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Socket-leg Interface Movements in Transtibial Amputees

NCT07521891 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Transtibial Amputation - Unilateral

Interventions

DEVICE

Pin-Lock Suspension System

Participants perform all tasks using a pin-lock suspension system applied to their test socket.

DEVICE

Passive Vacuum Suspension System

Participants perform all tasks using a passive vacuum suspension system applied to their test socket.

DEVICE

Active Vacuum Suspension System

Participants perform all tasks using an active vacuum suspension system applied to their test socket.

Sponsors & Collaborators

  • Trøndelag Ortopediske Verksted (English translation: Trøndelag Orthopedic Workshop)

    collaborator UNKNOWN

  • Norwegian University of Science and Technology

    lead OTHER

Principal Investigators

  • Karin Roeleveld · National Taiwan Normal University

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-20
Primary Completion
2027-02-27
Completion
2029-12-27

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07521891 on ClinicalTrials.gov