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Prosthetic Socket Fit Testing System 18 Non-Invasive

Not yet recruiting
Clinical Trial NCT07491614 is an interventional study for Amputation and is currently not yet recruiting. Enrollment is planned to begin on 1 April 2026 and continue until the study accrues 18 participants. Led by University of Washington, this study is expected to complete by 28 February 2027. The latest data from ClinicalTrials.gov was last updated on 24 March 2026.
Brief Summary
Ensuring a well fitting prosthetic socket is a major challenge in the care of people with amputation. Poor fit causes pain, skin issues, reduced mobility, and lower satisfaction, affecting daily activity and quality of life. Current prosthetic socket fit assessment relies on prosthesis user feedback, prosthetist experience or intrusive equipment. The investigators have developed a non-invasive prototype socket fit te...Show More
Detailed Description
One of the biggest challenges in prosthetic care is making sure the prosthetic socket fits well with the residual limb. This "socket fit" is critical for both comfort and function. When the socket doesn't fit properly, it can cause pain, skin problems, and reduced performance. Poor socket fit can also lower a person's satisfaction with their prosthesis, limit their ability to perform daily activities, and negatively ...Show More
Official Title

Evaluation of a Prototype Socket Fit Testing System to Assess Coupling of the Prosthetic Socket in Individuals With Lower Limb Amputation

Conditions
Amputation
Other Study IDs
NCT ID Number
NCT07491614
Start Date (Actual)
2026-04-01
Last Update Posted
2026-03-24
Completion Date (Estimated)
2027-02-28
Enrollment (Estimated)
18
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
prosthesis
assessment
socket fit
Primary Purpose
Other
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
OtherIndividuals with transfemoral amputation
Prosthetic socket fit testing system
Prosthetic socket fit testing system
Prosthetic socket fit testing system to assess socket-limb coupling using movement error and duration.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Repeatability
Assess repeatability of performing the prosthetic socket fit test in terms of movement time and accuracy.
1 week
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Practice effects
Assess how many trials are required for steady state performing the prosthetic socket fit test in terms of movement time and accuracy.
Day 1
Known groups validity
Assess difference in measurement time and accuracy between loose and tight prosthetic socket fit
Day 1
Convergent validity
Assess correlation between movement time and accuracy with socket comfort score for difference between tight and loose fitting prosthetic sockets.
Day 1
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • be between 18 and 70 years old
  • have a unilateral transfemoral amputation
  • be at least 12 months post-amputation
  • have a residual limb that is free of open wounds or infections
  • wear a prosthesis for a minimum of four hours per day
  • be able to ambulate short distances with a prosthesis
  • be able to stand on the intact leg for brief periods
  • be able to hold onto parallel bars with the arms for balance
  • have pain-free range of motion at the hip on the amputated side
  • have no back problems that make standing or hip movement difficult
  • have corrected vision that is sufficient to see the cursors on the screen
  • be able to follow simple instructions in English

  • residual limb issues (e.g. sensitive or frail skin) that may be made worse by testing
  • a prosthetic socket that cannot be disconnected from the distal prosthetic components
  • unable to read and speak English
University of Washington logoUniversity of Washington398 active studies to explore
National Center for Advancing Translational Sciences (NCATS) logoNational Center for Advancing Translational Sciences (NCATS)
Study Responsible Party
Stefania Fatone, Principal Investigator, Professor, Department of Rehabilitation Medicine, University of Washington
Study Central Contact
Contact: Stefania Fatone, PhD, BPO(Hons), 206-685-7918, [email protected]
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