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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 below
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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 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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

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 more

Trial 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

Release/Relock Socket & Control (Prosthetic Device) Clinical Trial Eligibility Overview. Trial Name: NCT04305782 — N/A
Below Knee Amputation Research Study Groups: Release/Relock Socket - In Lab, Release/Relock Socket - Out of Lab, Release/Relock Socket & Control
Below Knee Amputation Clinical Trial 2023: Release/Relock Socket & Control Highlights & Side Effects. Trial Name: NCT04305782 — N/A
Release/Relock Socket & Control (Prosthetic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04305782 — N/A

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
~28 spots leftby Sep 2025