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NCT Number: NCT07521891

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Transtibial prosthetic fit strongly influences user comfort, gait quality, and long term functional outcomes. Current clinical assessment methods rely primarily on subjective clinical observation and user feedback. Dynamic socket-leg interface motion (SLM) offers an objective biomechanical indicator of prosthetic fit, but existing studies are limited in sample size, measurement directions, and evaluation across different suspension systems.

This study evaluates SLMs using 3D motion capture, force sensors, and a dynamometer while participants perform three standardized task categories:

isometric rotation tasks to determine rotation resistance and torque thresholds for interface rotation; turning/rotational/pivoting walking tasks to assess functional performance and transverse plane dynamics; and treadmill walking at multiple speeds to quantify proximal-distal pistoning and gait kinematics.

Each participant is tested using three suspension system conditions (pin-lock, passive vacuum, active vacuum), starting with their preferred suspension system followed by a counterbalanced order to minimize bias. A transparent "test socket" replicating the participant's own socket allows interface visualization and marker tracking without altering the intended use of the prosthesis. The investigational device consists only of CE marked components used within their intended purpose.

Participants attend one study visit with a duration of approximately 4 to 5 hours, including prosthesis adjustment and placement, marker setup, data collection across all three task categories and with all three suspension system conditions.

The primary aim is to quantify the effects of suspension system and load conditions on SLMs and gait performance. Secondary aims assess relationships between objective SLM measures and patient reported comfort, functional ability with the prosthesis, and prosthesis satisfaction. Findings will support improved understanding of dynamic fit behavior, help characterize suspension system performance, and inform future development of objective prosthetic fitting assessment methods.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pin-Lock Suspension System

Device

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

Passive Vacuum Suspension System

Device

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

Active Vacuum Suspension System

Device

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

Primary outcomes

  1. Socket-Liner Motion [mm]

    Time frame: Within 1 hour after fitting the suspension system

    Socket-liner motion is quantified using a 3D optical motion-capture system to measure the relative movement between the prosthetic socket and liner during functional activities. Motion is recorded in millimeters (mm).

    Typical motion values are expected to fall within the range of 0-20 mm.

  2. Proximal-distal Socket-Leg Motion [mm]

    Time frame: Within 1 hour after fitting the suspension system

    Proximal-distal Socket-Leg Motion is quantified using a 3D motion-capture system to measure the relative movement between the prosthetic socket and the remaining leg during functional activities. Motion is recorded in millimeters (mm).

    Typical motion values are expected to fall within the range of 0-30 mm.

Secondary outcomes

  1. Torque Required to Initiate Socket-Liner Rotation [Nm]

    Time frame: Within 1 hour after fitting the suspension system

    This measure quantifies the torque at which transverse rotation begins between the prosthetic socket and liner. Torque is measured in Newton-meters (Nm) using a dynamometer.

  2. Step length [cm]

    Time frame: Within 1 hour after fitting the suspension system

    Step length is quantified using a 3D motion-capture system during functional activities. Step length is recorded in centimeters (cm).

  3. Step length asymmetry index

    Time frame: Within 1 hour after fitting the suspension system

    Step length asymmetry will be assessed using 3D motion analysis instrumentation. Asymmetry is computed on step length (cm) of the prosthetic and intact legs, by dividing the difference between legs by the average of both legs. 0 marks perfect symmetry and greater values higher asymmetry. There is no maximum limit, but most values are expected to be below 1.

  4. Gait velocity [m/s]

    Time frame: Within 1 hour after fitting the suspension system

    Gait velocity is quantified using a 3D motion-capture system during functional activities. Gait velocity is recorded in meters per second (m/s).

  5. Patient-Reported Socket Comfort Score (SCS)

    Time frame: Within 1 hour after fitting the suspension system

    The Socket Comfort Score is a patient-reported numerical rating scale used to assess prosthetic socket comfort. Participants rate their comfort on a 0-10 scale, where 0 represents the most uncomfortable socket imaginable and 10 represents the most comfortable socket imaginable.

    Comfort is evaluated for each of the three suspension conditions. For every condition, the participant provides the score immediately after completing the turning task and treadmill-walking task, both performed within 60 minutes of fitting the corresponding suspension system.

  6. Perceived Functional Ability

    Time frame: Within 1 hour after fitting the suspension system

    Perceived functional ability is assessed using a patient-reported numerical rating scale that captures the participant's subjective evaluation of how well they are able to perform functional activities with the prosthesis. Participants rate their perceived functional ability on a 0-10 scale, where 0 indicates the lowest perceived functional ability and 10 indicates the highest perceived functional ability.

    For each of the three suspension conditions, participants provide this rating immediately after completing the turning task and treadmill-walking task, both performed within 60 minutes of fitting the respective suspension system.

  7. Prosthesis Satisfaction Score

    Time frame: Within 1 hour after fitting the suspension system

    The Prosthesis Satisfaction Score is a patient-reported numerical rating scale used to assess overall satisfaction with the prosthetic limb. Participants rate their satisfaction on a 0-10 scale, where 0 represents the lowest possible satisfaction and 10 represents the highest possible satisfaction.

    For each of the three suspension conditions, participants provide this rating immediately after completing the turning task and treadmill-walking task, both performed within 60 minutes of fitting the corresponding suspension system.

Other outcomes

  1. Socket-Leg rotation [degrees]

    Time frame: Within 1 hour after fitting the suspension system

    Socket-Leg rotation is quantified using a 3D motion-capture system to measure the relative movement between the prosthetic socket and the remaining leg during functional activities. Motion is recorded in angles (degrees).

    Typical values are expected to fall within the range of 0-15 degrees.

  2. Step length [% of bodyheight]

    Time frame: Within 1 hour after fitting the suspension system

    Step length is quantified using a 3D motion-capture system during functional ctivities activities. Step length is recorded in centimeters (cm) and presented as percentage of bodyheight.

  3. Knee angle [degrees]

    Time frame: Within 1 hour after fitting the suspension system

    The knee angle is quantified using a 3D motion-capture system during the functional activities and presented in degrees as a function of the gait cycle.

  4. Hip angle [degrees]

    Time frame: Within 1 hour after fitting the suspension system

    The hip angle is quantified using a 3D motion-capture system during the functional activities and presented in degrees as a function of the gait cycle.

  5. Foot progression angle [degrees]

    Time frame: Within 1 hour after fitting the suspension system

    The foot progression angle is quantified using a 3D motion-capture system during the functional activities and presented in degrees.

Study contacts

Contact information is provided by the study sponsor or research team.

Karin Roeleveld, PhD

CONTACT

[email protected]

+47 48177279

Maria J Lequerica, MSc

CONTACT

[email protected]

+47 48684299

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

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

Registry information

Official study title

Socket-leg Interface Movements as a Measure of Dynamic Prosthetic Fit for Transtibial Amputees: An Exploratory Study

Acronym: SLMinTTA

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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