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Clinical Trial NCT05124652 for Lower Limb Amputation Below Knee (Injury), Diurnal Residual Limb Fluid Volume Fluctuation is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation 100

Recruiting
Clinical Trial NCT05124652 is an interventional study for Lower Limb Amputation Below Knee (Injury), Diurnal Residual Limb Fluid Volume Fluctuation that is recruiting. It started on October 18, 2021 with plans to enroll 100 participants. Led by University of Washington, it is expected to complete by June 1, 2027. The latest data from ClinicalTrials.gov was last updated on September 29, 2022.
Brief Summary
People with leg amputations often experience daily changes in the size (volume) of their residual limb. These daily changes can cause a prosthesis to fit poorly. They can also cause limb problems like pain or skin breakdown. Prosthetic socket systems that accommodate limb volume changes can help address these issues, but they require users to make adjustments throughout the day. The aim of this research is to create ...Show More
Official Title

An Automatically-adjusting Prosthetic Socket for People With Transtibial Amputation

Conditions
Lower Limb Amputation Below Knee (Injury)Diurnal Residual Limb Fluid Volume Fluctuation
Other Study IDs
NCT ID Number
NCT05124652
Start Date (Actual)
2021-10-18
Last Update Posted
2022-09-29
Completion Date (Estimated)
2027-06
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
amputee
prosthetic
Primary Purpose
Basic Science
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
No InterventionFocus Group Testing
Focus group testing of key-fob device to control adjusting socket system
N/A
ExperimentalIn-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.
ExperimentalOut-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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Socket Comfort Score
Participants in Aim 2 and Aim 3 will test various configurations of the auto adjustment algorithm. Socket comfort score will be asked at various time points during testing, and overall changes in this metric will be calculated from the start and end of session.
through study completion, an average of 1 year
Integral Absolute Error of Control System
Calculated error will be measured through each test session, both in and out of lab.
through study completion, an average of 1 year
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Thermal Recovery Time (TRT)
An infrared (IR) camera will measure residual limb thermal recovery time at the beginning and end of testing--following at least 5 minutes of walking.
through study completion, an average of 1 year
Percent change in Limb Fluid Volume
Participant's limb fluid volume will be measured during the structured in-lab protocol (Aim 2), and changes will be compared against an initial reference point of activity during which no interventions will take place.
through study completion, an average of 1 year
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 18 or older (Prosthetists and Prosthesis Users)
  • 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)

  • Are not certified prosthetists (prosthetists only)
  • 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)
University of Washington logoUniversity of Washington398 active studies to explore
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) logoEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Responsible Party
Joan Sanders, Principal Investigator, Professor: Engineering, University of Washington
Study Central Contact
Contact: Katheryn Allen, CPO, 206-390-0228, [email protected]
Contact: Daniel Ballesteros, [email protected]
1 Study Locations in 1 Countries

Washington

William H. Foege Hall, Seattle, Washington, 98105, United States
Katheryn Allyn, Contact, 206-390-0228, [email protected]
Recruiting