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Prosthetic Device
Release/Relock Socket for Below Knee Amputation
N/A
Recruiting
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
Able to walk continuously with a prosthesis for at least 2 minutes at a time
Sit, stand, and negotiate a step of 5.0 cm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline period (no release/relock) to test period (release/relock), commonly each 1 hour long and separated by a seated period of approximately 30 minutes
Awards & highlights
Study Summary
This trial is testing a new way to manage daily residual limb fluid volume fluctuation.
Who is the study for?
This trial is for individuals who have had a below-knee amputation at least 18 months ago, can walk continuously for at least 90 seconds, and regularly use a definitive prosthesis with a pin-lock system. Their residual limb should be at least 9 cm long. People using walking aids, those with elevated vacuum sockets or open wounds on their residual limb cannot participate.Check my eligibility
What is being tested?
The study is testing a new socket technology designed to adjust to daily changes in limb volume. Participants will try the Release/Relock Socket both in lab settings and during regular activities outside the lab compared to their usual control socket.See study design
What are the potential side effects?
Since this trial involves mechanical devices rather than drugs, side effects may include discomfort or skin issues where the prosthetic meets the residual limb. The exact side effects will depend on individual fit and usage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk with a prosthesis for at least 2 minutes without stopping.
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I can sit, stand, and step over a 5 cm high obstacle.
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I wear a prosthesis for more than 7 hours a week.
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My residual limb is at least 9 cm long.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline period (no release/relock) to test period (release/relock), commonly each 1 hour long and separated by a seated period of approximately 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline period (no release/relock) to test period (release/relock), commonly each 1 hour long and separated by a seated period of approximately 30 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Limb Volume
PROMIS-Fatigue
Prosthesis Evaluation Questionnaire (PEQ)
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Release/Relock Socket - Out of LabExperimental Treatment1 Intervention
The test socket will be operated by the participant out of lab, with no structured protocol. This arm focuses on the effects of the re-lock panel and pin mechanisms on participant comfort.
Group II: Release/Relock Socket - In LabExperimental Treatment1 Intervention
The test socket will be operated by the participant in lab, following a structured protocol. This arm focuses on the order effects on the re-lock panel and pin mechanisms on limb volume.
Group III: Release/Relock Socket & ControlExperimental Treatment2 Interventions
The test socket will be operated by the participant out of lab, with no structured protocol. This arm focuses on the comparing participant experience using the novel mechanism versus traditional socket mechanisms.
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Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,956 Previous Clinical Trials
2,672,254 Total Patients Enrolled
University of WashingtonLead Sponsor
1,732 Previous Clinical Trials
1,841,852 Total Patients Enrolled
Joan E Sanders, PhDPrincipal InvestigatorUniversity of Washington
4 Previous Clinical Trials
294 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a below-the-knee amputation over 18 months ago.I can walk with a prosthesis for at least 2 minutes without stopping.I can sit, stand, and step over a 5 cm high obstacle.I currently have open sores on my skin.I wear a prosthesis for more than 7 hours a week.My residual limb is at least 9 cm long.
Research Study Groups:
This trial has the following groups:- Group 1: Release/Relock Socket - In Lab
- Group 2: Release/Relock Socket - Out of Lab
- Group 3: Release/Relock Socket & Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there now opportunities for individuals to partake in this exploration?
"Affirmative. According to the clinicaltrials.gov page, this research project has been open for recruitment since September 1st 2020 and was updated in April 2022. The team is hoping to enrol 100 people across a single site."
Answered by AI
How many people have been selected to participate in this investigation?
"Affirmative. According to records on clinicaltrials.gov, this research project is currently looking for volunteers and was initially posted on September 1st 2020. This investigation requires 100 participants at a single medical centre and the most recent update happened on April 1st 2022."
Answered by AI
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