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Prosthesis

Unlocked ankle articulation for Amputation

N/A

Recruiting

Led By Murray Maitland, PT, 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

At least one year post-amputation and using a prosthesis.

Ability to walk more than 400 m on level ground without an increase in pain.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 2-week trial of investigational foot condition 1 (b1), after 2-week trial of investigational foot condition 2 (b2) after return to usual foot for 2 weeks (a2).

Awards & highlights

Study Summary

This trial aims to understand how certain features in a prosthetic foot may help individuals with lower extremity amputations (LEA) improve their balance, reduce falls, manage pain, and participate in

Who is the study for?

This trial is for individuals with above-knee amputations, bilateral amputations, or below-knee amputations who have lower mobility levels. It aims to help them with balance, pain, and daily activities by testing a new type of foot prosthesis.Check my eligibility

What is being tested?

The study tests a novel foot prosthesis in two modes: locked and unlocked. Participants will be randomly assigned to use either mode and their usual prosthetic foot to compare performance, comfort, and mobility.See study design

What are the potential side effects?

While the trial does not list specific side effects, participants may experience discomfort or issues adjusting to the new prosthesis design during everyday activities.

Eligibility Criteria

Inclusion Criteria

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

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I have been using a prosthesis for over a year since my amputation.

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I can walk more than 400 meters without feeling more pain.

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My prosthetic foot fits US Men's shoe sizes 5 to 13.

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I weigh less than or equal to 365 lbs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 2-week trial of investigational foot condition 1 (b1), after 2-week trial of investigational foot condition 2 (b2) after return to usual foot for 2 weeks (a2).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 2-week trial of investigational foot condition 1 (b1), after 2-week trial of investigational foot condition 2 (b2) after return to usual foot for 2 weeks (a2).

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 2-week trial of investigational foot condition 1 (b1), after 2-week trial of investigational foot condition 2 (b2) after return to usual foot for 2 weeks (a2). for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

10-Meter Walk Test

Figure-of-8 Walk Test

The Four-square Step Test (FSST)

+2 more

Secondary outcome measures

Daily Activity Logbook: Balance Confidence

Spatiotemporal parameters of gait

Trial Design

2Treatment groups

Experimental Treatment

Group I: Unlocked ankle articulationExperimental Treatment1 Intervention

The design is a randomized cross-over clinical trial following an A1-B1-B2-A2 design. In the unlocked condition, the 20 degree of frontal plane ankle motion is enabled. The A conditions will be with the usual foot. The B conditions are randomized to the locked and unlocked investigational foot.

Group II: Locked ankle articulationExperimental Treatment1 Intervention

The design is a randomized cross-over clinical trial following an A1-B1-B2-A2 design. In the locked condition, the 20 degree of frontal plane ankle motion is eliminated by a physical lock. The A conditions will be with the usual foot. The B conditions are randomized to the locked and unlocked investigational foot.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,741 Previous Clinical Trials

1,847,670 Total Patients Enrolled

United States Department of DefenseFED

865 Previous Clinical Trials

327,603 Total Patients Enrolled

Murray Maitland, PT, PhDPrincipal InvestigatorUniversity of Washington

Frequently Asked Questions

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

Is the enrollment process currently open for this clinical trial?

"Indeed, the information found on clinicaltrials.gov confirms that this particular clinical trial is currently seeking eligible participants. The study was first listed on September 1st, 2023 and recently updated on January 9th, 2024. A total of 96 patients are being sought out from a single location."

Answered by AI

What is the current number of patients being recruited for participation in this medical study?

"Indeed, the details on clinicaltrials.gov confirm that this clinical trial is actively seeking eligible participants. The initial posting was made on September 1st, 2023, and the most recent update occurred on January 9th, 2024. The study aims to enroll a total of 96 individuals from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis

Murray Maitland 2023. "Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06214026.

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