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Community Walking Trials: Comparing Prosthetic Feet

NCT03703232 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-06-21

Study results available
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Summary

The purpose of the study is to obtain performance measurements and participant feedback about use of an investigational prosthetic foot compared to the participant's usual prosthetic foot. To accomplish this, the study will use a combination of laboratory motion analysis, functional tests, and community mobility trials where participants complete questionnaires and interviews about use of an investigational prosthetic foot compared to the participant's usual prosthetic foot.

Individuals with amputations that participate in the (optional) motion analysis sub-study at the University of Washington will complete forward walking, side-step, and across river rock with usual foot (session 1), and also with the investigational foot locked and unlocked (session 2) after an accommodation period of between 1-4 weeks. The participants will rate their experiences using socket comfort score and the socket pressure score.

Control participants recruited at the University of Washington to provide information about performance for people without amputation will go through the consenting process, then will be asked to complete forward walking, Figure-of-8 Walk Test, Narrowing Beam Walking Test, side-step, and walking across river rock surface. These tests will be conducted at a single session.

Conditions

  • Lower Extremity Amputation

Interventions

DEVICE

Investigational prosthetic foot

Individuals will complete 2-4 weeks of community walking with the investigational foot and compare to their regular prosthetic foot.

Sponsors & Collaborators

Principal Investigators

  • Murray Maitland, PhD · University of Washington

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-15
Primary Completion
2021-06-30
Completion
2021-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03703232 on ClinicalTrials.gov