An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation
NCT ID: NCT05124652
Last Updated: 2022-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2021-10-18
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Focus Group Testing
Focus group testing of key-fob device to control adjusting socket system
No interventions assigned to this group
In-Lab, Crossover Study
Testing of auto-adjusting algorithm in-lab. Participants will carry out a structured protocol wearing the socket in all modes. Order will be randomly assigned.
Auto Adjusting Prosthesis
Participants will test the auto adjusting prosthesis. The prosthesis will be able to move up to 3 panels built into the socket walls to expand or tighten the socket's fit. The auto adjustments will take place during periods of sitting, standing, or walking. Manual adjustments will also be possible either via the researcher controlling the prosthesis or via the key fob developed in the first aim.
Out-of-Lab Crossover Study
Evaluate socket performance in user free-living environments. Participants will use the prosthesis in all modes by end of study, order will be randomly assigned.
Auto Adjusting Prosthesis
Participants will test the auto adjusting prosthesis. The prosthesis will be able to move up to 3 panels built into the socket walls to expand or tighten the socket's fit. The auto adjustments will take place during periods of sitting, standing, or walking. Manual adjustments will also be possible either via the researcher controlling the prosthesis or via the key fob developed in the first aim.
Interventions
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Auto Adjusting Prosthesis
Participants will test the auto adjusting prosthesis. The prosthesis will be able to move up to 3 panels built into the socket walls to expand or tighten the socket's fit. The auto adjustments will take place during periods of sitting, standing, or walking. Manual adjustments will also be possible either via the researcher controlling the prosthesis or via the key fob developed in the first aim.
Eligibility Criteria
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Inclusion Criteria
* must have certification and regularly treat patients with trans-tibial limb loss in a clinical setting (Prosthetists only)
* had a trans-tibial amputation at least 12 months prior (prosthesis users only)
* regularly use a definitive prosthesis with pin lock suspension and few or no pads (prosthesis users only)
* self-report experiencing limb volume fluctuation in the past (prosthesis users only)
* have residual limb length of at least 9 cm (prosthesis users, Aim 2 and Aim 3 only)
* walk at least 5 continuous minutes and intermittently at least 1 hour (prosthesis users, Aim 2 and Aim 3 only)
* capable of distinguishing socket sizes too large and too small to be tolerated (Prosthetists and Prosthesis Users)
Exclusion Criteria
* neuropathy (prosthesis users only)
* reduced skin sensation (prosthesis users only)
* regular use of an assisted device (prosthesis users only)
* sores or skin breakdown on their residual limb (prosthesis users, Aim 2 and Aim 3 only)
18 Years
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Washington
OTHER
Responsible Party
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Joan Sanders
Professor: Engineering
Principal Investigators
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Joan E Sanders, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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William H. Foege Hall
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00009418
Identifier Type: -
Identifier Source: org_study_id
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