe: Within 1 hour after fitting the suspension system
Trial details
NCT IDNCT07521891
SponsorNorwegian University of Science and Technology