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Prosthesis

Adjustable Prosthetic Foot for Lower Extremity Amputation

N/A

Recruiting

Led By Glenn K Klute, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Unilateral transtibial amputation

Wear the prosthesis for four or more hours on an average day

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during walking trials for each coupling ratio

Awards & highlights

Study Summary

This trial is testing a new kind of prosthetic foot that can be adjusted to the individual's needs. It is motor-driven and computer controlled, and the investigators hope to find the best coupling ratio for individuals with lower limb amputation.

Who is the study for?

This trial is for individuals with a single below-knee amputation who wear their prosthesis at least four hours daily and have been using it for over six months. Their current prosthesis must be compatible with the study's components, and they should not have any skin issues on the residual limb or conditions affecting walking ability.Check my eligibility

What is being tested?

The study tests different torsionally adaptive prostheses that mimic natural foot motion by varying coupling ratios between transverse (side-to-side) and sagittal (forward-backward) plane motions. Participants will walk straight and in circles while these ratios are adjusted without knowing which ratio they're testing.See study design

What are the potential side effects?

There may be discomfort due to changes in socket torque as the coupling ratio varies, but specific side effects aren't listed. The goal is to find a comfortable setting that minimizes unwanted forces on the stump.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had one lower leg amputated below the knee.

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I wear my prosthesis for at least 4 hours daily.

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I have been using a prosthesis for at least six months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately following walking trials for each coupling ratio

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately following walking trials for each coupling ratio

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately following walking trials for each coupling ratio for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Peak transverse-plane prosthetic socket torque

Secondary outcome measures

Satisfaction with the prosthesis

Trial Design

3Treatment groups

Experimental Treatment

Group I: Straight line walkingExperimental Treatment5 Interventions

All participants will walk in a straight line while wearing the study prosthesis.

Group II: Circle walking with prosthesis outsideExperimental Treatment5 Interventions

All participants will walk around a 1-meter radius circle with their prosthesis on the outside of the circle.

Group III: Circle walking with prosthesis insideExperimental Treatment5 Interventions

All participants will walk around a 1-meter radius circle with their prosthesis on the inside of the circle.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,438 Total Patients Enrolled

2 Trials studying Lower Extremity Amputation

40 Patients Enrolled for Lower Extremity Amputation

Glenn K Klute, PhDPrincipal InvestigatorVA Puget Sound Health Care System Seattle Division, Seattle, WA

4 Previous Clinical Trials

74 Total Patients Enrolled

2 Trials studying Lower Extremity Amputation

50 Patients Enrolled for Lower Extremity Amputation

Media Library

Torsionally Adaptive Prosthesis (Prosthesis) Clinical Trial Eligibility Overview. Trial Name: NCT03532100 — N/A

Lower Extremity Amputation Research Study Groups: Straight line walking, Circle walking with prosthesis inside, Circle walking with prosthesis outside

Lower Extremity Amputation Clinical Trial 2023: Torsionally Adaptive Prosthesis Highlights & Side Effects. Trial Name: NCT03532100 — N/A

Torsionally Adaptive Prosthesis (Prosthesis) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03532100 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For whom does this research endeavor allow participation?

"To be permissible for this clinical trial, a patient must have had lower limb amputation and fall within the ages of 18-70. A total of 15 patients are being accepted into the study."

Answered by AI

How many individuals can participate in this experiment?

"Affirmative, clinicaltrials.gov data verifies that this investigation is currently enrolling candidates. It was initially reported on April 18th 2018 and the most recent update occurred on March 16th 2022. 15 individuals are sought from a single research site."

Answered by AI

Are elderly adults eligible for enrollment in this research project?

"This medical study is available to those aged 18 and above but below the age of 70."

Answered by AI

Are there any opportunities for participants to sign up for this trial currently?

"Yes, according to clinicaltrials.gov records this trial is recruiting participants. It was first uploaded on April 18th 2018 and has been revised most recently on March 16th 2022, with the goal of enrolling 15 people at a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pivot-Flex Foot: Optimal Coupling Ratio Between Transverse and Sagittal-plane Motions Using a Torsionally Adaptive Prosthesis for Individuals With Lower Limb Amputation

2018. "Pivot-Flex Foot: Optimal Coupling Ratio Between Transverse and Sagittal-plane Motions Using a Torsionally Adaptive Prosthesis for Individuals With Lower Limb Amputation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03532100.