AmputationNCT07491614
Prosthetic Socket Fit Testing System
A study testing Prosthetic socket fit testing system in people with Amputation, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Amputation
- What is being tested?
- Prosthetic socket fit testing system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98195
Stefania Fatone, PhD, 206-685-7918, sfaton@uw.edu
About this study
Official title: Evaluation of a Prototype Socket Fit Testing System to Assess Coupling of the Prosthetic Socket in Individuals With Lower Limb Amputation
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 testing system that attaches externally to the end of any prosthetic socket and uses two air cylinders to apply resistance and track motion. During testing, socket motion is mapped to a cursor on a screen. Participants perform a test where they move their leg and socket to randomly presented targets. Movement duration and accuracy provide measures of how well the socket and leg move together. This pilot study will assess feasibility and validity of the socket fit testing system performance for above-the-knee prosthesis users.
Read the 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 impact quality of life.
Current methods of assessing socket fit are qualitative-based on patient feedback or comfort surveys-or they use expensive and/or invasive equipment. These methods don't provide precise measurements of how well the socket and residual limb are working together, and some require altering the socket to insert instrumentation inside.
To address these limitations, the investigators are testing a non-invasive prototype device for measuring socket fit. This device attaches externally to the end of any prosthetic socket and uses two long air cylinders connected to sensors (potentiometers and load cells) and a TV monitor. With it, prosthesis users can perform different leg movements against resistance while wearing their socket.
The standardized test protocol requires participants to perform hip movements in all directions (flexion, extension, abduction, and adduction). The movement range is scaled to each person's height and hip motion, so the test has a consistent level of difficulty across individuals. The main hypothesis is that a better socket fit will allow more accurate movements, measured by how long the movements take and how much error is present. The overarching hypothesis is that better socket fit will result in more accurate movements, as measured by movement duration and error.
In this study, the investigators will evaluate the prototype device in adults with unilateral above-the-knee (transfemoral amputation, TFA). The investigators plan to recruit 18 participants with TFA:
- Eight participants with TFA will complete 2 testing visits to examine whether practice influences results and to confirm that the protocol is feasible.
- Ten participants with TFA will be purposively sampled to ensure that their current socket includes features that can make the fit easy to adjust. Participants will complete 2 testing visits so the investigators can determine whether the system can measure differences in socket-limb coupling, using metrics such as movement duration and error.
The investigators will also compare these movement metrics with participants' self-reported Socket Comfort Scores. Showing that the test protocol is feasible to implement, the device operates as intended, and differences in coupling can be detected will give the investigators pilot data to support larger clinical trials.
Specific Aims
- Test the feasibility, repeatability and practice effects of the prototype socket fit testing protocol in people with transfemoral amputation.
- Show that the system can detect differences in socket fit in people with transfemoral amputation, using movement metrics such as duration and error.
- Validate the movement metrics by comparing them to patient-reported Socket Comfort Scores.
- Conditions
- Amputation
- Being tested
- Prosthetic socket fit testing system
- Keywords
- prosthesis, assessment, socket fit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetic socket fit testing systemDevice
Prosthetic socket fit testing system to assess socket-limb coupling using movement error and duration.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with transfemoral amputation | Other | Prosthetic socket fit testing system Receives: Device: Prosthetic socket fit testing system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeatability
Assess repeatability of performing the prosthetic socket fit test in terms of movement time and accuracy.
Measured: 1 week
Secondary outcomes (3)
Practice effects
Assess how many trials are required for steady state performing the prosthetic socket fit test in terms of movement time and accuracy.
Measured: Day 1
Known groups validity
Assess difference in measurement time and accuracy between loose and tight prosthetic socket fit
Measured: Day 1
Convergent validity
Assess correlation between movement time and accuracy with socket comfort score for difference between tight and loose fitting prosthetic sockets.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start12 Oct 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Stefania Fatone, University of Washington
- Investigators
- Stefania Fatone, PhD, BPO(Hons), Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491614
- Sponsor's protocol ID
- STUDY00023726
- Other IDs
- UL1TR002319
- Status last verified
- Oct 2026
- First submitted
- 15 Mar 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Prototype Socket Fit Testing System to Assess Coupling of the Prosthetic Socket in Individuals With Lower Limb Amputation
- ClinicalTrials.gov ID
- NCT07491614
- Acronym / sponsor ID
- STUDY00023726
- Conditions
- Amputation
- Keywords
- prosthesis, assessment, socket fit
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 12 Oct 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 testing system that attaches externally to the end of any prosthetic socket and uses two air cylinders to apply resistance and track motion. During testing, socket motion is mapped to a cursor on a screen. Participants perform a test where they move their leg and socket to randomly presented targets. Movement duration and accuracy provide measures of how well the socket and leg move together. This pilot study will assess feasibility and validity of the socket fit testing system performance for above-the-knee prosthesis users.
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 impact quality of life.
Current methods of assessing socket fit are qualitative-based on patient feedback or comfort surveys-or they use expensive and/or invasive equipment. These methods don't provide precise measurements of how well the socket and residual limb are working together, and some require altering the socket to insert instrumentation inside.
To address these limitations, the investigators are testing a non-invasive prototype device for measuring socket fit. This device attaches externally to the end of any prosthetic socket and uses two long air cylinders connected to sensors (potentiometers and load cells) and a TV monitor. With it, prosthesis users can perform different leg movements against resistance while wearing their socket.
The standardized test protocol requires participants to perform hip movements in all directions (flexion, extension, abduction, and adduction). The movement range is scaled to each person's height and hip motion, so the test has a consistent level of difficulty across individuals. The main hypothesis is that a better socket fit will allow more accurate movements, measured by how long the movements take and how much error is present. The overarching hypothesis is that better socket fit will result in more accurate movements, as measured by movement duration and error.
In this study, the investigators will evaluate the prototype device in adults with unilateral above-the-knee (transfemoral amputation, TFA). The investigators plan to recruit 18 participants with TFA:
- Eight participants with TFA will complete 2 testing visits to examine whether practice influences results and to confirm that the protocol is feasible.
- Ten participants with TFA will be purposively sampled to ensure that their current socket includes features that can make the fit easy to adjust. Participants will complete 2 testing visits so the investigators can determine whether the system can measure differences in socket-limb coupling, using metrics such as movement duration and error.
The investigators will also compare these movement metrics with participants' self-reported Socket Comfort Scores. Showing that the test protocol is feasible to implement, the device operates as intended, and differences in coupling can be detected will give the investigators pilot data to support larger clinical trials.
Specific Aims
- Test the feasibility, repeatability and practice effects of the prototype socket fit testing protocol in people with transfemoral amputation.
- Show that the system can detect differences in socket fit in people with transfemoral amputation, using movement metrics such as duration and error.
- Validate the movement metrics by comparing them to patient-reported Socket Comfort Scores.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with transfemoral amputation | Other | Device: Prosthetic socket fit testing systemProsthetic socket fit testing system |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prosthetic socket fit testing systemProsthetic socket fit testing system to assess socket-limb coupling using movement error and duration. | Device | Individuals with transfemoral amputation |
Primary outcome
Repeatability
Time frame: 1 week
Assess repeatability of performing the prosthetic socket fit test in terms of movement time and accuracy.
3 secondary outcomes
Practice effects
Time frame: Day 1
Known groups validity
Time frame: Day 1
Convergent validity
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefania Fatone, PhD, BPO(Hons) principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prosthetic socket fit testing system in people with Amputation, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefania Fatone, PhD, BPO(Hons) (206-685-7918, sfaton@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repeatability (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.