An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington
About this trial
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 a system that will automatically adjust the fit of the socket and create a well-fitting prosthesis for people with leg amputations who experience volume fluctuations when using their prosthesis.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18 years or older
Unilateral or bilateral trans-tibial amputation at least 12 months prior
Have a limb of length 9 cm or greater
Are capable of at least 5 minutes of continuous walking
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
Auto Adjusting Prosthesis
DeviceParticipants 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.
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: Focus Group TestingNo intervention 0 interventions
Group B: In-Lab, Crossover StudyExperimental treatment 1 intervention
Group C: Out-of-Lab Crossover StudyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
through study completion, an average of 1 year2
Integral Absolute Error of Control System
Calculated error will be measured through each test session, both in and out of lab.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
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.
Time frame
through study completion, an average of 1 year2
Residual limb health
Data collected using a standard skin assessment protocol and an IR imaging camera will be used. For IR data, thermal recovery time will be calculated and a difference map of TRT between the beginning and end test condition created
Time frame
Baseline and through study completion, an average of 1 year3
Prosthesis wear time
Socket fit sensor data will be used
Time frame
Up to 12 weeks4
Time of activities
Durations of walking, standing, sitting, sitting partially doffed, and doffed will be calculated for each day, using socket fit sensor and pin sensor data
Time frame
Up to 12 weeksOther outcomes
1
Number of manual socket size adjustments
This will be calculated using motor displacement data
Time frame
Up to 12 weeks2
Participant socket preference and qualitative interview responses
Information from the end of study interview will be tabulated
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Washington
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov