N/A
N=104
Auto Control of Volume Management for Limb Loss
Lower Limb Amputation Below Knee (Injury)
Bottom Line
View on ClinicalTrials.gov: NCT03550118 ↗Enrolled (actual)
104
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Change in Limb Volume — 8; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Adjustable socket (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Limb Volume |
3; 12; 3; 0 | — |
| PRIMARY Change in Limb Movement |
0.01; -0.03 | — |
| PRIMARY Number of Participants With Increase in Limb Fluid Volume After Panel Pull |
8 | — |
| PRIMARY Integral of Absolute Error to Maintain Set Point |
0.003 | — |
| SECONDARY Adjustable Socket Mode Preference |
5; 5; 0 | — |
Summary
The aim of this research is to create a prosthetic 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
Inclusion Criteria
- 18 years of age or older
- Unilateral transtibial amputee
- At least 6 months post-amputation
- Wear prosthesis at least 3 hours per day
- Use an elastomeric (i.e. gel) liner
- K3 or higher Medicare Functional Classification Level
- Able to walk continuously with prosthesis for at least 5 minutes at a time, sit, stand, and step up a height of 5.0 cm.
- Residual limb of 9.0 cm or longer
- Experience problems with volume fluctuations that affect their prosthetic socket fit
Exclusion Criteria
- Participants experiencing skin breakdown on enrollment will be excluded, but can enter after having been free of clinically visually-apparent skin breakdown for two weeks.
Data sourced from ClinicalTrials.gov (NCT03550118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.