← Back to Search

Prosthetic Device

Adjustable socket for Below Knee Amputation

N/A
Waitlist Available
Led By Joan E Sanders, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline period (non-adjustment) to test period (adjustment), commonly each 1 hour long and separated by a seated period of approximately 30 minutes.
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to make a comfortable prosthetic for people with leg amputations that automatically adjusts to their changing body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline period (non-adjustment) to test period (adjustment), commonly each 1 hour long and separated by a seated period of approximately 30 minutes.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline period (non-adjustment) to test period (adjustment), commonly each 1 hour long and separated by a seated period of approximately 30 minutes. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Limb Movement
Change in Limb Volume
Integral of Absolute Error to Maintain Set Point
+1 more
Secondary study objectives
Adjustable Socket Mode Preference

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups
Experimental Treatment
Group I: Aim 9 - Panel Pull During AmbulationExperimental Treatment1 Intervention
Extending from the Aim #8 results, we sought to determine in Aim #9 if "vacuum-like" action during ambulation facilitated limb fluid volume recovery and retention. Vacuum-like action was achieved by quickly pulling the panels and liner (liner attached to panels) radially outward during late stance phase and then moving them back to their original position during early swing.
Group II: Aim 8 - Panel Pull During RestingExperimental Treatment1 Intervention
The purpose of Aim #8 was to determine if vacuum-like action ("panel pull") during resting between periods of activity facilitated limb fluid volume recovery and retention in transtibial prosthesis users. Liner attached to panels.
Group III: Aim 6B - Release/Recovery - Participant ControlsExperimental Treatment1 Intervention
An adjustable socket is tested where the study participant controls the adjustments. This arm focuses on a socket release and recovery mechanism that allows for full or partial doffing of the socket while seated.
Group IV: Aim 6A - Release/Recovery - Researcher ControlsExperimental Treatment1 Intervention
An adjustable socket is tested where researchers control the adjustments. This arm focuses on a socket release and recovery mechanism that allows for full or partial doffing of the socket while seated.
Group V: Aim 4 - Adjustable Socket - Automatic ControlsExperimental Treatment1 Intervention
An adjustable socket is tested where a control system is used to automatically control the adjustments. This arm focuses on socket size adjustments while walking.
Group VI: Aim 3 - Adjustable Socket - Participant ControlsExperimental Treatment1 Intervention
An adjustable socket is tested where the study participant controls the adjustments. This arm focuses on socket size adjustments while walking.
Group VII: Aim 2 - Adjustable Socket - Researcher ControlsExperimental Treatment1 Intervention
An adjustable socket is tested where researchers control the adjustments. This arm focuses on socket size adjustments while walking.
Group VIII: Aim 10 - Adjustable Socket Out of Lab TestingExperimental Treatment1 Intervention
Participants took the investigational device home in one of three test modes. In the first mode, the panels were in a "locked" flush position, similar to their traditional prosthesis. Participants were not able to adjust the panels in this first mode. The second mode allowed participants to manually make panel adjustments, incrementally enlarging or tightening the panels radially. Lastly, the third mode implemented the automated controller developed in the previous aims. Participants were still able to make manual adjustments to the panel positions but during walks adjustments would also occur automatically. Each mode was tested for a minimum of 1 week.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adjustable socket
2015
N/A
~110

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,809 Previous Clinical Trials
1,913,317 Total Patients Enrolled
Joan E Sanders, PhDPrincipal InvestigatorUniversity of Washington
4 Previous Clinical Trials
290 Total Patients Enrolled
~10 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top